All Disease Sites

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    Brain

    IDStudy TitleStatus
    CE8 (EORTC-1709-BTG)A Phase III Trial of Marizomib in Combination with Standard Temozolomide-Based Radiochemotherapy versus Standard Temozolomide-Based Radiochemotherapy Alone in Patients with Newly-Diagnosed Glioblastoma
    This study aims to compare the overall survival of patients receiving standard treatment (Temozolomide-based radiochemotherapy followed by adjuvant temozolomide) for newly diagnosed Glioblastoma to those receiveing marizomib in combination with standard treatment. This comparision will be made across the entire patient population as well as the unmethylated MGMT subpopulation. This study will also examine patient neurocognitive function, quality of life and the saftey of marizomib combined with standard treatement.
    A Phase III Trial of Marizomib in Combination with Standard Temozolomide-Based Radiochemotherapy versus Standard Temozolomide-Based Radiochemotherapy Alone in Patients with Newly-Diagnosed Glioblastoma

    Complexity Level: 2

    Eligibility: WHO grade IV glioblastoma - Tumor resection or biopsy only - Availability of FFPR tumour block or slide for mandatory MGMT analysis - eligible for standard TMZ/RT ->TMZ - KPS>=70 - Recovered from effects of surgery - 18 years of age when ICF signed - stable or decreasing dose of steroids for 1 week prior - life expectancy of 3 months - Adequate organ function as per lab values - negative serum pregnancy test 7 days prior to first dose - no IDH1 mutation - no prior treatment for GBM other than surgery - planned treatment with TTF

    Objectives: To compare the overall survival of glioblastoma patients treated with standard TMZ?-based radiochemotherapy alone or TMZ?-based radiochemotherapy in combination with marizomib. Additonally, PFS survival will be compared in the two treatment arms. Additionally the saftey and tolerability of TMZ?-based radiochemotherapy in combination with marizomib will be assesed. The neurocognitive function and OoL of the MRZ arm will also be assesed.

    NCT Registration ID (from clinicaltrials.gov): NCT03345095
    Participation: Limited to invited centres; Site Selection Open
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: May 24, 2018



    Open to Accrual
    CEC6 (ALLIANCE N0577)Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
    The purpose of this study is to compare the effectiveness of 1) radiotherapy followed by PCV chemotherapy to 2)radiotherapy with temozolomide chemotherapy followed by additional temozolomide chemotherapy in the treatment of anaplastic glioma and low grade glioma, which are types of brain tumours. In this study, the patient's tumour cells are missing parts of chromosomes 1 and 19. Chromosomes are components of cells in the body which contain genetic information. These chromosomes are missing parts only in the tumour cells and are not typically missing in normal body cells. Tumours with this 1p/19q co-deletion typically have a more favorable outcome than other types of anaplastic glioma or low grade glioma.
    Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

    Complexity Level: 2

    Eligibility: Pre-registration - Inclusion Criteria Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. Registration Inclusion Criteria >18 years of age; Newly diagnosed and <3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade 2 or 3]) or low grade glioma (WHO grade 2), as determined by pre-registration central pathology review, and tumor is co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible. Patients with codeleted low grade gliomas must also be considered "high risk." Tumor tissue must show co-deletion of chromosomes 1p and 19q by FISH analysis. Surgery must be performed >2 weeks prior to registration. Patient must have recovered from the effects of surgery; The following laboratory values obtained <21 days prior to registration: ANC>1500/mm^3; PLT>100,000/mm^3; Hgb>9 g/dL; Total bilirubin<1.5 x UNL; SGOT (AST)<3 x UNL; Creatinine<1.5 x ULN

    Objectives: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide have a marginally better progression free survival as compared with patients who receive radiotherapy followed by PCV.

    NCT Registration ID (from clinicaltrials.gov): NCT00887146
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 22, 2016



    Open to Accrual
    CE7 (CCTG CE.7)A Phase III Trial of Stereotactic Radiosurgery compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases
    Testing stereotactic radiosurgery, a type of targeted radiation therapy, versus whole brain radiotherapy in people with cancer that has spread to the brain.
    A Phase III Trial of Stereotactic Radiosurgery compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases

    Complexity Level: 2

    Eligibility: - Patient must have 5 or more brain metastases by MRI obtained within 30 days of registration. Largest brain metastasis must be <2.5cm, and total tumour volume must be 30cm3 or less - Patient must be willing and able to complete QoL questionnaires, neurocognitive assessments, and must agree to use effective contraception if of child bearing potential - Centre must be IROC credentialied and able to treat patients using an SRS system - Patient must have a pathological diagnosis of a non-hematopoietic malignancy - Patient must be >18 years old, ECOG 0-2, and creatinine clearance of 30ml/min or more

    Objectives: Primary Endpoints: - Overall Survival and neurocognitive PFS Secondary Endpoints: - time to CNS failure; difference in CNS failure patterns;number of salvage procedures following SRS; cognitive tests; adverse events; time delay to re-initiation of systemic therapy post treatment; validate nomogram; Health Economics; Quality of Life; Correlative Studies; Imaging data collection and evaluation

    NCT Registration ID (from clinicaltrials.gov): NCT03550391
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: May 25, 2018



    On Hold
    CE5 (EORTC 22033-26033)Primary Chemotherapy with Temozolomide vs. Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study.
    The purpose of this study is to compare the effects on you and your low-grade glioma of a new drug temozolomide to radiotherapy treatment which is usually used to treat this disease. This research is being done because we do not know which of these two treatments is better for low-grade glioma.
    Primary Chemotherapy with Temozolomide vs. Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study.

    Complexity Level: 2

    Eligibility: At registration: -Histologically proven low grade diffuse glioma (Astrocytoma WHO grade II , gemistocytic, fibrillary and protoplasmatic), Oligoastrocytoma WHO grade II and oligodendroglioma WHO II); supratentorial location only -WHO performance status <2; Age > 18 years; Informed consent; At randomization : Same as above +; Requiring treatment as demonstrated by at least one of the following criteria (1-4): 1. Age >40 years; 2. Radiologically proven progressive lesion; 3. Neurological symptoms others than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits); 4. Intractable seizures; Not candidate for treatment exclusively by surgery; RTOG neurological function 0-3; Results of genetic testing (1p) available; Adequate hematological, renal and hepatic function; No previous radiotherapy to the brain, no prior chemotherapy, patient EORTC 22033-26033 RTX vs. TMZ in LGG stratifying for 1p loss; has recovered from any surgery; No second primary exc BCC skin

    Objectives: Primary: PFS Secondary: Overall survival, Quality of life and Minimental State Examination (MMSE), Adverse events, neurocognitive function (for dedicated centers)

    NCT Registration ID (from clinicaltrials.gov): NCT00182819
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 06, 2006 Closing Date: March 28, 2013



    Closed to Accrual
    CE5S (NCIC CTG)Socio-behavioral Study Work, Marriage/Social Support, Anxiety and Depression NCIC CTG CE5S
    We are hoping to see how coping with a brain tumour and its treatment impacts your mood, social support, work and financial status. We are particularly interested in seeing how things might change throughout your treatments and in survivorship.
    Socio-behavioral Study Work, Marriage/Social Support, Anxiety and Depression NCIC CTG CE5S

    Complexity Level: 3

    Eligibility: Histologically proven low-grade glioma. Astrocytoma WHO grade II, Obligoastrocytoma WHO grade II, Oligodendroglioma WHO grade II, Supratentorial tumor location only, WHO performance status < or =2, Age > or =18, no previous chemo/rad for brain tumour.

    Objectives: The goal of this supplemental evaluation is to add a socio-behavorial component to the CE5 protocol in order to provide a more detailed description of important social (marital status), emotional (depression, anxiety) and occupational (work status) consequences of low grade glioma and its treatments.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: January 22, 2007 Closing Date: April 11, 2013



    Closed to Accrual
    CEC1 (RTOG 0834)Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
    This study investigates the addition of chemotherapy with temozolomide to radiotherapy. Patients recently operated upon for a primary brain tumor, called an anaplastic glioma (or more specifically, an anaplastic astrocytoma, an anaplastic oligoastrocytoma or an anaplastic oligodendroglioma). The doctor will plan further treatment for the patient, which may consist of radiotherapy, chemotherapy or a combination of both.
    Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

    Complexity Level: 2

    Eligibility: Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis

    Objectives: To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma.

    NCT Registration ID (from clinicaltrials.gov): NCT00626990
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 22, 2009 Closing Date: September 15, 2015



    Closed to Accrual
    CEC3 (NCCTG N107C)A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

    A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

    Complexity Level: 1

    Eligibility: Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions. Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site.

    Objectives: Primary: Overall Survival, Cognitive Function Secondary: Local Control Of The Surgical Bed; Time To CNS Failure; Various Quality Of Life; A Biologic Correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01372774
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 29, 2011 Closing Date: December 18, 2015



    Closed to Accrual
    CEC5 (ALLIANCE A221208)Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases
    This investigation compares the effects of bevacizumab plus standard corticosteroid therapy to placebo plus standard corticosteroid therapy on brain radionecrosis in patients who received radiosurgery for brain cancer. Brain radionecrosis is a non-cancerous condition that makes up an area of dead tissue in the brain that is surrounded by inflamed (swollen) tissue. This condition can happen after a patient receives intense radiation therapy for brain cancer, such as if they have radiosurgery. The standard corticosteroid treatment only works for some patients and can cause significant side effects. The purpose of this study is to test whether adding bevacizumab to the standard corticosteroid therapy will improve the symptoms over corticosteroid therapy alone by improving the radionecrosis and minimizing treatment-related side effects.
    Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have a diagnosis of radionecrosis based on a clinical onset of symptoms and radiological findings of radionecrosis at 3 - 24 months following radiosurgery for brain metastases, with or without pathological confirmation. For this trial, the primary solid tumour indicating brain metastases includes, but is not limited to: lung, breast, colorectal cancer, but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas (due to high risk of intratumoural hemorrhage). Prior to the start of treatment patient must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI. Patients will have a Karnofsky Performance Status > 60%. It is required that patients do not have any systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration (with exceptions) nor any bevacizumab within 3 months of study registration.

    Objectives: Primary Objective:To investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms (clinical and patient-reported symptom improvement associated with radionecrosis and less radionecrosis treatment-induced symptoms) compared with standard corticosteroid therapy. Secondary Objectives:To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy.To compare self-reported health related quality of life (HRQOL) using LASA, Dexamethasone Symptoms Questionnaire-Chronic (DSQ-C), and MDASI-BT symptom and interference score between treatment arms.To compare intracranial progression-free survival and time to maximum radiographic response between treatment arms.To compare the dose and duration of corticosteroid required between treatment arms and correlate steroid requirement with DSQ-C and MDASI-BT scores.Correlative Objectives:To explore serum/urine/imaging biomarkers that predict for treatment response.

    NCT Registration ID (from clinicaltrials.gov): NCT02490878
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: December 23, 2016 Closing Date: October 12, 2018



    Closed to Accrual
    CEC2 (NCCTG N0577)Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma
    The two main reasons this research study is being done are to see if: " people have longer survival if they get treatment with the combination of both radiation therapy and temozolomide chemotherapy as compared to people who receive treatment with radiation therapy alone. " people treated with temozolomide therapy alone (no radiation therapy) have a better or worse quality of life and mental function than those patients who are treated with either the combination of radiation therapy and temozolomide or radiation therapy alone. Survival will also be monitored in the people getting temozolomide alone.
    Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma

    Complexity Level: 2

    Eligibility: Pre-registration . Inclusion Criteria - Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible. Inclusion Criteria >18 years of age; Newly diagnosed and .3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III]), as determined by pre-registration central pathology review, and tumor is also co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q; 3.24 Surgery .2 weeks prior to registration must have recovered from the effects of surgery; The following laboratory values obtained 21 days prior to registration. . ANC .1500; . PLT .100,000; . Hgb>9; Total bilirubin .1.5 x UNL; SGOT (AST) .3 x UNL; Creatinine .1.5 x ULN

    Objectives: Survival; Progression Free Survival; Quality of Life; Cognitive Function; Correlative Biology.

    NCT Registration ID (from clinicaltrials.gov): NCT00887146
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 28, 2010 Closing Date: January 14, 2015



    Closed to Accrual
    CE2 (RTOG 94-02)Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas.
    The purpose of the study is to find out the best way to use chemotherapy in the treatment of oligodendrogliomas. Should chemotherapy be given at an early stage together with radiotherapy, or only given if the tumor regrows after radiation? To do this, half of the patients in the study will get chemotherapy (PCV) and radiation after diagnosis and the other half will receive radiation alone but PCV may be given late if the radiation fails.
    Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas.

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed supratentorial pure or mixed anaplastic oligodendrogliomas who have not received prior radiotherapy or chemotherapy and do not have chronic lung disease; a Karnofsky performance status of > 60 and adequate blood counts, liver and kidney function required.

    Objectives: To compare overall survival and time to tumour progression in patients treated with intensive-PVC (procarbazine, CCNU [lomustine] and vincristine)followed by radiation to those patients treated with radiation alone. Also to compare the frequencies of severe toxicities, quality of life and neurologic function between the two arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00002569
    Participation: Limited to centres 1) which are not currently RTOG members; 2) with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 23, 1996 Closing Date: March 29, 2002



    Permanently Closed
    CE1NCIC Cooperative Clinical Trial on Treatment of Cerebral Tumours (Glioblastomas) With Pre-Operative BCNU and Superfractionated Radiotherapy

    NCIC Cooperative Clinical Trial on Treatment of Cerebral Tumours (Glioblastomas) With Pre-Operative BCNU and Superfractionated Radiotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 05, 1980 Closing Date: December 15, 1981



    Permanently Closed
    CE4 (26021)Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study.
    The purpose of this study is to find out whether adding irradiation after a benign intracranial meningioma has been removed with surgery will increase the likelihood of patients with remaining tumour having a longer time to recurrence compared to the current standard treatment of surgery alone. This research is being done because although the current standard treatment is surgical removal of the benign tumour, in some cases, the meningioma cannot be completely removed. The researchers would like to study whether irradiation is a better alternative to watchful observation after surgical removal of the tumour. This study will also compare the quality of life, overall survival and likelihood of a second surgery between patients who do not undergo any further treatment and patients who will receive irradiation.
    Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study.

    NCT Registration ID (from clinicaltrials.gov): NCT00104936
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 29, 2005 Closing Date: October 23, 2006



    Permanently Closed
    CE6 (CE6)A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients.
    Glioblastoma Multiforme (GBM) is a type of brain cancer treated with surgery and radiation therapy (RT). Temozolomide (TMZ) is a new drug. A previous clinical study in GBM patients up to 71 years of age showed that when TMZ is added to the usual (i.e. "long") course of RT it slows the growth of GBM and prolongs life compared to treatment with the long course of RT alone. However, the results of this trial suggested that the benefit from TMZ decreases with increasing age. Also, elderly patients are not usually able to tolerate the long RT course and are instead perscribed a shorter one. Thus, researchers do not know if TMZ is of benefit to elderly patients, neither do they know if its combination with the short course of RT will be as effective as with the long course of RT. CE.6 will attempt to answer these questions by enrolling GBM patients 65 yers or older who are not considered suitable for the long course RT. Patients will be randomized to short RT alone or to short RT plus TMZ.
    A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients.

    Complexity Level: 2

    Eligibility: Patients 65 years of age or older, with newly diagnosed, histopathologically confirmed, glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide.

    Objectives: PRIMARY: To compare the overall survival (OS) rates between short-course radiation therapy alone and short-course radiation therapy given together with concurrent and adjuvant temozolomide, in elderly (65 years of age or older) patients with newly diagnosed glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide. SECONDARY: To compare progression-free survival (PFS) between the two arms; To compare the nature, severity, and frequency of adverse events between the two arms; To compare the quality of life between the two arms using the EORTC QLQ-C30 and the EORTC Brain Cancer Module (QLQ-BN20); To conduct molecular correlative studies (mandatory: MGMT promoter status; optional: tissue banking).

    NCT Registration ID (from clinicaltrials.gov): NCT00482677
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 2007 Closing Date: October 01, 2013



    Permanently Closed
    CE3 (26981-22981)A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme
    The purpose of this study is to look at whether treatment with temozolomide during and after radiation therapy improves survival and quality of life in patients with a newly diagnosed GBM, compared to radiation therapy alone. Despite these treatments these tumors cannot be cured and they eventually recur. Therefore, new treatments are being investigated to treat patients with GBM.
    A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme

    Eligibility: Patients with histologically confirmed newly diagnosed glioblastoma multiforme who have not received prior chemotherapy or radiotherapy; 18 to 70 years of age; WHO performance status < 2; stable, non-increasing dose of corticosteroids; adequate blood counts, liver and kidney function.

    Objectives: The primary objective of the trial is to test the efficacy of administration of temozolomide as a concomitant and adjuvant treatment to radiotherapy with respect to overall survival compared to radiotherapy alone. The secondary objectives are to compare the two treatment arms with respect to toxicity profile, progression free survival and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00006353
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 29, 2000 Closing Date: March 22, 2002



    Permanently Closed

    Breast

    IDStudy TitleStatus
    MAC25 (NRG-BR004)A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2 Positive Metastatic Cancer
    This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, pertuzumab, and atezolizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells.
    A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2 Positive Metastatic Cancer

    Complexity Level: 2

    Eligibility: This study will recruit women and men =>18 with a Zubrod Performance Status =< 1 with histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease (HER 2-positive). Patients must have measurable disease based on RECIST 1.1. Patients must have adequate hematologic, hepatic and renal function within 14 days prior to randomization. Patients must not have cardiac disease history and history or risk of autoimmune disease.

    Objectives: Primary objective is to determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival, assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo in patients with newly documented HER2-positive measurable metastatic breast cancer. Secondary objective is to determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will: improve the overall survival relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo; improve the overall objective response, assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo; improve PFS, OR, and/or duration of objective response assessed by retrospective blinded central review using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzuma and placebo.

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    MAC26 (SWOG S1706)A Phase II Randomized, Double-Blinded, Placebo-Controlled Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy for Inflammatory Breast Cancer
    This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
    A Phase II Randomized, Double-Blinded, Placebo-Controlled Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy for Inflammatory Breast Cancer

    Complexity Level: 2

    Eligibility: Patients must be =>18 with a Zubrod Performance Status =< 2. Patients must have adequate:hematologic, renal and hepatic function. Patients must not have:a history of other prior malignancy or uncontrolled infection;a history of resting ECG indicating uncontrolled potential reversible cardia conditions symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia; MDS/AML; Major surgery within 2 weeks of starting study treatment; history of uncontrolled ventricular arrhythmia; previous allogenic bone marrow transplant; whole blood transfusions. Patients must be able to swallow and retain oral medication.

    Objectives: Primary objective is to compare the Invasive Disease-Free Survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. Secondary objective is to compare the effect of concurrent administration of olaparib with radiotherapy versus radiotherapy alone on improvement in locoregional control (measured by Locoregional Recurrence-Free Interval), Distant Relapse-Free Survival, and Overall Survival in inflammatory breast cancer patients.

    NCT Registration ID (from clinicaltrials.gov): NCT03598257
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    MA36 (BIG 6-13)A Randomised, Double-Blind, Parallel group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
    The purpose of this study is to find out whether it is better to receive a new drug, olaparib, or better to receive no further treatment after surgery for breast cancer. To do this, half of the participants in this study will get olaparib and the other half will receive a placebo (a substance that looks like the study drug but does not contain an active drug).
    A Randomised, Double-Blind, Parallel group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: For inclusion in the study patients should fulfil the following criteria: Provision of informed consent prior to any study specific procedures, female or male patients must be greater than or equal to 18 years of age, histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast that is at surgery: either axillary node-positive (any size) or node negative with primary tumour >2cm for patients who received adjuvant chemotherapy or showing evidence of non pCR for patients who received neoadjuvant chemotherapy. Patients must have a documented mutation in BRCA1 or BRCA2 predicted or suspected deleterious. Submission of (FFPE) tumour sample from the primary tumor is mandatory.

    Objectives: The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS. Secondary objectives aretTo assess the effect of adjuvant treatment with olaparib on overall survival (OS), to assess the effect of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS), to assess the effect of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer, to assess the effect of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale and to assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).

    NCT Registration ID (from clinicaltrials.gov): NCT02032823
    Participation: Limited to invited centres; Site Selection Closed
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: July 20, 2015



    Open to Accrual
    MA39 (CCTG MA.39)Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
    Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with low risk breast cancer need to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to compare the effects on women with low risk breast cancer of receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.
    Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

    Complexity Level: 2

    Eligibility: 1) Newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases. 2) Must have been treated by BCS or mastectomy. 3) If treated by BCS or mastectomy and axillary dissection must have 1-3 positive axillary nodes. 4) If treated by BCS and SLNB alone must have only 1-2 positive axillary nodes. 5) If treated by mastectomy and SLNB alone must have only 1 positive axillary node. 6) Must be ER greater than or equal to 1% and Her2 negative on local testing. 7) Must have an Oncotype DX recurence score of less than 18. 8) Must consent to provision of tissue and blood for mandatory correlative studies 9) Must have had endocrine therapy initiated or planned for greater than or equal to 5 years 10) ECOG performance status must be 0,1 or 2. 11) Age must be greater than or equal to 40 years. 12) Life expectancy must be greater than or equal to 10 years.

    Objectives: Primary: To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC. Secondary: 1) Invasive disease-free survival (DFS); 2) Breast cancer mortality; 3) Overall survival (OS); 4) Locoregional recurrence-free interval (LRRFI); 5) Distant recurrence-free interval (DRFI); 6) Toxicity; 7) Arm volume and mobility 8) Patient reported outcomes (PROs) and Quality of Life (QOL); 9) Cost effectiveness Tertiary: 1) To establish a comprehensive tumour bank; 2) To evaluate the ability of intrinsic subtype to predict study outcomes and the effect of regional RT on these outcomes; 3) To evaluate other radiation signatures to prognosticate and predict effect of regional RT; 4) To describe the prevalence of ctDNA and evaluate its prognostic ability

    NCT Registration ID (from clinicaltrials.gov): NCT03488693
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: May 30, 2018



    Open to Accrual
    MAC18 (ALLIANCE A221405)POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy
    The purpose of this study is to find out whether having a child after temporarily stopping endocrine treatment is feasible and safe in patients with a hormone receptor-positive early breast cancer.
    POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy

    Complexity Level: 3

    Eligibility: Premenopausal women with endocrine responsive early breast cancer who received adjuvant endocrine therapy for 18 to 30 months, are between 18 and 42 years of age at enrollment, and wish to interrupt endocrine therapy to attempt pregnancy.

    Objectives: Primary objective: To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy (ET) to permit pregnancy. Secondary objective: To evaluate factors associated with pregnancy success after interruption of endocrine therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT02308085
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 16, 2016



    Open to Accrual
    MAC20 (ALLIANCE A011401)Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
    This study will evaluate the effects of a weight loss intervention and/or a health education program on overweight or obese women with breast cancer. You are eligible to join this study if you are aged 18 years or above and have been diagnosed with HER2-negative breast cancer, for which you have already received treatment. Participants in this trial will be randomly (by chance) be allocated to one of two groups. Participants will either receive a Health Education Program alone (Group 1) or in addition to a supervised 2-year weight loss program (Group 2). All participants will receive information about breast cancer and other health issues, a newsletter, and invitations to take part in webinars and teleconferences. If you are in Group 2, you will also be enrolled in a weight loss program designed to help you lose about 10% of your starting weight through changes in diet and physical activity. This program will be provided through a series of telephone calls over 2 years.
    Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

    Complexity Level: 3

    Eligibility: Adult women with histologic diagnosis of invasive HER2 negative breast cancer within the past 12 months, who have a BMI >=27 kg/m^2 at the time of enrollment, who have completed all adjuvant or neoadjuvant chemotherapy and surgery, who do not have diabetes or comorbid conditions that would cause life expectancy of <4 years, and who have a self-reported ability to walk at least 2 blocks (at any pace).

    Objectives: Primary Objective: Effect of supervised weight loss intervention plus health education materials vs. health education materials alone on invasive disease free survival in overweight and obese women. Secondary Objectives: Relationship between weight change and iDFS/clinical benefit; OS, distant DFS, weight/body composition, insulin resistance; Impact of supervised weight loss intervention on iDFS within subgroups of women (hormone receptor positive vs. negative breast cancer; premenopausal vs. menopausal); Quality of Life (QoL); physical activity and dietary intake; Patient reported outcomes (PRO).

    NCT Registration ID (from clinicaltrials.gov): NCT02750826
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: November 11, 2016



    Open to Accrual
    MAC23 (ALLIANCE A221505)RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction
    Testing the safety and breast cancer patient experience of short course radiation after mastectomy and breast reconstruction
    RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction

    Complexity Level: 2

    Eligibility: This study will recruit women and men >=18 post mastectomy due to invasive breast cancer with planned chest wall reconstruction and radiation. Patients will be approached based on the following main criteria: no prior radiation therapy to the chest, neck or axilla, no prior history of ipsilateral breast cancer, no history of prior or concurrent contralateral invasive breast cancer, negative inked histologic margins from mastectomy pathology and Zubrod performance status of 0-1

    Objectives: To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. Secondary objectives include: acute and late radiation complications, based on CTCAE 4.0 toxicity, local and local regional recurrence rate, photographic cosmesis 24 months after radiation, lymphedema at 24 months after radiation, patient satisfaction and well-being at 24 months after radiation (BreastQ,)compare reconstruction complication rates based on reconstruction method and timing of reconstruction, cost and healthcare utilization based on hypofractionation and reconstruction technique

    NCT Registration ID (from clinicaltrials.gov): NCT03414970
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 27, 2018



    Open to Accrual
    MAC22 (ECOG-ACRIN EA1151)Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
    This trial is intended to determine whether tomosynthesis (TM) should replace digital mammography (DM) for breast cancer screening as determined by the effect of each technology on the development of advanced breast cancers in the population of women being screened. If TM is better at finding important breast cancers, i.e. the sorts of cancers that are most likely to advance and kill women, over time, one would expect those cancers to decrease in number in the population being screened with TM compared to the population being screened with DM.
    Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

    Complexity Level: 3

    Eligibility: Patients must be women between the age 45 and 75 at the time of study entry. Women of childbearing potential must not be known to be pregnant or lactating Patients must be scheduled for, or have intent to schedule, a screening mammogram Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol. Written informed consent No symptoms or signs of benign or malignant breast disease No screening mammogram within the last 11 months prior to date of randomization No previous personal history of breast cancer including ductal carcinoma in situ No breast enhancements

    Objectives: To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen

    NCT Registration ID (from clinicaltrials.gov): NCT03233191
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: October 13, 2017



    Open to Accrual
    MAC21 (ALLIANCE A011502)A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial
    The purpose of this study is to compare any good and bad effects of using aspirin after someone has completed the usual chemotherapy, surgery and/or radiation therapy for breast cancer. This study will evaluate whether patients taking aspirin once per day will have a lower rate of cancer recurrence than patients taking a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients).
    A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

    Complexity Level: 3

    Eligibility: Histologic documentation of women or men with node-positive, HER2 negative, anatomic Stage II or III breast carcinoma or high risk node negative (defined as ER negative and tumor size >2 cm)within one year of diagnosis and free of recurrence. Patients with pN1mic are eligible. Patients must be enrolled within 1 year after diagnosis. Patients must be >= 18 and < 70 years of age. ECOG performance status 0-2. Any ER/PgR status allowed.

    Objectives: Primary Objective: To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients. Secondary Objectives: To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon: a) Distant disease-free survival, b) Overall survival, c) Cardiovascular disease, To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers. To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation

    NCT Registration ID (from clinicaltrials.gov): NCT02927249
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: September 29, 2017



    Open to Accrual
    MAC19 (ALLIANCE A011202)A Randomized Phase III Trial Evalulating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
    The purpose of this study is to examine whether removing some of the lymph nodes from the arm pit, but not removing them all, followed with radiation therapy (experimental) will be as good as having the majority of the lymph nodes from the arm pit removed during breast surgery followed with radiation (standard of care.
    A Randomized Phase III Trial Evalulating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: Inclusion criteria: - Female or male >/= 17 years - T1-3, N1, M0 clinical stage - Axillary FNA or core biopsy documenting nodal disease - Invasive breast cancer - ER,PR, Her2 testing on breast core biopsy - Completed at least 6 cycles of neoadjuvant chemo - Anti Her 2 therapy if positive - Negative axilla on P/E after completion of NAC - Surgery
    Objectives: Primary: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.

    NCT Registration ID (from clinicaltrials.gov): NCT01901094
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: December 17, 2015



    Open to Accrual
    MAC24 (SWOG 1418)A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ? 1 cm Residual Invasive Cancer or Positive Lymph Nodes (pN1mic) After Neoadjuvant Chemotherapy
    This study is designed to test if inhibiting immune checkpoint mechanisms, with MK-3475, will increase the efficacy of the local anti-tumor immune response which could translate into increased recurrence-free survival and higher cure rates for TNBC patients.
    A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with ? 1 cm Residual Invasive Cancer or Positive Lymph Nodes (pN1mic) After Neoadjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: Histologicaly confirmed triple negative breast cancer, must not have metastatic or locally recurrent disease, must have available minimum of five unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node. Patients must have had neoadjuvant chemotherapy followed by surgery, completed their final breast surgery, must be 18 years or older, and Zubrod Performance Status of 2 or less

    Objectives: Primary objective is to compare invasive disease-free survival of patients with triple-negative breast cancer who have either >/=1 cm residual invasive breast cancer and/or positive lymph nodes (>ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 adjuvant therapy compared to no MK-3475, in both the entire study population and also in the PD-L1 positive subset. Secondary objectives: 1. To compare the effects of MK-3475 on overall survival and distant recurrence-free survival between the two randomized arms for the PD-L1 positive patients and then all patients.2. To assess the toxicity and tolerability of MK-3475 in this patient population with or without radiation therapy. BAHO Study objectives: 1.examine the association between biomarkers of inflammation and quality of life and patient-reported outcomes between the two groups during and at the end of therapy and to examine the long-term and late effects of treatment on patient-reported outcomes.

    NCT Registration ID (from clinicaltrials.gov): NCT02954874
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: December 11, 2018



    Open to Accrual
    MA26 (RTOG 9804)Phase III Trial of Observation +/- Tamoxifen Vs. Rt +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) of The Female Breast
    The purpose of this study is to compare the effects on the patient and their breast cancer of treatment with radiation therapy with or without tamoxifen, compared to the standard practice of careful observation with or without tamoxifen which is the way this disease is commonly treated.
    Phase III Trial of Observation +/- Tamoxifen Vs. Rt +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) of The Female Breast

    Complexity Level: 2

    Eligibility: Women > 26 years of age, with unicentric mammographically detected DCIS, < 2.5 cm in greatest dimension. Lesions must be classified as low or intermediate grade DCIS. Patients must be clinically node negative.

    Objectives: In the defined good-risk group, assess the role of whole breast radiation +/- tamoxifen compared to wide excision to negative margins alone +/- tamoxifen, in decreasing or delaying the appearance of local failure, both invasive and in-situ, and preventing the need for mastectomy. Assess distant disease free survival, adopt a working pathology classification system for DCIS, establish a registry for patients with an epidemiological questionnaire, and to establish a tissue bank of patients who progress to local failure in the study breast.

    NCT Registration ID (from clinicaltrials.gov): NCT00003857
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 09, 2002 Closing Date: July 14, 2006



    Closed to Accrual
    MA32 (MA32)A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

    A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

    Complexity Level: 2

    Eligibility: Breast cancer T1C-3, NO-3, M0

    Objectives: Invasive disease free survival. Overall survival; distant disease-free survival; breast cancer free interval; invasive disease free survival in hormone receptor (ER and PgR) negative sub group; changes in body mass index; adverse events; other medical endpoints including a new diagnosis of diabetes mellitus or cardiovascular hospitalization or death (stroke, mycardial infarction); health related quality of life; correlative science outcomes; metabolic parameters and hospitalizations.

    NCT Registration ID (from clinicaltrials.gov): NCT01101438
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: June 25, 2010 Closing Date: January 22, 2013



    Closed to Accrual
    MA32D (ALLIANCE A211201)Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32

    Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32

    Complexity Level: 3

    Eligibility: Eligible patients must be either concurrently enrolling or previously enrolled to NCIC study MA.32. Eligible patients may be either pre- or post-menopausal. Patients must have hormone receptor-negative breast cancer. Patients must have breast density measurement as defined by either: >/= 25% density, or fibroglandular densities, or BIRAD-2 category or greater. Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to NCIC MA.32 must be available for submission. If the patient has previously enrolled to MA.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission. Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible. Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study).

    Objectives: To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin or placebo treatment through one year of therapy in patients with hormone receptor negative breast cancer (i.e. not on endocrine therapy).

    NCT Registration ID (from clinicaltrials.gov): NCT01666171
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 18, 2015 Closing Date: October 13, 2017



    Closed to Accrual
    MA37 (BIG 14-03)PALLAS: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer
    A randomized trial of treatment with palbociclib and standard anti-hormone therapy compared with standard anti-hormone therapy alone in patients with hormone receptor positive/HER2 negative early breast cancer
    PALLAS: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

    Complexity Level: 2

    Eligibility: Premenopausal and postmenopausal women or men with Stage II (Stage IIA limited to a maximum of 1000 patients) or Stage III early invasive breast cancer. Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2-. Patients must have histologically confirmed hormone receptor positive (ER+ and/or PR+), HER2-, early invasive breast cancer. A formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be transmitted to a central sample repository and confirmation of receipt must be available prior to randomization.

    Objectives: To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC). To compare the following endpoints: iDFS excluding second primary cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS). To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone.

    NCT Registration ID (from clinicaltrials.gov): NCT02513394
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 25, 2017 Closing Date: November 30, 2018



    Closed to Accrual
    MA33 (TROG 0701)A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast
    Radiation treatment after surgery to remove the part of the breast that has DCIS within it improves the chances of not developing further cancer in that breast. For women who are considered to be at risk of recurrence in the breast after surgery, the standard treatment is radiation. This research project is testing whether improvements can be made to the radiation treatment.
    A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast

    Complexity Level: 2

    Eligibility: Women with DCIS, radial margins >1 mm post-breast conserving therapy.

    Objectives: Time of local recurrence Overall survival; disease-free survival; cosmetic outcome, acute and late toxicity; correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT00470236
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 29, 2009 Closing Date: June 20, 2014



    Closed to Accrual
    MA34 (BIG 4-11)A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer
    The aim of this study is to investigate a new drug called pertuzumab, which also acts on the HER2 marker but in a different way to trastuzumab. Pertuzumab is a research drug and is not yet licensed for HER2-positive breast cancer.
    A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer

    Complexity Level: 2

    Eligibility: Early breast cancer; HER2 positive centrally confirmed;, PS 0 -1, adequate bone marrow, liver, renal function; LVEF > 50%,blocks available for central collection. T1-4 any with N1 or T1c N0 or T1b NO if another high risk factor such as ER negative, age < 36 or Grade 3. The T1bN0 population will be limited to < 10% of the total population of 3806.

    Objectives: Primary: Disease Free Survival Secondary: Overall Survival; EFS; QoL; A biologic correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01358877
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 05, 2012 Closing Date: June 28, 2013



    Closed to Accrual
    MA32F (NSABP MA32F)Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer (NCIC CTG MA.32 Ancillary Study led by the National Surgical Adjuvant Breast and Bowel Project)
    Fatigue is a common problem after breast cancer treatments. Metformin, the medication being studied in MA.32, has few side effects, and is not expected to directly influence the recovery of energy after breast cancer treatment. Thus, this companion study is primarily being conducted to understand the recovery from treatment-related fatigue. Specifically, the companion study is being done to determine if there are markers in blood cells that can explain why some women have persistent fatigue after breast cancer treatments. Researchers also want to know if variations in genes that affect inflammation can determine which patients will experience ongoing fatigue after breast cancer treatment ends. In the companion study, researchers will do tests on blood cells to look for variations in these genes to see if women who continue to have fatigue after initial breast cancer treatment have a different pattern of gene activity than those who recover their energy.
    Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer (NCIC CTG MA.32 Ancillary Study led by the National Surgical Adjuvant Breast and Bowel Project)

    Complexity Level: 3

    Eligibility: - The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that confirms to federal and institutional guidelines for the MA32F Study before being enrolled. - The patient must be female and reside in the United States or Canada. - The patient must be english speaking. - Patient must be eligible for randomization in the MA32 treatment trial. - The patient must not have started taking MA32 study therapy. - The patient must have completed primary breast radiation therapy at least two weeks prior to enrollment in MA32F. The patient is considered ineligible if: - MA32 therapy has been initiated. - Patient currently receiving radiation therapy or additional radiation therapy is planned for initiation after starting MA32 study therapy.

    Objectives: - Determine the biological correlates of fatigue in breast cancer patients in the years following MA32 randomization and initiation of metformin or placebo. - Determine if specific SNPs in the promoter regions of IL-1 and IL-6 are associated with circulating markers of inflammation and fatigue in the years following MA32. - Determine which RNA gene expression pathways are associated with fatigue in metformin-treated patients and how do they relate to RNA gene expression pathways in untreated patients. - Determine the biological and behavorial predictors of fatigue in breast cancer patients in the years post-randomization. - Determine if metformin will be associated with reductions in inflammatory markers and corresponding decreases in fatigue.

    NCT Registration ID (from clinicaltrials.gov): NCT01286233
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 28, 2011 Closing Date: January 25, 2013



    Closed to Accrual
    MA38 (MA38)Randomized Phase II Study Comparing Two Different Schedules of Palbociclib plus Second Line Endocrine Therapy in Women with Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer

    Randomized Phase II Study Comparing Two Different Schedules of Palbociclib plus Second Line Endocrine Therapy in Women with Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. Confirmed diagnosis of ER positive breast cancer Postmenopausal status or pre/perimenopausal women suitable for ovarian suppressive therapy Progressed on prior endocrine therapy for advanced disease or within 12 months of adjuvant endocrine therapy Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease Eastern Cooperative Oncology Group [ECOG] 0-2 Adequate organ and marrow function

    Objectives: Primary: Progression Free Survival Secondary: Adverse Events, Safety and Tolerability, Response Rate (in patients with measurable disease), Duration of Response, Clinical Benefit Rate, Overall Survival, Patient Reported Quality of Life using EORTC QLQC 30 and trial specific checklist, population PK/PD markers of drug effect in a subgroup of patients on both arms

    NCT Registration ID (from clinicaltrials.gov): NCT02630693
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 16, 2015 Closing Date: February 10, 2017



    Closed to Accrual
    MAC5 (IBCSG 25-02)A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer
    This study is being done to compare the effects (good or bad) of exemestane given for 5 years, with tamoxifen given for 5 years. Side effects of these two treatments will also be studied. This research is being done because we do not know which of these treatments is better.
    A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer

    Complexity Level: 2

    Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy.

    Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue) plus exemestane compared with GnRH analogue plus tamoxifen for premenopausal women with steroid hormone receptor positive early invasive breast cancer. Patients may either receive no chemotherapy or commence chemotherapy at the same time that GnRH analogue is initiated

    NCT Registration ID (from clinicaltrials.gov): NCT00066703
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 07, 2003 Closing Date: March 11, 2011



    Closed to Accrual
    MAC14 (ECOG-ACRIN 2108)A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

    A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: 3.1 Registration (STEP 1) 3.1.1 Patients (male or female) must have an intact primary (not recurrent) invasive carcinoma of the breast. Biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast. 3.1.2 Patients with synchronous contralateral breast cancer are excluded. 3.1.3 Patients should have at least one site of distant metastatic disease. If only a single metastatic lesion is present, biopsy is mandatory. See Section 3.1.6. 3.1.4 Radiology reports documenting status of disease prior to initiation of systemic therapy must be available. Scans must have been completed within 4 weeks prior to start of systemic therapy. 3.1.5 If patient has only one site of metastatic disease, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available. Single metastatic lesion?

    Objectives: Primary Objectives To evaluate whether early local therapy of intact primary disease in women with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to women who receive local therapy for palliation only

    NCT Registration ID (from clinicaltrials.gov): NCT01242800
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: June 22, 2011 Closing Date: July 23, 2015



    Closed to Accrual
    MAC4 (IBCSG 24-02)A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer
    The purpose of this study is to see if shutting down the ovaries plus giving tamoxifen is better at preventing the return of breast cancer than just giving tamoxifen alone in premenopausal women. It will also test whether a newer hormone drug called exemestane plus suppression of the ovaries is better than tamoxifen plus suppression of the ovaries. In addition the side effects of these different treatments will be studied. This research is being done because we do not know which of these treatments is better.
    A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

    Complexity Level: 2

    Eligibility: Premenopausal women (estradiol (E2) levels in the premenopausal range) with histologically proven, resected breast cancer with ER and/or PR positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.

    Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by either long-term use of GnRH analogue or surgical oophorectomy or ovarian irradiation) plus tamoxifen compared with tamoxifen alone for premenopausal women with steroid hormone receptor positive early invasive breast cancer who either receive no adjuvant chemotherapy or remain premenopausal following adjuvant and/or neoadjuvant chemotherapy. In addition, the worth of exemestane will be evaluated for this premenopausal patient population by comparing ovarian function suppression plus exemestane with tamoxifen alone and by comparing ovarian function suppression plus exemestane with ovarian function suppression plus tamoxifen.

    NCT Registration ID (from clinicaltrials.gov): NCT00066690
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 07, 2003 Closing Date: April 30, 2010



    Closed to Accrual
    MAC9 (SWOG S0307)Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
    Histologically confirmed primary invasive adenocarcinoma of the breast, Stage I, II, III, with no evidence of metastatic disease
    Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

    Complexity Level: 2

    Eligibility: Patients must be women with histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) with no evidence of metastatic disease. Primary disease within the breast must be resected, either with mastectomy or breast sparing surgery. An axillary node evaluation should be performed per the standard of care specified at each institution.

    Objectives: To compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate. To compare the distributions of sites of first disease recurrence, adverse events and to correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients with these drugs.

    NCT Registration ID (from clinicaltrials.gov): NCT00127205
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 24, 2006 Closing Date: February 01, 2010



    Closed to Accrual
    MAC7 (SWOG S0226)Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
    The purpose of this study is to find out what effects (good or bad) the combination of hormonal agents anastrozole and fulvestrant have over anastrozole alone on the patient and their breast cancer.
    Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Post menopausal women with metastatic breast cancer

    Objectives: To compare time to tumour progression in post-menopausal women with metastatic breast cancer treated with anastrozole versus anastrozole and fluvestrant.

    NCT Registration ID (from clinicaltrials.gov): NCT00075764
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 23, 2006 Closing Date: July 01, 2009



    Closed to Accrual
    MAC15 (SWOG S1007)A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx For Positive Node, Endocrine Responsive Breast Cancer.

    A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx For Positive Node, Endocrine Responsive Breast Cancer.

    Complexity Level: 3

    Eligibility: Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status.

    Objectives: Primary: Disease Free Survival Secondary: Overall survival; EFS; Economic; QoL; A biologic correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01272037
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 05, 2011 Closing Date: October 15, 2015



    Closed to Accrual
    MAC13 (NCCTG N063D)Adjuvant, Lapatinib and/or Trastuzumab Treatment Optimisation Study A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer
    This purpose of this research study is to: o Find out what effects (good and bad) the study treatment has on you and your cancer. o Compare four different study treatment combinations to see if one is better o Find out what effects this study has on your quality of life. Because of recent research by NCCTG, the standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin?). However, not all patients with HER2+ breast cancer do better with trastuzumab, so investigators are trying to find out why. GW572016 (lapatinib, brand name: Tykerb?) is a new drug that is taken every day by mouth. Lapatinib is considered "investigational" in this study. "Investigational" means that the Health Canada has not approved lapatinib as a treatment for early breast cancer. This study is comparing trastuzumab to lapatinib and each drug alone to two combinations of trastuzumab and lapatinib.
    Adjuvant, Lapatinib and/or Trastuzumab Treatment Optimisation Study A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer

    Complexity Level: 2

    Eligibility: The target population for this trial are patients with non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer. They must have completed definitive surgery and received prior systemic (neo-) adjuvant anthracycline-based chemotherapy for primary breast cancer. In cases for which a taxane is indicated, it should be given concomitantly with the targeted therapy and after anthracycline-based chemotherapy. For patients in whom docetaxel is indicated, it must be given prior to targeted therapy. Patients should not have received any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa).

    Objectives: Progression free survival

    NCT Registration ID (from clinicaltrials.gov): NCT00490139
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 10, 2008 Closing Date: August 31, 2011



    Closed to Accrual
    MAC12 (ECOG PACCT-1)Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial

    Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial

    Complexity Level: 2

    Eligibility: Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment. ER and/or PR-positive Negative axillary nodes Tumor size 1.1-5.0cm (or 5mm-1.0cm) plus unfavorable histological features.

    Objectives: Primary: To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal. To create a tissue and specimen bank for patients enrolled in this trial. Secondary: To determine whether adjuvant hormonal therapy is sufficient treatment for women whose tumors meet established clinical guidelines. The primary study endpoint is disease-free survival; other co-primary endpoints include distant recurrence free interval, recurrence free interval, and overall survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00310180
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 21, 2006 Closing Date: October 06, 2010



    Closed to Accrual
    MAC11 (SWOG S0221)A Phase III Trial of Continuous Schedule AC + G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer.
    Patients must be women or men with histological confirmed diagnosis of operable Stage I, II, or III invasive breast cancer with known ER and PR status.
    A Phase III Trial of Continuous Schedule AC + G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer.

    Complexity Level: 2

    Eligibility: Patients must be women or men with histological confirmed diagnosis of operable Stage I, II, or III invasive breast cancer with known Estrogen and Progesterone status. Patients with T4 tumours are not eligible.

    Objectives: To compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 4 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel. To comapre the overall survival, toxic effects and to correlate outcome with putative prognostic markers in patients treated with these regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00070564
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: November 22, 2006 Closing Date: January 15, 2012



    Closed to Accrual
    MAC1 (CALGB 49907)A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer
    The purpose of this study is to compare the safety and effectiveness of adjuvant combination chemotherapy using cyclophosphamide plus methotrexate plus 5-fluorouracil (CMF), or doxorubicin (also called Adriamycin) plus cyclophosphamide (AC), compared to the chemotherapy drug capecitabine, in women 65 years of age and older. The study will also help gain more information about the effects of each of the treatments on physical and emotional well-being and how well the participants assigned to receive capecitabine follow the treatment plan. This research is being done because we do not know if receiving capecitabine will be better for women 65 years of age and older when compared with standard adjuvant drugs.
    A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer

    Complexity Level: 2

    Eligibility: Patients with operable, histologically confirmed adenocarcinoma of the female breast. TNM Stage must be T1-3, N1, M0, or T, N0, M0 if a primary lesion is > 3 cm. Patients must be 65 years of age or older, with a performance status of 0 - 2. Patients may have received up to 4 weeks of tamoxifen therapy for this malignancy and still be eligible. Patients who received tamoxifen or raloxifene for purposes of chemoprevention or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.

    Objectives: To compare the effectiveness of standard chemotherapy regimens (CMF or AC) with single agent capecitabine with respect to disease-free survival in women 65 years of age and older with local and regional breast cancer. To compare the effectiveness of standard chemotherapy regimens with capecitabine with respect to overall survival. To determine the effects of each treatment regimen on quality of life and physical function. To assess the toxicity of each treatment regimen and to study the adherence to an oral chemotherapy regimen in older patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00024102
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: May 28, 2002 Closing Date: December 29, 2006



    Closed to Accrual
    MA11A Phase I Study of Escalating Epirubicin and Cyclophosphamide in Combination with 5-Fu Using Granulocyte Colony Stimulating Factor Support in Premenopausal Women With Axillary Node Positive Operable Breast Cancer

    A Phase I Study of Escalating Epirubicin and Cyclophosphamide in Combination with 5-Fu Using Granulocyte Colony Stimulating Factor Support in Premenopausal Women With Axillary Node Positive Operable Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 30, 1993 Closing Date: August 24, 1995



    Permanently Closed
    MA12Double-Blind Randomized Trial of Tamoxifen versus Placebo in Patients with Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy

    Double-Blind Randomized Trial of Tamoxifen versus Placebo in Patients with Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): NCT00002542
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 1993 Closing Date: April 28, 2000



    Permanently Closed
    MA13 (9082)A Randomized, Comparative Study of High Dose CPA/cDDP/BCNU and ABMS versus Standard Dose CPA/cDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Operable Stage II or Stage II Breast Cancer Involving > 10 Axillary Lymph Nodes

    A Randomized, Comparative Study of High Dose CPA/cDDP/BCNU and ABMS versus Standard Dose CPA/cDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Operable Stage II or Stage II Breast Cancer Involving > 10 Axillary Lymph Nodes

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 10, 1993 Closing Date: May 29, 1998



    Permanently Closed
    MA15A Phase I/II Study of Docetaxel and Epirubicin as First Line Therapy for Metastatic Breast Cancer

    A Phase I/II Study of Docetaxel and Epirubicin as First Line Therapy for Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00002866
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 12, 1996 Closing Date: March 20, 2001



    Permanently Closed
    MA16A Randomized Comparative Trial of High-Dose Chemotherapy and Autologous Stem Cell Support versus Standard Therapy Following Response to Anthracycline- or Taxane-Based Chemotherapy in Women With Metastatic Breast Cancer

    A Randomized Comparative Trial of High-Dose Chemotherapy and Autologous Stem Cell Support versus Standard Therapy Following Response to Anthracycline- or Taxane-Based Chemotherapy in Women With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003032
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 25, 1997 Closing Date: June 18, 2001



    Permanently Closed
    MA17 (MA17)A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
    The purpose of this study is to find out whether it is better to receive letrozole or no further treatment after stopping tamoxifen. To do this, half of the patients in the study will receive letrozole and the other half will receive a placebo (a preparation with no active substance of medicinal value). Treatment with letrozole or placebo will begin within three months of tamoxifen being stopped.
    A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen

    Complexity Level: 2

    Eligibility: Post-menopausal women who had receptor-positive breast cancer, or unknown receptor status breast cancer, and have completed at least five years of adjuvant tamoxifen therapy.

    Objectives: To compare disease-free survival and overall survival. To compare incidence of contralateral breast cancer, and long-term clinical and laboratory safety. To evaluate overall quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00003140
    Participation: Open to centres in participating cooperative groups.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 24, 1998 Closing Date: September 04, 2002



    Permanently Closed
    MA17BThe Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen -- a Companion Study to MA.17
    The purpose of this optional part of the MA.17/JMA.17 research study, called a 'companion study', is to evaluate the effects of Letrozole / Placebo on the thinning of my bones (osteoporosis).
    The Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen -- a Companion Study to MA.17

    Eligibility: Eligible women will have a BMD T score greater than or equal to 2.0 SD below the mean value of peak bone mass in young normal women. They must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget?s disease, uncontrolled thyroid disease, Cushing?s disease, other pituitary diseases, or other bone diseases. Women must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time, any drug including bisphosphonates for the prevention of osteoporosis within the past six months, or long term use of coumarins.

    Objectives: To evaluate the effects of letrozole on bone mineral density in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to MA.17 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 26, 2000 Closing Date: August 30, 2002



    Permanently Closed
    MA27 (MA27)A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer
    The purpose of this study is to compare the ability of Exemestane and Anasrozole to prevent the recurrence of breast cancer and to compare their side effects. Every patient will receive one of these two drugs. This research is being done because there is still a risk of breast cancer returning after surgery. While current chemotherapy and hormone therapy (eg Tamoxifen) are useful, we want to improve the chance that the cancer will not return and we do not know which of the drugs is better.
    A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer

    Eligibility: Post-menopausal women who have histologically or cytologically confirmed, receptor-positive, adequately excised, primary breast cancer are eligible for this trial. Adjuvant chemotherapy and radiation are allowable. Chemotherapy must be completed before randomization. Radiotherapy may be given prior to or concurrently with protocol therapy.

    Objectives: To compare event free survival (EFS) between women treated with Exemestane or Anastrozole as adjuvant therapy. To compare the incidence of contralateral breast cancer, the time to distant recurrence, survival & safety among treatment groups.

    NCT Registration ID (from clinicaltrials.gov): NCT00066573
    Participation: NCIC CTG, CTSU sites, IBCSG
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 02, 2003 Closing Date: July 31, 2008



    Permanently Closed
    MA19A Phase III Study of DPPE (BMS-217380-01) Combined With Doxorubicin versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer

    A Phase III Study of DPPE (BMS-217380-01) Combined With Doxorubicin versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 09, 1998 Closing Date: July 08, 1999



    Permanently Closed
    MA10 (10921)A Multicentre Randomized Study of Dose-Intensive Chemotherapy as Primary Treatment in a Multimodality Approach for Locally Advanced/Inflammatory Breast Cancer (EORTC - NCIC CTG - SAKK Study)

    A Multicentre Randomized Study of Dose-Intensive Chemotherapy as Primary Treatment in a Multimodality Approach for Locally Advanced/Inflammatory Breast Cancer (EORTC - NCIC CTG - SAKK Study)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 13, 1993 Closing Date: April 02, 1996



    Permanently Closed
    MA23 (10951)Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients
    The purpose of this study is to compare the effects on a group of patients who have a similar stage of breast cancer of a new drug exemestane compared to tamoxifen. This research is being done because exemestane has been shown to be effective in controlling tumour growth, but it is not clear if it can offer better results than standard treatment with tamoxifen.
    Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients

    Eligibility: Postmenopausal patients with locally recurrent inoperable or metastatic carcinoma of the breast. Patients must have had histologically or cytologically confirmed adenocarcinoma of the breast at original diagnosis. At study entry the patient must have had metastatic progressive or locally recurrent inoperative breast cancer. Patients must have positive estrogen or progesterone receptor status at the time of original diagnosis or subsequently at a metastatic site.

    Objectives: To determine if a hormonal therapy with exemestane is superior in terms of progression-free survival to tamoxifen in first line advanced breast cancer. To further document the safety profile of exemestane and to compare overall survival between the treatment arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00002777
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 08, 2001 Closing Date: September 20, 2002



    Permanently Closed
    MA8A Phase III Comparative Study of Vinorelbine Combined With Doxorubicin versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer

    A Phase III Comparative Study of Vinorelbine Combined With Doxorubicin versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 15, 1992 Closing Date: July 17, 1995



    Permanently Closed
    MA9C (8854)Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients

    Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1996 Closing Date: October 01, 1998



    Permanently Closed
    MA6APhase I Study of Fluorouracil, Doxorubicin and Vinorelbine (FAN) in Patients With Advanced Breast Cancer

    Phase I Study of Fluorouracil, Doxorubicin and Vinorelbine (FAN) in Patients With Advanced Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 06, 1992 Closing Date: July 07, 1994



    Permanently Closed
    MAX1 (QMUL LATTE)Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE)
    The ATAC trial gathered valuable data on the use of aromatase inhibitors in the adjuvant setting. This study followed patients for an average of 10 years. The LATTE Study proposes to collect further follow-up information on as many eligible participants as possible who were randomized to receive either tamoxifen or anastrozole. The Latte study will collect data about local and distant recurrences, the development of new cancers, survival, and other major cardiac and cerebrovascular events.
    Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE)

    Complexity Level: 3

    Eligibility: Patients must satisfy the following criteria to be eligible for entry into this study: patients randomised to one of the monotherapy arms in the ATAC Trial alive at 10 years follow-up

    Objectives: Primary objectives The primary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment + 5 years follow-up) as adjuvant therapy in terms of: Time to recurrence of breast cancer in the post 10 year period (defined as the earliest of local or distant recurrence, new primary breast cancer, or death) Death after recurrence Secondary objectives The secondary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment) as adjuvant therapy in terms of: Time to distant recurrence Cancer-specific survival New breast primaries Other cancers Ischaemic cardiac and cerebrovascular events Hip (and other) fractures

    NCT Registration ID (from clinicaltrials.gov): NCT01745289
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2016 Closing Date: January 21, 2019



    Permanently Closed
    MAC4C (IBCSG ANZ0701)Investigating Cognitive Function For Patients Participating In The SOFT Trial In Selected Centers
    The purpose of this substudy is to compare the effects (good and bad) of blocking the ovaries and taking tamoxifen with tamoxifen alone on cognitive function (memory and thinking). This substudy will also compare the effects (good and bad) of tamoxifen and blocking the ovaries with exemestane and blocking the ovaries on cognitive function.
    Investigating Cognitive Function For Patients Participating In The SOFT Trial In Selected Centers

    Complexity Level: 3

    Eligibility: - Patient registered for the parent SOFT study but not yet started protocol hormonal therapy. - Patient has not yet received any adjuvant endocrine therapy (i.e. no tamoxifen, exemestane, GnRH agonist, bilateral oophorectomy, ovarian irradiation), either before or after registration on the SOFT trial. Patients who have commenced adjuvant endocrine therapy prior to registration on the parent SOFT protocol are not eligible for this sub-study. - Patient can speak and read the local language(s) fluently. - Written informed consent must be obtained. The informed consent must be kept in the patient?s records at the participating site and be available for monitoring, auditing, and Health Authority inspection.

    Objectives: The primary objective is to evaluate and compare changes in cognitive function over 1 year in premenopausal BC patients who receive adjuvant tamoxifen (T) with or without ovarian function suppression (OFS). We hypothesise that women who receive T + OFS will show greater deterioration in cognitive function than those who receive T alone.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 09, 2008 Closing Date: April 30, 2010



    Permanently Closed
    MA2Pilot Study of Sequential Hormono-Chemotherapy in Metastatic Breast Carcinoma

    Pilot Study of Sequential Hormono-Chemotherapy in Metastatic Breast Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 04, 1981 Closing Date: August 20, 1982



    Permanently Closed
    MA1NCIC Cooperative Clinical Trial of Tamoxifen versus Ovarian Ablation in the Treatment of Metastatic Breast Carcinoma in Premenopausal Women

    NCIC Cooperative Clinical Trial of Tamoxifen versus Ovarian Ablation in the Treatment of Metastatic Breast Carcinoma in Premenopausal Women

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 06, 1981 Closing Date: May 30, 1983



    Permanently Closed
    MAC6 (26-02)A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer who Receive Endocrine Therapy

    A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer who Receive Endocrine Therapy

    Complexity Level: 2

    Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors for whom there is an uncertain role for adding chemotherapy to the adjuvant treatment program. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy.

    Objectives: This trial will evaluate the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy will be determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane will be determined by the investigator.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 04, 2003 Closing Date: November 22, 2005



    Permanently Closed
    MA7APhase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer

    Phase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 10, 1992 Closing Date: May 24, 1994



    Permanently Closed
    MA14A Randomized Trial of Antiestrogen Therapy versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women

    A Randomized Trial of Antiestrogen Therapy versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women

    NCT Registration ID (from clinicaltrials.gov): NCT00002864
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 24, 1996 Closing Date: July 21, 2000



    Permanently Closed
    MAP3BThe Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer - A Companion Study to MAP.3

    The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer - A Companion Study to MAP.3

    Complexity Level: 3

    Eligibility: Woman randomized to MAP.3 with: a BMD of Spine (L1-L4)or Total Hip and Femoral Neck, T score >= -1.9 sd are eligible for this study.

    Objectives: To examine whether there is clinically relevant difference in impact on BMD between exemestane and placebo after two years from randomization to the core protocol.

    NCT Registration ID (from clinicaltrials.gov): NCT00688246
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 23, 2008 Closing Date: March 23, 2010



    Permanently Closed
    MAP3A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
    After menopause when the ovaries stop making estrogen the body continues to make estrogen from skin, muscle and fat. Even though it is only present at low levels it continues to be very important in the development of breast cancer. A new drug, called exemestane, stops the supply of estrogen to pre-cancerous and cancerous cells and helps to prevent them from growing.
    A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

    Complexity Level: 3

    Eligibility: Postmenopausal women at increased risk for the development of breast cancer are eligible for this study

    Objectives: To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo

    NCT Registration ID (from clinicaltrials.gov): NCT00083174
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 11, 2004 Closing Date: March 23, 2010



    Permanently Closed
    MAP2A Randomized Study of the Effect of Exemestane (Aromasin) versus Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer

    A Randomized Study of the Effect of Exemestane (Aromasin) versus Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer

    Eligibility: Healthy, postmenopausal women who have increased radiological density occupying >25% of the breast tissue on routine screening mammogram.

    Objectives: To determine whether treatment with exemestane for one year in women with spontaneously increased breast density leads to a decrease in breast density of at least >1 grade 12 months after randomization; to determine if the decrease in breast density grade is sustained one year after stopping treatment; to determine the correlation between the grade of breast density and bone density at base line and at 12 months; to assess overall safety (bone and lipid metabolism, toxicity); to compare menopause-specific quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00066586
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 2001 Closing Date: June 09, 2006



    Permanently Closed
    MAP1A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density

    A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density

    Eligibility: Healthy, postmenopausal women or those postmenopausal women who have had prior breast cancer with a receptor positive tumour, either ER or PR or equivocal or unknown breast cancer or who have had prior DCIS (receptor status not required), who have either not had adjuvant endocrine therapy or are more than six months from the completion of adjuvant endocrine therapy and who are eligible by virtue of the appearance of increased radiological density, grade 4, 5 or 6, on routine mammographic screening

    Objectives: To determine the proportion of women who have a decrease in breast density of at least one grade after treatment for one year; to determine if the decrease in density grade is sustained one year after cessation of therapy; to evaluate specific changes related to other end-organ effects i.e. bone density, lipid metabolism, etc.

    NCT Registration ID (from clinicaltrials.gov): NCT00238316
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 05, 2000 Closing Date: June 09, 2006



    Permanently Closed
    MAC8 (NSABP B-37)A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer.

    A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer.

    Complexity Level: 2

    Eligibility: Histologically proven local &/or regional recurrence of invasive breast cancer following primary treatment with mastectomy or breast conserving treatment. Surgical resection with radiotherapy (ro) or (ri). No evidence of distant mets. Measurement of hormone receptors in the recurrent tumour. Medically suitable for chemo of 3-6 months. Completed baseline QOL. Informed consent and agree to data and material transfer. Geographically accessible for f/u.

    Objectives: Primary: To determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer. Secondary: To determine systemic disease-free and overall survival; sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer; and to determine the quality of life of patients treated with this regimen.

    NCT Registration ID (from clinicaltrials.gov): NCT00074152
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 11, 2005 Closing Date: November 30, 2007



    Permanently Closed
    MAC3 (E2100)A Randomized Phase III Trial of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.
    The purpose of this study is to compare the effects (good or bad) of paclitaxel in combination with bevacizumab, the study drug, or paclitaxel alone in patients with breast cancer that has spread. This research is being done because current therapy does not help everyone with breast cancer that has spread or recurred. Cancers set off the growth of new blood vessels in order to continue to grow. This process is called "angiogenesis". New drugs such as bevacizumab may treat cancers by blocking these new blood vessels from growing in the tumour.
    A Randomized Phase III Trial of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.

    Eligibility: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast with measurable or nonmeasurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent. All scans or x-rays used to document measurable or nonmeasurable disease must be done within 4 weeks prior to randomization. Patients with breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin. HER-2 testing is strongly encouraged. Therefore patients with unknown HER-2 status are not eligible unless the treating physician has determined that Herceptin-based therapy would be inappropriate or not indicated. Patients must not have had prior chemotherapy for locally recurrent or metastatic breast cancer. Prior hormonal therapy for locally recurrent or metastatic disease is allowed, but this must have been discontinued

    Objectives: To determine the time to treatment failure of patients with chemotherapy naive metastatic breast cancer randomized to treatment with either paclitaxel alone or paclitaxel plus bevacizumab. To compare the objective response rate, duration of response, overall survival and time to progression of paclitaxel to that of the combination of paclitaxel plus bevacizumab. To compare the toxicity of paclitaxel to that of paclitaxel in combination with bevacizumab. To compare the quality of life (FACT-B) of patients treated with paclitaxel to that of the combination of paclitaxel plus bevacizumab as first-line therapy for metastatic breast cancer. To compare changes in surrogate markers of angiogenesis and response including VEGF and VCAM-1 expression during treatment with paclitaxel to that of paclitaxel plus bevacizumab.

    NCT Registration ID (from clinicaltrials.gov): NCT00028990
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 26, 2002 Closing Date: May 26, 2004



    Permanently Closed
    MAC2 (B-33)A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy (NSABP: B-33).

    A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy (NSABP: B-33).

    NCT Registration ID (from clinicaltrials.gov): NCT00016432
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 03, 2002 Closing Date: October 09, 2003



    Permanently Closed
    MA9 (8814)Phase III Comparison of Adjuvant Chemoendocrine Therapy with CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients with Involved Axillary Lymph Nodes and Positive Receptors

    Phase III Comparison of Adjuvant Chemoendocrine Therapy with CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients with Involved Axillary Lymph Nodes and Positive Receptors

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 21, 1991 Closing Date: July 31, 1995



    Permanently Closed
    MA5Cooperative Clinical Trial of Intensive CEF versus Standard CMF as Adjuvant Therapy for Breast Carcinoma in Premenopausal Patients With Histologically Involved Axillary Nodes

    Cooperative Clinical Trial of Intensive CEF versus Standard CMF as Adjuvant Therapy for Breast Carcinoma in Premenopausal Patients With Histologically Involved Axillary Nodes

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1989 Closing Date: July 30, 1993



    Permanently Closed
    MA4National Cancer Institute Of Canada Cooperative Clinical Trial Of Adjuvant Post-Surgical Treatment Of Breast Carcinoma In Post-Menopausal Patients With Histologically Involved Axillary Nodes

    National Cancer Institute Of Canada Cooperative Clinical Trial Of Adjuvant Post-Surgical Treatment Of Breast Carcinoma In Post-Menopausal Patients With Histologically Involved Axillary Nodes

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 13, 1984 Closing Date: December 31, 1990



    Permanently Closed
    MA31A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer
    This is a study for women with documented HER2/neu positive breast cancer which is metastatic and with no prior chemotherapy and/or anti-HER2/neu targeted therapy in the metastatic setting. HER2/neu status must be confirmed prior to randomization using either a local or the central laboratory [CTAG at the BCCA, Vancouver, Canada]. Eligible women will be assigned (open label) to one of two arms: ARM 1 - Taxane chemotherapy plus lapatinib; ARM 2 - Taxane chemotherapy plus trastuzumab. Taxane chemotherapy will include either q weekly paclitaxel or q 3-weekly docetaxel. The choice of taxane will be up to the treating physician and must be specified at the time of randomization. Patients on arm 1 will receive oral daily lapatinib concurrently with the chosen taxane for 24 weeks, and single-agent daily lapatinib thereafter, until PD. Patients on arm 2 will receive IV trastuzumab concurrently with the chosen taxane for 24 weeks, and single agent 3-weekly trastuzumab thereafter until PD.
    A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Women with documented evidence of HER2/neu positive breast cancer (by local or central laboratory testing) which is metastatic, and with no prior chemotherapy and/or anti-HER2/neu targeted therapy in the metastatic setting.

    Objectives: Primary - Progression-Free Survival Secondary - Overall Survival - Time to CNS metastases at the time of progression - Incidence rates of CNS metastases at the time of progression - Overall objective response rate, time to response and duration of response - Clinical benefit response rate - Adverse event profile - Quality of Life (using the EORTC QLQ-C30 and a Trial Specific Checklist) - Clinical outcomes using biomarker changes in biological samples - Economic Evaluation: health utilities (using the EQ-5D questionnaire) and healthcare utilization

    NCT Registration ID (from clinicaltrials.gov): NCT00667251
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 17, 2008 Closing Date: December 01, 2011



    Permanently Closed
    MA29 (MA29)A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.
    The purpose of this study is to investigate the effects of sunitinib when given to women with locally-advanced, operable breast cancer, prior to surgery. This study is being done because researchers are trying to get a better understanding of exactly how sunitinib works and how it affects the formation of blood vessels on breast tumours.
    A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.

    Eligibility: Women with newly diagnosed, histopathologically confirmed, T1c, T2 or T3 unifocal, operable, carcinoma of the breast (prior to surgery).

    Objectives: PRIMARY: To assess the feasibility of administering oral sunitinib pre-operatively, to patients with newly diagnosed, histopathologically confirmed T1c, T2 or T3 unifocal, operable carcinoma of the breast. SECONDARY: - toxicity - tumour response (RECIST) - pharmacodynamic endpoints [treatment-induced changes (1) in the levels of tumour and plasma-soluble markers of angiogenesis, (2) in the protein/RNA levels of host and tumour-specific genes involved in response and toxicity to sunitinib, (3) on vascular parameters (DCE-MRI), (4) on cell death and tumour microcirculation (spectroscopic and microbubble contrast-enhanced ultrasound) and (5) on tumour metabolic activity (18-FDG-PET)] - tumour banking (optional)

    NCT Registration ID (from clinicaltrials.gov): NCT00482755
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 12, 2007 Closing Date: March 15, 2010



    Permanently Closed
    MA28 (NCCTG N9831)Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment For Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer
    The purpose of this study is to see if the addition of Herceptin to standard chemotherapy drugs (Adriamycin, Cytoxan and Taxol) is beneficial for women with node positive breast cancer whose tumors have an excess amount of HER-2 gene. Herceptin is an antibody that attacks cancer cells and may be able to control tumor growth.
    Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment For Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer

    Complexity Level: 2

    Eligibility: Operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes. Operable, histologically confirmed adenocarcinoma of the female breast and negative lymph nodes. =84 days from mastectomy or =84 days from axillary dissection or sentinel node detection if the patient's most extensive breast surgery was a breast sparing procedure. (This timing is per a decision by the Breast Intergroup.) TAM therapy =18 years of age with any menopausal status. Adequate bone marrow function. Adequate hepatic function Left ventricular ejection fraction (LVEF) within institutional normal range. If LVEF is > 75%, the investigator should consider performing a second review of the MUGA/echocardiogram or performing a repeat MUGA/echocardiogram prior to registration. Such re-reviews or repeat MUGA/echocardiogram are not permitted after registration

    Objectives: To compare the combination AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of disease-free survival (DFS). To compare the combination of AC followed by weekly paclitaxel with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of DFS. To compare the sequential schedule of AC, weekly paclitaxel, and trastuzumab with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of DFS. To compare the cardiotoxicities of 1) AC followed by weekly paclitaxel, 2) AC followed by weekly paclitaxel followed by weekly trastuzumab, and 3) AC followed by weekly paclitaxel and trastuzumab followed by weekly trastuzumab To compare the combination of AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of overall survival (OS).

    NCT Registration ID (from clinicaltrials.gov): NCT00005970
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed Closing Date: April 25, 2005



    Permanently Closed
    MA27D (N0434)The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27
    The purpose of this study is to look at changes in breast density before and after the therapy you will get in the MA.27 study. "Breast density" is the proportion of the breast that is made up of white or dense tissue and higher breast density is associated with breast cancer. The researchers want to understand if there are changes in breast density with MA.27 study therapy, whether these changes are linked to changes in hormones or drug levels in your blood and whether these changes are influenced by hereditary factors. The study will also examine whether changes in breast density help predict whether or not breast cancer will come back or if it will occur in the other breast
    The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27

    Eligibility: MA.27 patients with one intact non-cancerous breast with no hormone, SERM or GnRHA therapy within the past 12 months and no hormone, SERM or GnRHA therapy within 6 months prior to the pre-registration mammogram are eligible for this companion study to MA.27

    Objectives: To assess the change in percent breast density and change in dense area in response to aromatase inhibitor therapy, whether these changes correlate with changes in plasma hormones and whether these changes, over time, are associated with recurrence of breast cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00316836
    Participation: Limited to MA.27 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 2006 Closing Date: July 31, 2008



    Permanently Closed
    MA27B (MA.27B)The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27
    After menopause, the strength of the bones slowly declines. One of the reasons it declines is because estrogen levels have also declined. The purpose of this "companion study" is to evaluate the possible additional effects of anastrozole or exemestane on the thinning of bones (osteoporosis). Bone "density" will be measured prior to MA.27 treatment and annually while on MA.27 study treatment
    The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27

    Eligibility: MA.27 patients who have a bone mineral density measurement (using DEXA: dual energy x-ray absorptiometry) done within 12 weeks prior to randomization to the MA.27 core protocol may participate in the companion protocol. In order to be eligible patients must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget's disease, uncontrolled thyroid disease, Cushing's disease, other pituitary diseases, or other bone diseases. Patients must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time or be on long term treatment with coumarins

    Objectives: The primary objective is to examine whether there is a clinically relevant difference in impact on BMD between the steroidal (exemestane) and the non-steroidal (anastrozole) agents at 2 years

    NCT Registration ID (from clinicaltrials.gov): NCT00354302
    Participation: Limited to MA.27 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 2006 Closing Date: May 30, 2008



    Permanently Closed
    MA17LThe Influence of Letrozole on Serum Lipid Concentrations in Women with Primary Breast Cancer Who Have Completed Five Years of Adjuvant Tamoxifen -- A Companion Study to MA.17
    The purpose of this optional part of the MA.17 study, called a 'companion study', is to evaluate the effects of Letrozole / Placebo on the levels of certain fats in the blood. The collection of extra blood samples to look at changes in fat levels in the blood is an important but optional part of the MA.17 study in North America.
    The Influence of Letrozole on Serum Lipid Concentrations in Women with Primary Breast Cancer Who Have Completed Five Years of Adjuvant Tamoxifen -- A Companion Study to MA.17

    Eligibility: MA.17 patients, who are non-hyperlipidemic and not taking lipid lowering agents.

    Objectives: To evaluate the effects of letrozole on serum lipid parameters in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to MA.17 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 09, 1999 Closing Date: May 02, 2002



    Permanently Closed
    MA17R (MA17R)A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study)
    The purpose of this follow-up study to the original MA.17 trial is to see if taking an aromatase inhibitor for more than five years is better than taking it for just 5 years. At the present time 5 years of treatment with an aromatase inhibitor is considered the standard of care. It is not known if additional treatment will add further benefit. Also long term side effects may occur while on an aromatase inhibitor and these could outweigh any benefits of continuing treatment. To find out if aromatase inhibitor therapy should be continued beyond five years, half of the patients in the study, after completing the initial five years of aromatase inhibitor therapy, will receive an additional five years of letrozole and the other half will receive placebo (a preparation with no active substance of medicinal value). Treatment with letrozole or placebo will begin as soon as possible and no later than two years after completing the first five years of aromatase inhibitor therapy.
    A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study)

    Complexity Level: 2

    Eligibility: Women completing around five years of aromatase inhibitor therapy, either as initial therapy or after tamoxifen, including those who received letrozole within the MA.17 study, are eligible for randomization to a further five years of letrozole or placebo. Eligible subjects must be free of recurrent breast cancer and have completed the five years of aromatase inhibitor therapy no more than 2 years prior to randomization. BMD measured by DEXA should be done within 4 weeks prior to randomization if not done within the previous 12 months, but the results do not affect eligibility.

    Objectives: To compare the disease-free survival of subjects who receive 5 years of letrozole or placebo after having received around 5 years (4.5 - 6) of aromatase inhibitor therapy (letrozole, anastrozole, or exemestane) including those who received 5 years of adjuvant letrozole as part of the MA.17 trial. To evaluate the effect on overall (all cause specific) mortality. To evaluate the incidence of contralateral breast cancer. To evaluate the long term clinicial and laboratory safety of aromatase inhibitor therapy which includes 5 years of letrozole therapy. To evaluate overall quality of life (SF-36) and menopausal specific QOL (Menqol). To test the hypothesis that common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for the aromatase inhibitor letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT00754845
    Participation: Open to centres in participating cooperative groups.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 14, 2004 Closing Date: May 08, 2009



    Permanently Closed
    MA20A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
    The purpose of the study is to find out whether it is better to receive breast radiation or the breast radiation plus radiation to the surrounding lymph glands or nodes (regional radiation). This will determine if regional radiation will prevent distant spread of the cancer and cause women to live longer by keeping the cancer from coming back.
    A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

    Complexity Level: 2

    Eligibility: Pre or post menopausal women with node positive and high risk node-negative breast cancer treated by breast conserving therapy and currently accepted adjuvant chemotherapy and/or hormonal therapy.

    Objectives: To determine if regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) in addition to breast radiation prolongs survival in women with early breast cancer compared with breast radiation alone. To compare disease free survival, isolated local regional disease-free survival, and distant disease free survival. To evaluate toxicity. To evaluate quality of life. To determine the cosmetic outcome of these two treatment approaches.

    NCT Registration ID (from clinicaltrials.gov): NCT00005957
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 1999 Closing Date: February 02, 2007



    Permanently Closed
    MA21 (MA21)A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer
    The purpose of this study is to compare the effects (on you and your breast cancer) of three different combinations of drugs which are commonly used to treat this disease. If you are randomized to Group 1 you will receive three commonly-used chemotherapy drugs called cyclophosphamide, epirubicin and 5 fluorouracil. If you are randomized to Group 2 you will receive three commonly-used chemotherapy drugs called cyclophosphamide, epirubicin and paclitaxel. If you are randomized to Group 3 you will receive three commonly-used chemotherapy drugs called doxorubicin, cyclophosphamide and paclitaxel. This research is being done because currently we do not know which of these three combinations of drugs is better than the others.
    A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer

    Complexity Level: 2

    Eligibility: Women with histologically confirmed adenocarcinoma of the breast treated with either total or partial mastectomy; node positive or high risk node negative; T0-T4, N0, N1, or N2, M0; ER status must be known; < 60 years of age; no prior chemotherapy, hormonal therapy, immunotherapy or radiotherapy for breast cancer; adequate blood counts; ECOG < 2; LVEF > institutional lower normal limit; no history of cardiac disease.

    Objectives: To compare disease-free survival and overall survival among the three treatment arms. To compare rate of toxicities and quality of life among the three treatment arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00014222
    Participation: Not Limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 04, 2000 Closing Date: April 29, 2005



    Permanently Closed
    MA22A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer
    The purpose of this study is to find out what effect these drugs (epirubicin and docetaxel) have on and to find a more effective treatment for this type of breast cancer. It is thought that the two drugs, epirubicin and docetaxel when given together may be effective in shrinking tumours. This study will evaluate the safety and effectiveness of docetaxel and epirubicin when they are given together.
    A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer

    Complexity Level: 2

    Eligibility: To determine MTD and recommended phase II dose of docetaxel and epirubicin with pegfilgrastim in a phase I dose escalation study as 1st line therapy. To evaluate toxicity of the combination at the recommended phase II dose. To evaluate response rate and duration of the combination as first-line therapy at the recommended phase II dose.

    Objectives: Women with locally advanced or inflammatory breast cancer; no previous surgical systemic or radiation treatment for breast cancer other than biopsy for diagnosis; ECOG 0, 1, 2; adequate blood counts; LVEF > institutional lower normal limit; no history of cardiac disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00066443
    Participation: Limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 25, 2003 Closing Date: June 08, 2009



    Permanently Closed
    MA24 (BIG B016348)A Randomized Three-Arm Multi-Centre Comparison of 1 Year and 2 Years of Herceptin versus no Herceptin in Women With HER2-positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

    A Randomized Three-Arm Multi-Centre Comparison of 1 Year and 2 Years of Herceptin versus no Herceptin in Women With HER2-positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: Women with primary breast cancer that over-expresses HER2 (determined by IHC 3+ or FISH positive) who have completed (neo-) adjuvant systemic chemotherapy and radiotherapy, if applicable.

    Objectives: To compare disease-free survival (DFS) in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin? for one year versus no Herceptin?. To compare DFS in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin? for two years versus no Herceptin?.

    NCT Registration ID (from clinicaltrials.gov): NCT00045032
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 07, 2002 Closing Date: April 05, 2004



    Permanently Closed
    MA25 (S9927)Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes
    The purpose of this study is to find out if it is better or not to receive radiotherapy treatment after chemotherapy. To do this half of the patients in this study will get radiation therapy after chemotherapy and the other half will be watched closely but receive no radiotherapy treatment. This research is being done because we do not know whether radiotherapy treatment is better for this type of breast cancer than no further treatment.
    Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes

    Eligibility: Women with histologically confirmed adenocarcinoma of the breast, with the primary tumour < 5 cm and 1-3 postive axillary nodes (pathologic T1-2, pathologic N1). Patients with apocrine, adenocystic, or squamous carcinomas or sarcomas of the breast or bilateral breast cancer are not eligible.

    Objectives: To compare overall and disease-free survival in pre- and post-menopausal women with Stage II breast cancer and 1 ? 3 positive nodes treated with or without radiation therapy following mastectomy and adjuvant chemotherapy. To assess local-regional control for this cohort of patients. To assess the potential toxicities of radiotherapy delivered using CT-directed treatment in this cohort of patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00005983
    Participation: Limited to centres with current CPA/FWA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 2001 Closing Date: June 15, 2003



    Permanently Closed

    Gastro-intestinal

    IDStudy TitleStatus
    CRC9 (NRG-GI005)Phase II/III Study of Circulating Tumor DNA as a Predictive Marker for Response to Adjuvant Chemotherapy in Patients with Stage II Colon Cancer

    Phase II/III Study of Circulating Tumor DNA as a Predictive Marker for Response to Adjuvant Chemotherapy in Patients with Stage II Colon Cancer

    Complexity Level: 3

    Eligibility: Patients must 1) have histologically/pathologically confirmed stage 2A adenocarcinoma of colon with at least 12 LNs examined at resection 2) be appropriate for active surveillance 3) distal extent of tumor must be 12cm from the anal verge 4) complete gross tumor resection (curative resection) within 14-60 d of randomization 5) adequate tumor for testing 6) adequate hematologic-hepatic-renal function within 28 d before randomization 7) ECOG 0 or 1 8) only adenocarcinoma colon cancer histology 9) no metastatic disease 10) no tumor-related bowel perforation, history of prior invasive colon malignancy or organ transplantation 11) no prior systemic chemo, targeted therapy, IO, or RT for CRC 12) no other invasive malignancy & no antineoplastic therapy within 5 yrs before randomization 13) no uncontrolled cardiac disease 14) no sensory or motor neuropathy gr 2, active uncontrolled seizure disorder, active or chronic infection requiring systemic therapy, known homozygous DPD deficiency

    Objectives: PRIMARY OBJECTIVE (PH 2) - To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer PRIMARY OBJECTIVE (PH 3) - To compare RFS in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer SECONDARY OBJECTIVES - in patients with stage IIA colon cancer: - To describe the prevalence of detectable ctDNA following surgical resection - To estimate time-to-event outcomes (OS, RFS, TTR) by ctDNA marker status & treatment - To estimate the rate of compliance with adjuvant chemotherapy &/or active surveillance EXPLORATORY OBJECTIVES: - To describe the association of quantitative ctDNA levels with time to event outcomes (RFS, OS, & TTR) - To characterize genomic profiles associated with recurrence using a ctDNA assay - To model the cost effectiveness of the use of ctDNA vs SOC in this setting

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    CO21A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients with High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE).
    The purpose of this study is to compare the disease-free survival of patients involved in a physical activity program (designed to increase physical activity participation) who also receive general health education materials (about diet and physical activity) to patients who receive the general health education materials only. This study is being done because, as of yet, there is no conclusive evidence that physical activity will decrease the likelihood of colon cancer recurrence. This study will also obtain important information about the impact of physical activity on patients' physical functioning, body composition, quality of life, fatigue, mood, cytokines and the insulin pathway, and their influence on prognosis, as well as cost-effectiveness.
    A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients with High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE).

    Complexity Level: 3

    Eligibility: Medically fit colon cancer patients (high risk stage II and stage III) who have completed adjuvant chemotherapy within the past 60-180 days. Current physical activity levels must not meet the recommended guidelines (>=150 minutes of moderate-to-vigorous or >=75 minutes of vigorous exercise/week). Following registration, and prior to randomization, patients must successfully complete at least two stages of a submaximal exercise test to ensure they are able to safely exercise at a moderate to vigorous intensity.

    Objectives: Primary Objective: Disease free survival (DFS) Secondary objectives: 1. To compare the two intervention arms with respect to: - Quality of Life (QOL) - Objective markers of physical fitness - Physical activity behaviour - Overall survival (OS) - Serum levels of insulin, IGF-1, IGF-2 and IGFBP3 - Cytokine levels - Economic evaluations including cost effective and cost-utility analyses - Predictors of physical activity adherence 2. To compare the following evaluations in all randomized patients to assess for potential associations - Molecular markers with DFS, OS, level of physical activity and level of fatigue - Age, gender, country, incremental increase in physical activity and change in aerobic fitness with DFS, OS, level of fatigue and QOL 3. To establish a comprehensive specimen bank linked to a clinical database for the further study of molecular markers in colon cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00819208
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Open to Accrual
    Activation Date: December 03, 2008



    Open to Accrual
    CO27 (IROCAS)A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting
    The purpose of this study is to find out whether standard treatment with mFOLFOX (combination of 3 drugs: 5-fluorouricil, leucovorin, and oxaliplatin) or a different combination treatment called mFOLFIRINOX (combination of 4 drugs: 5-fluorouricil, leucovorin, irinotecan and oxaliplatin) is better at preventing high-risk stage III colon cancer that has been surgically removed from coming back. To do this, half of the patients in this study will get mFOLFOX and the other half will receive mFOLFIRINOX. You will know what treatment you will get and both treatments last approximately 6 months.
    A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting

    Complexity Level: 2

    Eligibility: Inclusion: Adults with pathologically confirmed high-risk stage III colon adenocarcinoma, who have undergone curative R0 surgical resection within 42 days before randomization. No prior abdominal/pelvic radiotherapy and no prior chemotherapy; adequate hematologic function; adequate liver function (bilirubin > 1.5 xUNL), Creatinine clearance > 50 mL/min; patient information and signed informed consent. Exclusions: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start; metastatic disease; IBS; known hypersensitivity to any of study drugs; clinically relevant CAD or history of MI in last year or uncontrolled arrhythmia; previous malignancy; known DPD deficiency or UGTA1A1 homozygous 7/7.

    Objectives: Primary Objective: 3 year Disease Free Survival (DFS) Secondary Objectives: 2 year DFS, Overall Survival, safety of study treatment

    NCT Registration ID (from clinicaltrials.gov): NCT02967289
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: May 02, 2017



    Open to Accrual
    CO28NEOadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The NEO Trial
    This is a two staged, single arm phase II trial seeking to rectal organ preservation in patients with early rectal cancer treated with neo-adjuvant chemotherapy FOLFOX or CAPOX followed by Transanal Endoscopic Microsurgery (TEMS) or Transanal Minimally Invasive Surgery (TAMIS).
    NEOadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The NEO Trial

    Complexity Level: 2

    Eligibility: - Histologically confirmed invasive well-moderately differentiated rectal adenocarcinoma diagnosed within 90 days prior to enrollment. - Tumour stage cT1-T3abN0 based on pelvic MRI - cN0 stage based on pelvic MRI - No contraindications to protocol chemotherapy - M0 stage based on no evidence of metastatic disease by CT imaging - Mid to low-lying tumor eligible for local tumor excision in the opinion of the treating surgeon - Medically fit to undergo radical surgery as per treating surgeon's discretion - Patient does not have pathologic high risk factors on either/ or the initial biopsy specimen report or follow up biopsy (if done): high histologic grade, mucinous histology, lymphatic or vascular invasion

    Objectives: Protocol specified organ preservation rate

    NCT Registration ID (from clinicaltrials.gov): NCT03259035
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: August 22, 2017



    Open to Accrual
    GA3 (AGITG-AG0315OG)A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)
    This study will evaluate the effect of a drug called regorafenib for treatment of advanced gastro-oesophageal cancer. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) gastro-oesophageal cancer which has not responded to treatment. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take regorafenib (Group 1) or a placebo (inactive substance) (Group 2) tablet once per day on days 1-21 of each 28 day cycle. Treatment will continue until disease progression or prohibitive adverse events. Participants will not know whether they are taking regorafenib or the placebo until after the trial is completed. Participants will be followed up every 2-4 weeks in order to evaluate how they are responding to treatment.
    A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

    Complexity Level: 2

    Eligibility: Adults with histologically or cytologically confirmed advanced gastro-oesophageal Cancer (AGOC), with measurable metastatic or locally advanced disease, who have failed or were intolerant of 2 lines of prior anti-cancer therapy which have included a platinum & fluoropyrimidine analogue.

    Objectives: Primary Objective: OS in overall study population and in the Asian sub-population Secondary Objectives: PFS, Objective tumour response rate (PR or CR); Quality of life (QoL); Safety (rates of adverse events)

    NCT Registration ID (from clinicaltrials.gov): NCT02773524
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: January 09, 2017



    Open to Accrual
    HE1Phase III Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases
    Primary liver cancer (i.e. hepatocellular carcinoma) and secondary liver cancer (i.e. metastases that have spread to the liver from another primary cancer site such as colon cancer or breast cancer) are most often not treatable with surgery or other local therapies. When the cancer grows to involve most of the liver, it can cause pain that can be difficult to control and may reduce a patient's quality of life. This clinical trial aims to test whether low dose radiation therapy improves pain in patients with liver cancer who are not candidates for standard cancer therapies.
    Phase III Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases

    Complexity Level: 2

    Eligibility: Key eligibility criteria include diffuse, multifocal or locally advanced cancer involving the liver. Patients must be unsuitable for standard local, regional or systemic therapy, ECOG PS 0-3, Child Pugh not greater than C10, liver enzymes <10X ULN, and expected survival >3 months. In the 7 days prior to randomization, patients must have no significant change (range of 3 points is allowable) in pain score as measured over 2 days. All patients will receive best supportive care, and it is recommended that this include a palliative care or pain specialist assessment prior to randomization, when available.

    Objectives: The primary objective is to determine if patients with symptomatic liver tumours (either HCC or liver metastases) who undergo BSC plus a single 8 Gy fraction of radiation therapy to the liver experience a significant improvement in symptoms (defined as a >\= 2 point decrease in their pain "intensity at worst" score on the BPI) from baseline to 30 days as compared to patients receiving BSC alone. The secondary objectives are to compare the two treatment arms with respect to (1) proportion of patients experiencing grade >/= 2 adverse events at 30 days and 90 days, (2) proportion of patients alive at 90 days, (3) proportion of patients achieving improvement of liver cancer pain/discomfort by >\= 2 points from baseline to day 30 and day 90 in all BPI pain scores, (4) Proportion of patients reporting clinically significant improvement in QoL from bassline to day 30 and day 90, and (5) Proportion of patients achieving a 25% reduction in opioid use at 30 days.

    NCT Registration ID (from clinicaltrials.gov): NCT02511522
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: July 23, 2015



    Open to Accrual
    GA1 (TROG 0808)A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)
    This study will see if the addition of pre-operative chemoradiotherapy prior to surgery to the standard pre-operative chemotherapy, surgery and post-operative chemotherapy improves response rates and overall survival. You may be eligible for this trial if you aged >=18 years and have been diagnosed with esophago-gastric cancer which, in the opinion of your doctor, can be completely removed by surgery. Participants in this trial will be randomly (by chance) allocated to one of two groups. Patients randomised to Group 1 will receive 3 cycles of ECF, ECX, or EOX at 3-weekly intervals or 4 cycles of FLOT at 2-weekly intervals pre-op. Patients randomised to Group 2 will receive 2 cycles of ECF, ECX, or EOX or 3 cycles of FLOT pre-op, then 2-4 week break before chemoradiotherapy. Surgery for both groups should be performed within 6 weeks of the end of the last pre-op cycle. Post-op chemo should be started within 4-10 weeks after surgery: 3 cycles of ECF, ECX, or EOX or 4 cycles of FLOT.
    A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)

    Complexity Level: 2

    Eligibility: Patients with resectable adenocarcinoma of stomach or gastroesophageal junction, Stage IB (T1N1) - IIIC (T3,4 and/or N+ve).

    Objectives: Primary: Overall Survival Secondary: DSF, toxicity, pCR rate, Surgical R0 Resection rate, , QoL; Economics; A biologic correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01924819
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: July 31, 2013



    Open to Accrual
    CRC8 (ECOG-ACRIN EA2165)A Randomized Phase II Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer
    The purpose of this study is to find if adding the study drug, nivolumab, after standard chemotherapy and radiation will prevent the anal cancer from returning. Nivolumab is a drug that may turn on the body's immune system to attach any cancer cells that may remain after chemotherapy and radiation. The addition of nivolumab may help prevent your cancer from returning, but it could also cause side effects. This research study will allow researchers to find out whether this different treatment is better, the same, or worse than the usual treatment for anal cancer. To do this, half the patients in this study will get nivolumab and the other half will be monitored with standard follow-up treatment. You will know what treatment you will get. If you are randomized to receive nivolumab, your treatment will last approximately 6 months.
    A Randomized Phase II Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer

    Complexity Level: 2

    Eligibility: Registration step 1: Patients with histologicallyproven stage II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma. For patients registering to Arm T, they must not have recieved prior chemoradiotherapy for anal cancer. Registration to step 2: Patients will be registered no sooner than 4 weeks following completion of standard chemoradiation for anal cancer (no less than 54 Gy). Patients must have histologically proven state II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma.

    Objectives: Primary objective: To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves Disease-Free Survival (DFS) compared with observation in patients with high risk anal carcinoma. Secondary objectives: To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with ragard to objective response rate (complete CR and partial PR), stable disease and progression; severe toxicity interval; colostomy-free survival; overall survival; toxicity.

    NCT Registration ID (from clinicaltrials.gov): NCT03233711
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: August 16, 2018



    Open to Accrual
    CO26A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients with Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies
    The purpose of the study is to compare the effects on colon or rectal cancer of 2 new drugs, durvalumab and tremelimumab, and best supportive care (BSC) compared to BSC alone.
    A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients with Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies

    Complexity Level: 2

    Eligibility: MAIN INCLUSION CRITERIA: Metastatic pre-treated colorectal cancer; Archival tissue available for correlative analysis; ECOG PS 0,1; Sufficient prior treatment with standard chemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin; Measurable or evaluable disease as per RECIST 1.1; MAIN EXCLUSION CRITERIA: Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab; Medical contraindications to durvalumab (e.g. autoimmune disease); Prior immunotherapy or vaccines; Prior history of immunodeficiency; Prior use of immunosuppressive agents within 28 days, with the exception of corticosteroids (intranasal and inhaled) or systemic corticosteriods at physiological doses.

    Objectives: PRIMARY: Overall Survival SECONDARY: Progression Free Survival; assess toxicity and safety; Objective Response Rate TERTIARY: QoL; effect of tumour PD-L1 expression on efficacy; explore association between putative biomarkers (in archival tumour, blood, serum and plasma) and potential for clinical benefit

    NCT Registration ID (from clinicaltrials.gov): NCT02870920
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: August 10, 2016 Closing Date: June 29, 2017



    Closed to Accrual
    CRC3 (ECOG E5202)A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers
    The purpose of this study is to compare the effects of providing further treatment to patietns with colon cancer after surgery, if they are at high risk for recurrence. This research is being done: -To determine whether specific tests done on a tumour (found in the colon) can be used to predict recurrence of tumours in patients with stage II colon cancer. -To compare the effects (good and bad) of a combination of chemotherapy drugs, when given with and without a new drug, bevacizumab, on patients with stage II colon cancer at high-risk for recurrence.
    A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

    Complexity Level: 2

    Eligibility: Patients must have histologically confirmed adenocarcinoma of the colon that meets the criteria below: Stage II carcinoma (T3,4 N0 M0): The tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3) or directly invades other organs or structures and/or perforates visceral peritoneum (T4). The distal extent of the tumor must be > 12 cm from the anal verge on endoscopy. If the patient is not a candidate for endoscopy, then the distal extent of the tumor must be > 12 cm from the anal verge as determined by surgical examination. Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk. Tumor samples and normal mucosa will be shipped as specified in Section 10.2. High-risk patients will be randomized to treatment Arms A or B. Low-risk patients will be registered to Arm C for observation.

    Objectives: Primary: To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU, leucovorin, oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab. Secondary: To compare overall survival between the regimens.To further define the toxicity profiles of the regimens. To prospectively determine the impact of tumor biological characteristics on survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00217737
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 27, 2006 Closing Date: February 11, 2011



    Closed to Accrual
    PA7 (PA7)A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
    The purpose of the study is to compare the effects on pancreatic cancer by adding 2 new drugs, durvalumab and tremelimumab, to the standard chemotherapy of Gemcitabine and nab-paclitaxel.
    A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma

    Complexity Level: 2

    Eligibility: Inclusion Criteria: Metastatic pancreatic ductal adenocarcinoma No prior treatment for metastatic disease May have received prior adjuvant Gemcitabine if longer then 6 months before recurrence Archival tissue available for correlative analysis ECOG PS 0,1 Exclusion Criteria: Medical contraindications to Gemcitabine or Nab-Paclitaxel Medical contraindications to MEDI 4736 (e.g. autoimmune disease)

    Objectives: Primary: - overall survival (OS) Secondary: -Progression Free Survival (PFS) - Toxicity and Safety - Objective Response Rate (ORR) Tertiary Endpoints: - Quality of Life (QoL) - Correlative Studies (PD-L1, hENT/SPARC,gene expression, ciruclating tumour DNA)

    NCT Registration ID (from clinicaltrials.gov): NCT02879318
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: August 22, 2016 Closing Date: July 26, 2018



    Closed to Accrual
    PA6 (UNICANCER ACCORD24)Multicentre Randomized Phase III Trial Comparing 6-Month Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) In Patients With Resected Pancreatic Adenocarcinoma
    The purpose of this study is to find out whether standard treatment with gemcitabine or combination treatment with 5-fluorouricil, leucovorin, irinotecan and oxaliplatin (mFOLFIRINOX) is better at preventing pancreatic cancer that has been sugically removed from coming back.To do this, half of the patients in this study will get gemcitabine and the other half will receive combination chemotherapy (mFOLFIRINOX). You will know what treatment you will get and both treatments last approximately 6 months.
    Multicentre Randomized Phase III Trial Comparing 6-Month Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) In Patients With Resected Pancreatic Adenocarcinoma

    Complexity Level: 2

    Eligibility: Inclusion Criteria:- Histologically proven pancreatic ductal adenocarcinoma, Macroscopically complete resection (R0 or R1 resection), Patients aged from 18 to 79 years, Performance status 0-1, - No prior radiotherapy and no previous chemotherapy, No heart failure or coronary heart disease symptoms,Satisfactory postoperative recovery and patient able to receive chemotherapy,adequate oral nutrition of at least 1500 calories per day, free of significant nausea and vomiting,adequate hematologic function, Adequate liver function (bilirubin . 1.5 xUNL), Creatinine clearance > 50 mL/min, interval since the surgery between 21 and 84 days, patient information and signed informed consent. Exclusions: Non ductal adenocarcinoma of the pancreas (eg endocrine, acinar cell, cystadenocarcinoma and ampulloma), Metastases (including ascites or pleural malignant effusion), macroscopic incomplete tumour resection (R2), CA 19-9> 180u/ML within 21 day prior to randomization, concurrent/prior other cancer.

    Objectives: Primary: Disease-Free Survival Secondary: Overall Survival

    NCT Registration ID (from clinicaltrials.gov): NCT01526135
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 17, 2012 Closing Date: September 07, 2016



    Closed to Accrual
    NEC3 (ALLIANCE A021202)Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors
    This study will evaluate the effect of a drug called pazopannib for treatment of worsening carcinoid tumours. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with (metastatic or locally recurrent) neuroendocrine cancer which cannot be removed by surgery or has spread. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take pazopanib (Group 1) or a placebo (inactive substance) (Group 2) tablets once per day. Treatment will continue until disease progression or prohibitive adverse events. Participants will not know whether they are taking regorafenib or the placebo. Participants will be followed up every 2-4 weeks in order to evaluate how they are responding to treatment.
    Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors

    Complexity Level: 2

    Eligibility: Patients with low or intermediate grade neuroendocrine carcinoma arising from the foregut, midgut, hindgut or other non-pancreatic site which is locally unresectable or metastatic. Must have measurable disease with radiological evidence of PD (may be either measure or non-measure PD). No prior treatment with an inhibitor of VEGF or VEGFR.

    Objectives: Primary Objectives: PFS Secondary Objectives: Objective tumour response rate (PR or CR); Overall survival (OS); Duration of Response (DR); Time to treatment failure (TTF) and Time to second progression for patients who crossover from placebo to active therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT01841736
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 28, 2014 Closing Date: October 07, 2016



    Closed to Accrual
    ES2 (TROG 03.01)A Randomized Phase III Study in Advanced Oesophageal Cancer To Compare Quality of Life and Palliation of Dysphagia In Patients Treated With Radiotherapy Versus Chemo-Radiotherapy.
    The purpose of this study is to compare the effects on the patient and their esophageal cancer of radiation therapy alone to radiation therapy with chemotherapy (drug therapy) to treat this disease. This research is being done because we do not know which of these two treatments is better
    A Randomized Phase III Study in Advanced Oesophageal Cancer To Compare Quality of Life and Palliation of Dysphagia In Patients Treated With Radiotherapy Versus Chemo-Radiotherapy.

    Complexity Level: 2

    Eligibility: Patients with squamous cell or adenocarcinoma of the oesophagus who are deemed not suitable for definitive radical treatment due to the advanced nature of disease, presence of metastases or intercurrent illness, who have symptomatic dysphagia requiring loco-regional palliation.

    Objectives: To compare strategies to improve dysphagia in a simple fashion with minimal toxicity. To compare the toxicity of treatment with radiotherapy alone (RT) versus the same dose RT with added chemotherapy. To gain experience in the assessment of quality of life and improvement of dysphagia between the two regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00193882
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 27, 2003 Closing Date: March 21, 2012



    Closed to Accrual
    CRC6 (CALGB C80702)A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo For Patients With Resected Stage III Colon Cancer
    The common combination of chemotherapy drugs used to treat adenocarcinoma of the colon in the adjuvant setting is: 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, (also called "FOLFOX") for 12 cycles of treatment and is considered the standard of care for most patients. Celecoxib is a non-steroidal anti-inflammatory drug (NSAID), which inhibits the COX-2 enzyme. Previous studies have shown that COX-2 inhibitors improve the outcome in early-stage colon cancer. The purpose of this study is 2-fold: to determine whether 12 treatments or 6 treatments of the chemotherapy is better at preventing the return of the cancer. Also whether the addition of celecoxib to the chemotherapy, aids in the prevention of the return of the cancer.
    A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo For Patients With Resected Stage III Colon Cancer

    Complexity Level: 2

    Eligibility: Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must be at least 12 centimeters from the anal verge (i.e., patients with rectal cancer are not eligible).

    Objectives: To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.

    NCT Registration ID (from clinicaltrials.gov): NCT01150045
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 28, 2011 Closing Date: November 20, 2015



    Closed to Accrual
    CRC7 (ALLIANCE N1048)A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)
    The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemothearpy and radiation to chemotherapy using a combination regigmen known a FOLFOX and selective use os the stardard treatment depending on the response to the FOLFOX prior to surgery.
    A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)

    Complexity Level: 2

    Eligibility: Histologically confirmed clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB) adenocarcinoma of the rectum where standard treatment recommendation would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection

    Objectives: Primary Outcomes: Pelvic R0 resection rate (phase II) DFS (Phase III) Time to local recurrence (TLR)

    NCT Registration ID (from clinicaltrials.gov): NCT01515787
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 17, 2012 Closing Date: December 28, 2018



    Closed to Accrual
    BI1Phase III Trial of Combined Gemcitabine Plus Capecitabine Chemotherapy Versus Gemcitabine Alone in Advanced Biliary Cancer.
    The purpose of this study is to find out whether it is better to receive a capecitabine in combination with gemcitabine, or better to receive only gemictabine for biliary cancer.
    Phase III Trial of Combined Gemcitabine Plus Capecitabine Chemotherapy Versus Gemcitabine Alone in Advanced Biliary Cancer.

    Eligibility: Patients with histologically/cytologically proven adenocarcinoma of the biliary tree (intra and extra-hepatic biliary ducts or gallbladder) that is either unresectable or metastatic. Patient must have evidence of disease but measurable disease is not required. They may not ahve received previous chemotherapy for advance or metastatic disease unless used as a radiosensitizer. Must have life expecency > or = 12 weeks.

    Objectives: Primary: Overall survival. Secondary: Progression-free survival, response rates (CR and PR), rate of stable disease (SD), rate of disease control (CR, PR and SD), response duration, quality of life, toxicity

    NCT Registration ID (from clinicaltrials.gov): NCT00658593
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 19, 2008 Closing Date: July 14, 2009



    Permanently Closed
    CO10A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer

    A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00002570
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 15, 1994 Closing Date: March 31, 1999



    Permanently Closed
    CO11 (9304)A Postoperative Evaluation of 5FU by Bolus Injection versus 5FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion + Pelvic XRT versus Bolus 5FU + Leucovorin + Levamisole Prior to and Following Combined Pelvic XRT + Bolus 5FU + Leucovorin in Patients With Rectal Cancer

    A Postoperative Evaluation of 5FU by Bolus Injection versus 5FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion + Pelvic XRT versus Bolus 5FU + Leucovorin + Levamisole Prior to and Following Combined Pelvic XRT + Bolus 5FU + Leucovorin in Patients With Rectal Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00002551
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 12, 1995 Closing Date: August 01, 2000



    Permanently Closed
    CO12 (93-46-53)A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Colectomy Versus Open Colectomy for Colon Cancer

    A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Colectomy Versus Open Colectomy for Colon Cancer

    Eligibility: Patients must have the clinical diagnosis of adenocarcinoma involving a single colon segment of the right, left or sigmoid colon. Patient must not have prohibitive scars/ adhesions from previous abdominal surgery.

    Objectives: To test the hypothesis that disease-free survival and overall survival are equivalent, regardless of whether patients receive laparoscopic assisted colectomy or open colectomy. To determine the safety of laporoscopic assisted colectomy compared to open colectomy with respect to early and late morbidities and 30 day mortality.

    NCT Registration ID (from clinicaltrials.gov): NCT00002575
    Participation: Limited to pre-approved, designated surgeons at centres with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 27, 1996 Closing Date: August 31, 2001



    Permanently Closed
    CO6 (9081)Intergroup Rectal Adjuvant Protocol: A Phase III Study

    Intergroup Rectal Adjuvant Protocol: A Phase III Study

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 04, 1991 Closing Date: November 22, 1992



    Permanently Closed
    GA2 (AGITG AG0212OG)INTEGRATE-A Randomized Phase II Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Esophago-Gastric Cancer (AEGC)
    This study will evaluate the effect of a drug called regorafenib for treatment of advanced esophago-gastric cancer. You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) esophago-gastric cancer which has not responded to treatment. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take regorafenib (Group 1) or a placebo (inactive substance) (Group 2) tablet oncer per day on days 1-21 of each 28 day cycle. Treatment will continue until disease progression or prohibitive adverse events. Participants will not know whether they are taking regorafenib or the placebo until after the trial is completed. Participants will be followed up every 2-4 weeks in order to evaluate how they are responding to treatment.
    INTEGRATE-A Randomized Phase II Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Esophago-Gastric Cancer (AEGC)

    Complexity Level: 2

    Eligibility: Adults with histologically or cytologically confirmed Esophago-gastric Cancer (EGC), with measurable metastatic or locally advanced disease, that is refractory to first or second line chemotherapy, or for whom second line chemotherapy is not appropriate.

    Objectives: Primary Objective: PFS Secondary Objectives: Objective tumour response rate (PR or CR); Clinical benefit at 2 months (CR or PR or SD); Overall survival (OS); PFS by Vascular Endothelial Growth Factor-A (VEGF-A) circulating levels (PD or Death by plasma VGEF: high vs low subgroups): Safety (rates of adverse events); Quality of life (QoL); all by arm to obtain reference values applicable to the control arm and design of a possible subsequent phase III trial. inform the design (e.g. sample size calculations) of any future phase III trial

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 2012 Closing Date: March 13, 2014



    Permanently Closed
    CO4Clinical Trial of Adjuvant 5FU/Folinic Acid in Rectal Cancer

    Clinical Trial of Adjuvant 5FU/Folinic Acid in Rectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 16, 1989 Closing Date: May 11, 1990



    Permanently Closed
    CO3Clinical Trial of Adjuvant Therapy With 5-Fluorouracil and Folinic Acid in Patients With Resectable Adenocarcinoma of the Colon

    Clinical Trial of Adjuvant Therapy With 5-Fluorouracil and Folinic Acid in Patients With Resectable Adenocarcinoma of the Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 20, 1987 Closing Date: January 03, 1992



    Permanently Closed
    PA1A Phase III Study of Bay 12-9566 Versus Gemcitabine in Patients with Advanced or Metastatic Adenocarcinoma of the Pancreas

    A Phase III Study of Bay 12-9566 Versus Gemcitabine in Patients with Advanced or Metastatic Adenocarcinoma of the Pancreas

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 15, 1997 Closing Date: July 06, 1999



    Permanently Closed
    CRC1 (E3200)A Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin versus Oxaliplatin, Fluorouracil and Leucovorin versus Bevacizumab Alone in Previously Treated Patients with Advanced Colorectal Cancer

    A Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin versus Oxaliplatin, Fluorouracil and Leucovorin versus Bevacizumab Alone in Previously Treated Patients with Advanced Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00025337
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2003 Closing Date: April 28, 2003



    Permanently Closed
    NEC2 (CALGB C80701)Randomized Phase II Study of Everolimus Alone versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours
    The purpose of this study is to test what effects, good and/or bad, three new drugs or drug combinations have on patients with advanced pancreatic neuroendocrine cancer. The three regimens are: ? bevacizumab ? bevacizumab and everolimus ? bevacimab and temozolomide Bevacizumab has been approved by the FDA for the treatment of some types of cancer but not for your type of cancer and should be considered experimental. Temozolomide and everolimus are also considered experimental for the treatment of pancreatic neuroendocrine tumors.
    Randomized Phase II Study of Everolimus Alone versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours

    Complexity Level: 2

    Eligibility: Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours.

    Objectives: Primary: To assess the progression-free survival rate of patients with locally advanced or metastastic pancreatic neuroendocrine tumors treated with one of three novel regimens: bevacizumab alone, bevacizumab plus everolimus, or bevacizumab plus temozolomide. Secondary: Overall tumor response rate; overall biochemical response; toxicity; overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT01229943
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 30, 2011 Closing Date: October 01, 2012



    Permanently Closed
    PAC2 (E4201)A Randomized Phase III Study of Gemcitabine in Combination With Radiation Therapy Versus Gemcitabine Alone in Patients With Localized, Unresectable Pancreatic Cancer.

    A Randomized Phase III Study of Gemcitabine in Combination With Radiation Therapy Versus Gemcitabine Alone in Patients With Localized, Unresectable Pancreatic Cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00057876
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 31, 2001 Closing Date: December 15, 2005



    Permanently Closed
    PAC1 (S0205)A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-225) Versus Gemcitabine as First Line Therapy of Patients with Advanced Pancreas Cancer
    The purpose of this study is to compare the effects on the patient and their pancreas cancer of a new drug cetuximab given to the patient in combination with gemcitabine compared with treatment of gemcitabine alone. This research is being done because currently there is no effective treatment for this type of cancer. Better ways are needed to treat patients like you. Gemcitabine is the standard and FDA approved therapy for advanced pancreas cancer. This study will compare the effects (good and bad) of giving gemcitabine with the experimental drug cetuximab to gemcitabine alone
    A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-225) Versus Gemcitabine as First Line Therapy of Patients with Advanced Pancreas Cancer

    Eligibility: Patients with advanced pancreatic cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00075686
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 23, 2004 Closing Date: April 01, 2006



    Permanently Closed
    HEC1 (CALGB 80802)Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)
    The purpose of this study is to compare the effects (good and bad) of the drug sorafenib with the combination of sorafenib plus doxorubicin on the patient and their advanced primary liver cancer to find out which is better. In this study, the patient will get either the combination of sorafenib plus doxorubicin or they will receive sorafenib alone.
    Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)

    Complexity Level: 2

    Eligibility: Pathological or cytologically proven hepatocellular carcinoma. Locally advanced or metastatic disease. Patients must have measurable disease. No prior adjuvant therapy with sorafenib or other Raf/VEGFR inhibitors. No prior systemic tx for metastatic disease; Antiviral tx is allowed, but interferon therapy must be stopped >4 weeks prior to registration. Allografts are not allowed, including but not limited to liver and bone marrow transplants. No known CNS tumors including brain metastases. No significant GI bleeding events requiring intervention, transfusion, or admission to hospital within 30 days prior to study entry. > 4 weeks since major surgery. No rifampin or St. John's Wort; Hypertension must be well controlled. No known history of congestive heart failure > NYHA II or cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin. ECOG status 0-1

    Objectives: Primary: Compare overall survival (OS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib. Secondary: Compare time to progression (TTP); Progression-free survival (PFS); Tumor response using RECIST.

    NCT Registration ID (from clinicaltrials.gov): NCT01015833
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 03, 2011 Closing Date: May 21, 2015



    Permanently Closed
    CO1Protocol for a Clinical Trial of Carcinoma of the Colon and Rectum Utilizing Immunotherapy With and Without Chemotherapy as an Adjuvant to Surgery

    Protocol for a Clinical Trial of Carcinoma of the Colon and Rectum Utilizing Immunotherapy With and Without Chemotherapy as an Adjuvant to Surgery

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 01, 1978 Closing Date: September 01, 1981



    Permanently Closed
    CO14 (9581)Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon
    The purpose of this study is to compare the effects (good and bad) of an experimental drug called Monoclonal Antibody 17-1A (or MoAb17-1A) to standard care (which is no treatment and careful observation) to see which is better. MoAb17-1A is unlike chemotherapy drugs commonly used to treat cancer because MoAb17-1A can attack cancer or tumor cells in a way different than these chemotherapy drugs.
    Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon

    Eligibility: Pathologically documented Stage II pT3N0 or pT4bN0 (Modified Astler-Coller B2) colon adenocarcinoma. Complete, en bloc resection of all of the primary tumour, performed as an open procedure and not laparoscopically or laparoscopically assisted. No evidence of perforation or clinical obstruction of the bowel. The gross distal margin of the primary tumour must lie above the peritoneal reflection (i.e. it must be a colon, not a rectal cancer). No previous radiation or chemotherapy for this malignancy. Age > 18 years. CALGB performance status 0 - 1. No current corticosteroid therapy for any reason. No prior exposure to murine antibodies. No uncontrolled or severe cardiovascular disease. No history of pancreatitis. Non-pregnant and non-lactating. No previous or concurrent malignancy.

    Objectives: To determine whether adjuvant treatment with MoAb 17-A will improve the probability of overall and disease-free survival, and increase disease-free intervals in patients who have undergone resection of a stage II (pT3N0 or pT4bN0) colon cancer. To evaluate a panel of prognostic markers, in order to correlate these measures with survival and recurrence after adjuvant therapy in patients who have undergone resection of a Stage II (pT3N0 or pT4bN0) colon cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00002968
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 12, 1999 Closing Date: May 31, 2002



    Permanently Closed
    PA2 (ESPAC-3(V2))Phase III Adjuvant Trial In Pancreatic Cancer Comparing (1) 5FU And D-L Folinic Acid Vs (2) Gemcitabine Vs (3) No Adjuvant Treatment
    The purpose of this study is to find out whether extra treatment with chemotherapy is better than surgery alone for people with the same type of cancer and if there is any difference between different types of treatment. This study will also compare the effects of the different types of treatment (5-FU and folinic acid vs. gemcitabine).
    Phase III Adjuvant Trial In Pancreatic Cancer Comparing (1) 5FU And D-L Folinic Acid Vs (2) Gemcitabine Vs (3) No Adjuvant Treatment

    Complexity Level: 2

    Eligibility: Eligible patients have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection). Patients may also be included who have had complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection) and (R0 or R1 resection)for(i) unusual malignancies of the pancreas such as ascinar cell carcinoma, cystadenocarcinoma, etc.; (ii) cancers of the periampullary region; (iii) cancers of the intra-pancreatic part of the bile duct; (iv) periampullary cancers of uncertain origin.

    Objectives: This adjuvant study will test two hypotheses in a three arm study. A) Does either adjuvant gemcitabine or 5FU + folinic acid improve survival compared to no additional treatment following resection of pancreatic cancer. B) Is there any difference between gemcitabine and 5FU + folinic acid in terms of survival when used as adjuvant therapy following resection of pancreatic cancer. The primary endpoint is 2-year survival. Secondary endpoints will be toxicity, quality of life, and 5-year survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00058201
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 31, 2001 Closing Date: May 06, 2008



    Permanently Closed
    PA3A Randomized Placebo Controlled Study of OSI-774 Plus Gemcitabine in Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

    A Randomized Placebo Controlled Study of OSI-774 Plus Gemcitabine in Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

    Eligibility: Patients with locally advanced, unresectable or metastatic adenocarcinoma of the pancreas who have received no prior chemotherapy other than 5FU (plus/ minus folinic acid) or gemcitabine given concurrently with radiation treatment as a radiosensitiser. Patients must have evidence of disease, but measureable disease is not mandatory.

    Objectives: The primary objective of the study is to compare the survival of patients in the two treatment groups, gemcitabine plus OSI-774 and gemcitabine plus placebo. Secondary objectives include comparison between the two groups of progression-free survival; quality of life; response rate; response duration; and toxicities. Further secondary objectives are to correlate the expression of tissue EGFR levels (at diagnosis) with outcomes and response to treatment, and to measure trough levels of OSI-774 to define population pharmacokinetics.

    NCT Registration ID (from clinicaltrials.gov): NCT00026338
    Participation: Initially limited to Canadian centres with IND Program experience; opened world-wide Mar 30, 2002.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 29, 2001 Closing Date: January 31, 2003



    Permanently Closed
    CO2Systemic Infusion versus Bolus Chemotherapy With 5-Fluorouracil in Measurable Metastatic Colorectal Cancer

    Systemic Infusion versus Bolus Chemotherapy With 5-Fluorouracil in Measurable Metastatic Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 31, 1986 Closing Date: January 31, 1989



    Permanently Closed
    CRC5 (CALGB C80405)A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
    The common combinations of chemotherapy drugs used to treat metastatic adenocarcinoma of the colon or rectum are: 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called "FOLFOX;"the other combination uses 5-FU, leucovorin, and irinotecan, this combination is also called "FOLFIRI" in combination with a drug called bevacizumab (or Avastin) is considered the standard of care for most patients. Cetuximab (or Erbitux) is an antibody that targets and blocks a specific part of the cancer tumor that is felt to encourage tumor growth. The purpose of this study is to determine whether one of the following two combinations: cetuximab plus chemotherapy, or cetuximab plus bevacizumab plus chemotherapy, is better than the combination of bevacizumab with chemotherapy.
    A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

    Complexity Level: 2

    Eligibility: Histologically confirmed locally advanced or metastatic and untreated adenocarcinoma of the colon or rectum.

    Objectives: To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy with and without bevacizumab prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced ormetastatic colorectal cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00265850
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 03, 2008 Closing Date: March 01, 2012



    Permanently Closed
    CO9QLComparison of Quality of Life (QOL) in Patients Receiving High and Standard Dose Levamisole Plus 5-Fluorouracil and Leucovorin as Adjuvant Therapy for High-Risk Colon Cancer. A companion protocol to CO.9

    Comparison of Quality of Life (QOL) in Patients Receiving High and Standard Dose Levamisole Plus 5-Fluorouracil and Leucovorin as Adjuvant Therapy for High-Risk Colon Cancer. A companion protocol to CO.9

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 18, 1996 Closing Date: January 27, 1998



    Permanently Closed
    GAC1 (CALGB C80101)Phase III Randomized Study of Adjuvant Chemoradiation After Resection in Patients with Gastric or Gastroesophageal Adenocarcinoma
    This is a multi-centre cooperative group randomized Phase III trial targeting patients who have had surgical resection of gastric or gastroesophageal adenocarcinoma. Study treatment is not blinded. The total duration of the study will be approximately 7.5 years.
    Phase III Randomized Study of Adjuvant Chemoradiation After Resection in Patients with Gastric or Gastroesophageal Adenocarcinoma

    Complexity Level: 2

    Eligibility: Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinoma of the esophagus that are not involving the gastroesophageal junction are not eligible.

    Objectives: To determine whether overall survival is prolonged in patients with resected gastric adenocarcinoma who receive epirubicin, cisplatin and infusional 5-FU (ECF) before and after infusional 5-FU plus radiotherapy (RT) when compared to those treated with bolus 5-FU and leucovorin before and after infusional 5-FU plus RT.

    NCT Registration ID (from clinicaltrials.gov): NCT00052910
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 29, 2004 Closing Date: May 29, 2009



    Permanently Closed
    CRC4 (ECOG E5204)Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation
    This study will compare the overall survival in patients with clinical stage II and stage III rectal cancer who received preoperative chemoradiation and surgery and will compare the investigational treatment combination of oxaliplatin, fluorouracil and leucovorin with or without bevacizumab.
    Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation

    Complexity Level: 2

    Eligibility: Patients must have histologically-proven adenocarcinoma of the rectum with no distant metastases. Clinical (before neoadjuvant therapy) and pathologic staging are required. Patients with clinical stage T3N0M0, T4N0M0, TanyN1-2M0 are eligible. Patients must have received a minimum radiation dose of 40 Gy and not more than 55.8 Gy. Patients must have a completely resected tumor with no evidence of metastatic disease on the surgical/intra-operative examination and be between 28-56 days from the date of surgery

    Objectives: To compare the overall survival of patients with clinical Stage II and III rectal cancer who received preoperative chemoradiation and were treated with oxaliplatin leucovorin, 5-FU with or without bevacizumab postoperatively.

    NCT Registration ID (from clinicaltrials.gov): NCT00303628
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 12, 2006 Closing Date: April 29, 2009



    Permanently Closed
    CRC2 (NCCTG N0147)A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer
    This study is being done in patients who have had surgery for colon cancer. This research is being done because there have been no trials so far to determine if C225 helps prevent cancer from coming back. Cetuximab (C225) has been used to treat people whose cancer continues to grow after they receive the chemotherapy drug irinotecan (CPT-11). C225 is being used in this study to see if it helps prevent cancer from coming back when added to chemotherapy.
    A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

    Complexity Level: 2

    Eligibility: Histologically confirmed adenocarcinoma of the colon, Stage III disease. The gross inferior (caudad) margin of the primary tumor must be greater than or equal to 12 cm from the anal verge by rigid proctoscopy. Tumor must have been completely resected within past 56 days. At least one pathologically confirmed positive lymph node. No evidence of residual involved lymph node disease. No distant metastatic disease.

    Objectives: To compare disease-free survival of patients with curatively resected stage III colon cancer treated with adjuvant irinotecan vs oxaliplatin and fluorouracil and leucovorin calcium vs both regimens given consecutively (all irinotecan-containing treatment arms are closed to accrual as of 6/1/2005). To compare the disease-free survival of patients treated with these regimens with vs without cetuximab.

    NCT Registration ID (from clinicaltrials.gov): NCT00079274
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 22, 2004 Closing Date: November 25, 2009



    Permanently Closed
    CO9SN (93-46-51)Evaluation of Serum Neopterin in Patients Receiving High-Dose Levamisole or Standard-Dose Levamisole in Combination with 5-FU (Fluorouracil) and Leucovorin as Surgical Adjuvant Therapy for High-Risk Colon Cancer. An NCCTG companion protocol to CO.9

    Evaluation of Serum Neopterin in Patients Receiving High-Dose Levamisole or Standard-Dose Levamisole in Combination with 5-FU (Fluorouracil) and Leucovorin as Surgical Adjuvant Therapy for High-Risk Colon Cancer. An NCCTG companion protocol to CO.9

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1994 Closing Date: October 25, 1996



    Permanently Closed
    CO9PA (98-46-54)The Clinical and Pathologic Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

    The Clinical and Pathologic Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 28, 2000 Closing Date: March 31, 2001



    Permanently Closed
    CO9 (914653)A Phase III Evaluation of High-Dose Levamisole Plus 5FU and Leucovorin as Surgical Adjuvant Therapy for High Risk Colon Cancer

    A Phase III Evaluation of High-Dose Levamisole Plus 5FU and Leucovorin as Surgical Adjuvant Therapy for High Risk Colon Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003833
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 12, 1993 Closing Date: January 27, 1998



    Permanently Closed
    CO8 (91-46-52)Phase III Study of Radiation Therapy, Levamisole and 5-Fluorouracil vs 5-Fluorouracil and Levamisole in Selected Patients With Completely Resected Colon Cancer.

    Phase III Study of Radiation Therapy, Levamisole and 5-Fluorouracil vs 5-Fluorouracil and Levamisole in Selected Patients With Completely Resected Colon Cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 03, 1993 Closing Date: December 17, 1996



    Permanently Closed
    CO7Phase III Clinical Trial of Chemotherapy with 5-Fluorouracil and L-leucovorin Following Potentially Curative Resection of Liver or Lung Metastases from Colorectal Cancer

    Phase III Clinical Trial of Chemotherapy with 5-Fluorouracil and L-leucovorin Following Potentially Curative Resection of Liver or Lung Metastases from Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 1994 Closing Date: January 23, 1998



    Permanently Closed
    CO5 (89-46-51)A Controlled Phase III Evaluation of 5fu Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer

    A Controlled Phase III Evaluation of 5fu Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 16, 1990 Closing Date: October 11, 1991



    Permanently Closed
    CO13 (N9741)A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-fluorouracil (5-FU), and Irinotecan (CPT-11) as Initial Treatment of Patients with Advanced Adenocarcinoma of the Colon and Rectum
    The purpose of this study is to determine how effective the drugs irinotecan hydrochloride (CPT-11), and oxaliplatin (OXAL), and 5-Fluorouracil (5-FU), and folinic acid (CF) are when given in one of three different combinations to patients who have locally advanced or metastatic colorectal cancer, evaluate side effects and survival experienced by patients receiving these drugs, and to study the effects of treatment on the participant?s quality of life (changes to daily routines and feelings of overall health).
    A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-fluorouracil (5-FU), and Irinotecan (CPT-11) as Initial Treatment of Patients with Advanced Adenocarcinoma of the Colon and Rectum

    Eligibility: Known locally advanced, locally recurrent or metastatic colorectal adenocarcinoma not curable by surgery or amenable to radiation therapy with curative intent or previously treated for advanced disease.

    Objectives: To compare the time to progression in patients with locally advanced or metastatic colorectal cancer (previously untreated for advanced disease) who receive OXAL + 5FU + CF or CPT-11 + OXAL (the two experimental regimens) to those receiving CPT-11 + 5-FU + CF (the control regimen). A secondary objective of this trial is to compare the time to progression of the patients receiving the two experimental regimens. Evaluation will be done of toxicity, response rate, time to treatment failure, survival, and quality-of-life parameters in patients on these regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00003594
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 16, 1999 Closing Date: July 19, 2002



    Permanently Closed
    CO23A Phase III Randomized Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma
    The purpose of this study is to find out whether it is better to receive a new drug, BBI608, or better to receive no further treatment for colon or rectal cancer.
    A Phase III Randomized Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma

    Complexity Level: 2

    Eligibility: Patients with pre-treated advanced colorectal carcinoma.

    Objectives: Primary Objective: -Overall Survival (OS) Secondary Objectives: -Progression-Free Survival (PFS) -Objective Response Rate (OR) -Disease Control Rate (DCR) -Safety profile -QoL, using the EORTC QLQ-C30 -HUI3, using the HUI3 index -Comparative economic evaluation -Exposure/response relationships of BBI608 using population PK -Association between putative biomarkers in tumour/blood & clinical benefit -Establish a comprehensive tumour bank linked to a clinical database

    NCT Registration ID (from clinicaltrials.gov): NCT01830621
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 2013 Closing Date: May 23, 2014



    Permanently Closed
    CO15 (C89803)A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC #616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil / Leucovorin Alone After Curative Resection for Patients with Stage III Colon Cancer
    This research is being done because patients with colon cancer who have surgery to remove their cancer are at risk for the cancer coming back. This risk can be reduced by giving chemotherapy after surgery. The purpose of this study is to determine which of the following treatment plans is more effective in preventing the return of colon cancer; a) A weekly schedule of Fluorouracil (5-FU) and Leucovorin (LV) over 32 weeks; b) A weekly schedule of Fluorouracil (5-FU) and Leucovorin (LV) plus Irinotecan (CPT-11) over 30 weeks.
    A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC #616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil / Leucovorin Alone After Curative Resection for Patients with Stage III Colon Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003835
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 25, 2000 Closing Date: May 11, 2001



    Permanently Closed
    CO16 (CR07)A Randomized Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer.
    The standard treatment for cancer of the rectum is to remove it surgically and this remains the most important part of any treatment. However, for some patients we know that the addition of radiotherapy to the area of the tumour in the pelvis can improve the outcome of the surgical treatment. The purpose of this study is to establish whether this radiotherapy is helpful for all patients with the same kind of disease that you have and whether radiotherapy should be given before or after surgery. This research is being done because we do not know which method of giving radiotherapy is better.
    A Randomized Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer.

    Complexity Level: 2

    Eligibility: Eligible patients have a histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumour within 15 cm of anal verge). The tumour must be considered potentially operable and patient must have no evidence of metastases.

    Objectives: The aim of this trial is to address the key question surrounding the use of radiotherapy in operable rectal cancer: Are local recurrence-free rates and quality of life optimized by giving all patients short course pre-operative radiotherapy, or is a preferable option to give post-operative chemoradiotherapy only to those at high risk of recurrence (i.e. with involved margins following surgery)?

    NCT Registration ID (from clinicaltrials.gov): NCT00003422
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 23, 2002 Closing Date: July 29, 2005



    Permanently Closed
    CO17 (CO17)A Phase III Randomized Study of Cetuximab (Erbitux TM, C225) and Best Supportive Care versus Best Supportive Care in Patients with Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR) - Positive Colorectal Carcinoma
    The purpose of the study is to compare the effects on colon cancer of a new drug, cetuximab, and best supportive care (BSC) compared to BSC alone.
    A Phase III Randomized Study of Cetuximab (Erbitux TM, C225) and Best Supportive Care versus Best Supportive Care in Patients with Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR) - Positive Colorectal Carcinoma

    Eligibility: Patients with pre-treated metastatic EGFR-positive colorectal carcinoma.

    Objectives: Primary To compare survival Secondary To compare the time to disease progression To compare the objective response rate To compare the quality of life in patients To conduct a comparative economic evaluation To evaluate the safety profile of cetuximab administered weekly

    NCT Registration ID (from clinicaltrials.gov): NCT00079066
    Participation: NCIC CTG and AGITG centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 28, 2003 Closing Date: August 26, 2005



    Permanently Closed
    CO20A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination with Cetuximab (Erbitux) Versus Placebo in Combination with Cetuximab (Erbitux) in Patients With K-Ras Wild Type Tumours Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma
    The purpose of this study is to find out whether it is better to receive a new drug, brivanib, in combination with cetuximab, or better to receive only cetuximab for colon or rectal cancer.
    A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination with Cetuximab (Erbitux) Versus Placebo in Combination with Cetuximab (Erbitux) in Patients With K-Ras Wild Type Tumours Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma

    Complexity Level: 2

    Eligibility: Patients with pre-treated metastatic K-Ras wild type colorectal carcinoma.

    Objectives: Primary To compare overall survival Secondary To compare progression-free survival To compare the objective response rate To compare the duration of response To compare the quality of life in patients To compare health utilities To conduct a comparative economic evaluation To evaluate the safety profile of cetuximab administered weekly and brivanib/placebo taken daily To examine molecular markers Banking of tissue

    NCT Registration ID (from clinicaltrials.gov): NCT00640471
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 05, 2008 Closing Date: February 10, 2011



    Permanently Closed

    Genito-urinary

    IDStudy TitleStatus
    PR21PLUDO (Prostate Lutetium/Docetaxel): A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

    PLUDO (Prostate Lutetium/Docetaxel): A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

    Complexity Level: 2

    Eligibility: Inclusion: 1. Progression on treatment with abiraterone and/or enzalutamide, or similar next generation androgen receptor (AR) targeted therapy 2.Evidence of PSMA positive metastatic disease, as assessed on PSMA-ligand PET/CT or PSMA-ligand PET/MR 3. Biopsy-proven prostate cancer with no evidence of small cell component 4. Prior orchiectomy, or if on LHRH agonist/antagonist then testosterone 5. Patients must have castration resistance with prior evidence of biochemical or imaging progression in the setting of surgical/medical castration

    Objectives: (Primary): To compare progression free survival (PFS) of patients with mCRPC following 177Lu-PSMA radioligand therapy vs. docetaxel in the post AR-targeted therapy setting (Secondary):proportion of patients that are progression free at 6 months (Secondary):overall survival (Secondary): proportions of patients with decreased PSA from baseline and the magnitude of change (Secondary):determine the clinical benefit rate (CBR), including partial response (PR), complete response (CR) or stable disease >24 weeks (RECIST v1.1). (Secondary):describe the adverse event (AE) profile of protocol therapy (Secondary):determine patient reported quality-of-life (QoL) while on treatment (Tertiary): explore biomarkers of response and resistance using cell free DNA (Tertiary): retrospectively explore a dosimetry-based approach to determine administered activity.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    PR22 (ANZUP 1801)Darolutamide Augments Standard Therapy for Localized High-Risk Cancer of the Prostate (DSAL-HiCaP)

    Darolutamide Augments Standard Therapy for Localized High-Risk Cancer of the Prostate (DSAL-HiCaP)

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    BL13A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer
    This study is looking at whether a new type of drug called durvalumab can be used in combination with the initial treatment patients receive. Recently, clinical trials have shown that a drug similar to durvalumab can help some patients with bladder cancer especially in combination with prior treatment.
    A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer

    Complexity Level: 2

    Eligibility: Histologic diagnosis of transitional cell carcinoma of the bladder with completion of prior trimodality therapy (surgery, chemotherapy and radiation)at least 42 days prior to study enrollment. Stage T2-T4a N0M0.

    Objectives: The overall objective of this phase II randomized trial is to determine if Durvalumab when used in combination following standard trimodality therapy improves disease-free-survival in patients with muscle-invasive bladder cancer who are electing for bladder-sparing treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT03768570
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 21, 2018



    Open to Accrual
    BLC4 (SWOG S1605)Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer
    Testing the use of Atezolizumab in Non-Muscle Invasive Bladder Cancer that has Not Responded to Prior Bacillus Calmette-Guerin (BCG) Therapy
    Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration. The carcinoma must be Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade. Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible. Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of carefor these patients. The reason for patients not to undergo cystectomy will be clearly documented.

    Objectives: Complete response at 25 weeks after registration for those with a CIS component; event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS)treated with atezolizumab. To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1). Progression-free survival, cystectomy-free survival,bladder cancer specific survival, overall survival in all patients.

    NCT Registration ID (from clinicaltrials.gov): NCT02844816
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: April 07, 2017



    Open to Accrual
    PNC1 (ECOG-ACRIN EA8134)InPACT: International Penile Advanced Cancer Trial
    Testing Combinations of Surgery, Chemotherapy, and Chemotherapy with Radiation for Cancer of the Penis that has Spread to Lymph Nodes
    InPACT: International Penile Advanced Cancer Trial

    Complexity Level: 2

    Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven squamous cell carcinoma of the penis. (3) Stage: any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0, OR; any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR; any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0, (4) Measurable disease as determined by RECIST (version 1.1) criteria, (5)Performance Status ECOG 0, 1 or 2, (6) Patient is fit to receive the randomisation options for which he is being considered. (7) adequate hematology, biochemistry, liver function, renal function tests, and patient must be suitable for randomization options. EXCLUSION: Pure verrucous carcinoma of the penis; Non-squamous malignancy of the penis; Squamous carcinoma of the urethra; Stage M1; Previous chemotherapy or chemoradiotherapy outside of the InPACT trial.

    Objectives: Primary objective: (1) (a) Is there a role for neoadjuvant therapy and, if so, (b) does CT or CRT produce superior outcomes (2) What is the additional survival benefit of PLND given after neoadjuvant s or with adjuvant CRT of the pelvic nodes over and above that of chemoradiotherapy alone in patients at high risk of recurrence following ILND? Secondary objectives: In InPACT-neoadjuvant: (a) Can neoadjuvant therapy prior to surgery (ILND) reduce recurrence rates? (b) Which is the more active of neoadjuvant CT or neoadjuvant CRT? (c) What is the op/post-op complication rate following neoadjuvant therapy of both types? (c) Is neoadjuvant CRT feasible in this setting? In InPACT-pelvis: (a) What is the rate of additional complications for the combination of PLND and CRT? Exploratory objectives: (a) What is the relationship between HPV status and outcome for all groups studied? (b) What is the impact on QOL of (sequential) treatments studied?

    NCT Registration ID (from clinicaltrials.gov): NCT02305654
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: May 30, 2018



    Open to Accrual
    REC3 (SWOG S1500)A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
    A Study testing Four Drugs (Cabozantinib, Crizotinib, Savolitinib, and Sunitinib) and their Effects on Advanced Kidney Cancer
    A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)

    Complexity Level: 2

    Eligibility: Patients must have histologically or cytologically confirmed papillary renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection. They must also have measurable disease (RECIST), they may have received prior therapy (up to one prior systemic therapy for advanced or metastatic renal cell carcinoma or prior radiation therapy), have a Zubrod PS of 0-1, have adequate hematologic and hepatic function, and be 18 years of age or older. Patients must have tissue available and be willing to submit for central pathologic review.

    Objectives: Primary Objective: To compare progression-free survival (PFS) in patients with mPRCC treated with sunitinib to PFS in patients with mPRCC treated with MET kinase inhibitors. Secondary Objectives: a. To compare RECIST response rate (RR; defined as the combined rate of confirmed and unconfirmed PR and confirmed and unconfirmed CR) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors. b. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors. c. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC. Translational Objectives: To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors

    NCT Registration ID (from clinicaltrials.gov): NCT02761057
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: July 27, 2016



    Open to Accrual
    REC4 (ECOG-ACRIN EA8143)A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
    A Study Comparing Surgery Alone to Surgery + Study Drug (Nivolumab) for Patients with Kidney Cancer
    A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

    Complexity Level: 2

    Eligibility: Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or unknown histology confirmed by biopsy for which radical or partial nephrectomay is planned. Patients must have no distant metastases, history of RCC within the past 5 years and have had no concurrent or prior systemic or local anti-cancer therapy for RCC. Paitents must be over the age of 18 and have no active or suspected autoimmune disease, no ongoing condition requireing systemic treatment with corticosteroids/other immunosuppressants and no history of severe hypersensitivity to a monoclonal antibody.

    Objectives: Primary Objective: To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. Secondary Objectives: To evaluate for differences in RFS associated with perioperative nivolumab compared to surgery alone among patients with clear cell histology. To compare the overall survival between the two arms. To describe the safety and tolerability of perioperative nivolumab.

    NCT Registration ID (from clinicaltrials.gov): NCT03055013
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: October 31, 2018



    Open to Accrual
    PR20A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]
    Comparing standard treatment to standard treatment plus ablative therapy (radiation or surgery) to all sites of disease for patients with hormone sensitive oligometastatic prostate cancer.
    A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]

    Complexity Level: 2

    Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven oligometstatic adenocarcinoma of the prostate and no evidence of small cell cancer, (3) Stage: IV (newly diagnosed at presentation or relapse after curative intent therapy); M1 disease with 12 months & 36 mo. max duration; recurrent/metstatic disease previously treated with systemic or radiation therapy; Castration resistant prostate cancer (per PCWG3); Untreated pelvic lymph nodes as only site of disease; inability to treat all sites of disease with LAT; parenchymal brain mets.

    Objectives: Primary objective: To compare failure free survival between patients with oligometastatic HSPC treated with standard systemic therapy plus ablative therapy to untreated prostate primary in patients with low volume metastatic disease burden versus standard systemic therapy plus local ablative therapy to all sites of disease. Secondary objectives: Radiographic Progression Free Survival; Incidence of new metastases as first event; Overall survival; Ablative treatment related adverse events (grade 3 or greater); Quality of Life (QOL); Economic analysis. Tertiary objectives: Correlative exploratory studies such as immunophenotyping to understand mechanisms of resistance to SBRT when added to standard systemic therapy and identify predictive/prognostic markers in the trial population, and to create a biorepository of tissue and blood for future correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT03784755
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: April 18, 2019



    Open to Accrual
    PR19A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
    The purpose of this study is to evaluate high dose rate (HDR) and low dose rate (LDR) brachytherapy given as monotherapy with respect to tumour control, toxicity, quality of life, and economic impact.
    A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

    Complexity Level: 1

    Eligibility: Patients enrolled in this study must have histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months and have low- (clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL) or intermediate-risk (clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and < 50% of positive cores) prostate cancer.

    Objectives: Primary objective: prostate cancer control as defined by 48 month PSA values Secondary objectives: Disease-free survival, acute and long term toxicity and safety, Quality of Life (QOL) of the patient and their spouse/partner, resource utilization and economic indices of treatment administration. Tertiary objective: To establish a comprehensive tumour bank linked to a clinical database for the further study of predictive and prognostic biomarkers in prostate cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT02960087
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: November 04, 2016



    Open to Accrual
    BL12A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen
    The purpose of this study is to compare the effects of nab-paclitaxel to paclitaxel to treat this disease. This research is being done because currently there is no effective treatment for urothelial cancer that has progressed after prior chemotherapy.
    A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have histologically or cytologically confirmed diagnosis of transitional cell carcinoma of the urinary tract (bladder, urethra, ureter, renal pelvis) and metastatic or locally advanced inoperable disease extent (T4, N2, N3 or M1 disease).

    Objectives: Primary Objective: progression free survival (PFS) Secondary Objectives: objective response rates (ORR), clinical benefit rate (CBR), time to response and response duration, safety, QOL, and health analysis Exploratory Objectives: Correlative Biology, Health and Demographic Assessment

    NCT Registration ID (from clinicaltrials.gov): NCT02033993
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: January 27, 2014 Closing Date: April 06, 2017



    Closed to Accrual
    PRC4 (ALLIANCE A031201)Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
    This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone acetate, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.
    Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

    Complexity Level: 2

    Eligibility: Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.

    Objectives: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer treated with either enzalutamide only or enzalutamide with abiraterone and prednisone. To assess the toxicity profile and compare safety by treatment arm, to assess and compare post-treatment PSA declines by treatment arm, to compare radiographic progression free survival and objective response rate by treatment arm, to test for radiographic progression free survival treatment interaction in predicting overall survival, to assess pre- and post-treatment measures of tumor burden and bone activity using PET/CT and bone scintigraphy and correlate these measures with overall survival, and to develop and validate prognostic and predictive models of overall survival.

    NCT Registration ID (from clinicaltrials.gov): NCT01949337
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 27, 2014 Closing Date: August 31, 2016



    Closed to Accrual
    REC2 (ECOG E2805)ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
    Most patients with cancer usually have surgery to remove the tumour and then must undergo chemotherapy in an effort to stop the cancer from coming back in a more aggressive form (called recurrence). For kidney cancer patients who are at a high risk for recurrence, it is not yet known which drugs work best to prevent recurrence. Therefore the purpose of this study is to determine if either the drug Sunitinib or the drug Sorafenib might be beneficial to patients who have recently undergone surgery to remove their kidney cancer. This trial is designed in a double blind fashion, meaning that patients will not know which treatment they are receiving. One third will receive sunitinib, one third will receive sorafenib, and one third will receive a placebo (a substance that does not do anything).
    ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

    Complexity Level: 2

    Eligibility: Patients with primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent.

    Objectives: Primary: To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients receiving Sunitinib vs Sorafenib vs placebo after radical or partial nephrectomy. Secondary: To compare overall survival of patients randomized to each of the two regimens with placebo, to further define toxicity of prolonged administration of study agents and to collect biological specimens to assess their characteristics and associations.

    NCT Registration ID (from clinicaltrials.gov): NCT00326898
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 14, 2006 Closing Date: September 02, 2010



    Closed to Accrual
    PRC3 (CALGB C90203)A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.
    The purpose of this study is to compare the effects (good and bad) of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove the prostate) with radical prostatectomy alone in patients with high risk prostate cancer to see which is better. Men who have prostate cancer that meets certain criteria are called "high risk" which means that there is a good chance that their prostate cancer will come back even after their prostate is removed. It is believed that a certain combination of drugs (docetaxel and LHRH agonists) that are usually used to treat advanced prostate cancer, will actually be beneficial if used before the prostate is removed, and before the cancer has the chance to grow into a more aggressive and problematic disease.
    A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.

    Complexity Level: 2

    Eligibility: Patients with High-Risk, Clinically Localized Prostate Cancer.

    Objectives: PSA Free Survival 3 Years Post Op; Compare 5-year bPFS, Disease Progresssion; Disease Free Survival and Overall Survival; Difference in Pathologic Stage; Safety and Tolerability; Correlative Studies: Diet and lifestyle; Frozen Tissue and Paraffin Blocks for Biomarker Analyses, Expression Profiling, chromosomal Gain or Loss Analysis

    NCT Registration ID (from clinicaltrials.gov): NCT00430183
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 15, 2007 Closing Date: October 02, 2015



    Closed to Accrual
    PR13 (MRC PR10)RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery.
    The standard of care for patients with prostate cancer is to undergo surgery to remove the prostate. Some patients then go on to receive radiation therapy and hormone therapy in an effort to stop the cancer from returning in a more aggressive form. It is unknown whether it is best to receive radiotherapy immediately after surgery or only when there is evidence (via blood tests) that the cancer has returned. Similarly, following radiotherapy, it is unknown how long horomone therapy should be given to patients, or even if it should be given at all. This trial involves multiple randomizations and is designed to answer these very important questions.
    RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery.

    Complexity Level: 2

    Eligibility: Men who have undergone radical prostatectomy for prostateic adenocarcinoma within 3 months. RT Timing Randomization: Post-opterative serum PSA less than 0.4 ng/mL. Uncertainty in the opinon of the physician and patient regarding the need for immediate post-operative RT. Hormone Duration Randomization: Post-opterative serum PSA less than 10 ng/mL. Patient is due to receive post-operative RT either adjuvant or salvage.

    Objectives: Disease free survival; Freedom from treatment failure; Clinical progression-free survival; Overall survival; Non-protocol hormone therapy Quality of life; Treatment toxicity

    NCT Registration ID (from clinicaltrials.gov): NCT00541047
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 27, 2007 Closing Date: December 30, 2016



    Closed to Accrual
    PR17 (ANZUP 1304)Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
    The purpose of this study is to determine the effectivetness of enzalutamide (a more potent and effective androgen receptor blocker), compared to conventional non-steroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide), when combined with a luteinising hormone releasing hormone analogue (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for metastatic prostate cancer. You may be eligible for this trial if you aged 18 years or above and have prostate cancer that has spread beyond your prostate but are otherwise in relatively good health. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants randomised to Group 1 will receive Enzalutamide daily, and patients randomised to Group 2 will receive Conventional NSAA. Both treatments are taken by mouth and will continue until your disease worsens or if you have side effects. Both groups will also be treated with a LHRHA or surgical castration.
    Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

    Complexity Level: 2

    Eligibility: Men starting first line androgen deprivation therapy for metastatic adenocarcinoma of the prostate. Key eligibility criteria include metastatic prostate cancer, adequate organ function and ECOG performance status 0-2.

    Objectives: Primary endpoint: Overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT02446405
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 02, 2015 Closing Date: March 24, 2017



    Closed to Accrual
    BLC1 (SWOG S1011)A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer
    This randomized phase III trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.
    A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer

    Complexity Level: 2

    Eligibility: Patients must have histologically-proven (T2, T3, or T4a) urothelial carcinoma of the bladder (UCB) that requires primary radical cystectomy for definitive treatment.

    Objectives: Primary: To compare disease-free survival (DFS) in eligible patients treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Secondary: To compare overall survival (OS) between extended PLND versus standard pelvic lymphadenectomy. To evaluate operative time, whether nerve sparing was performed, morbidity and mortality, length of hospital stay, histology, lymph node counts density, adjuvant chemotherapy, and local and retroperitoneal soft tissue recurrence. Proximal extent of node dissection in those patients randomized to extended PLND will be evaluated as well. Translational Medicine Objectives: a. To bank paraffin embedded blocks or slides of the primary tumor, b. To determine the prognostic value of putative markers of the premetastatic niche, c. To evaluate if the prevalence of pre-metastatic niche is different between patients that received neoadjuvant chemotherapy and those who did not.

    NCT Registration ID (from clinicaltrials.gov): NCT01224665
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 15, 2014 Closing Date: February 15, 2017



    Closed to Accrual
    BL10 (4B951)MVAC in Organ-Confined Bladder Cancer Based on p53 Status.
    The purpose of this study is to evaluate the effects (good or bad) of treament with M-VAC in patients who have had their bladder cancer removed by surgery. The usual treatment after surgery is close observation without additional therapy.
    MVAC in Organ-Confined Bladder Cancer Based on p53 Status.

    Eligibility: Patients who have undergone a radical cystectomy and bilateral pelvic lymphadenectomy

    Objectives: To compare the recurrence free and overall survival of those patients with alterations in the p53 gene who are treated with MVAC to patients with tumours demonstrating p53 alterations who are observed. To compare the recurrence free and overall survival prospectively of patients with tumours demonstrating alterations in p53 who are observed to patients with no p53 alterations who are also observed. To examine the expression of p53 and other genes, particularly RB, p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy. To study the association of p53 mutational gene status with p53 proteinexpression by IHC, outcome (recurrence-free and overall survival).

    NCT Registration ID (from clinicaltrials.gov): NCT00005047
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 22, 2003 Closing Date: March 28, 2006



    Permanently Closed
    PR10C (Z0071)Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy

    Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy

    Eligibility: Must be randomized to PR.10

    Objectives: To obtain quality of life information.

    NCT Registration ID (from clinicaltrials.gov): NCT00052481
    Participation: Patients randomized to PR.10
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 19, 2003 Closing Date: April 09, 2004



    Permanently Closed
    PR15Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
    Feasibility study in intermediate risk prostate cancer radiotherapy treatments.
    Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

    Complexity Level: 1

    Eligibility: . Histologically confirmed CaP . PSA < 20 ng /ml . TNM classification . T2b to T2c, GS < 8/10 or . T1c-T2a GS 7/10 or . T1c-T2a, GS less than or equal to 6/10, 10 less than or equal to PSA < 20 . Prostate volume less than or equal to 75 cc

    Objectives: Primary: The primary objective of this feasibility study is to assess the ability of Canadian investigators from multiple institutions to randomize patients to curative intent IGRT or IGRT with HDR brachytherapy boost. Secondary: Acute GU and GI adverse events; Quality assurance; Treatment compliance

    NCT Registration ID (from clinicaltrials.gov): NCT01982786
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 05, 2013 Closing Date: September 30, 2015



    Permanently Closed
    PR6Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain

    Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain

    NCT Registration ID (from clinicaltrials.gov): NCT00003232
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 24, 1997 Closing Date: May 14, 2001



    Permanently Closed
    PR1Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate

    Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1979 Closing Date: May 26, 1981



    Permanently Closed
    BL2The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer

    The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 18, 1981 Closing Date: October 15, 1982



    Permanently Closed
    BL3NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder

    NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 03, 1985 Closing Date: April 19, 1989



    Permanently Closed
    BL1A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer

    A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 20, 1979 Closing Date: September 01, 1980



    Permanently Closed
    PR8 (SWOG S9346)Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.
    The purpose of this study is to determine how well patients respond to different methods of giving treatment with an LHRH analogue in combination with an antiandrogen drug for the treatment of prostate cancer. Quality of life and the development of side effects are important in assessing this treatment.
    Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.

    Complexity Level: 2

    Eligibility: Patients with histologically or cytologically confirmed adenocarcinoma of the prostate, clinical stage D2 as evidenced by soft tissue and/ or bony metastases.

    Objectives: To compare survival and quality of life in patients randomized to either intermittent or continuous combined androgen deprivation therapy (CAD).

    NCT Registration ID (from clinicaltrials.gov): NCT00002651
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 19, 1998 Closing Date: August 31, 2008



    Permanently Closed
    REC1 (CALGB C90206)A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer

    A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer

    Complexity Level: 2

    Eligibility: Patients with advanced renal cell cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00072046
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 23, 2004 Closing Date: July 01, 2005



    Permanently Closed
    BL4 (E5886)A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer

    A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 30, 1986 Closing Date: May 15, 1989



    Permanently Closed
    PRP1BAn Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product
    The purpose of these studies is to better understand the nature of high grade prostatic intraepithelial neoplasia and to determine how subjects respond to treatment with vitamin E, selenium and soy protein product.
    An Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product

    Eligibility: Subjects who have met the eligibility criteria for and were previously enrolled in the NCIC CTG PRP.1 study: A double-blind, placebo-controlled, randomized study of combination vitamin E, selenium and soy protein product in subjects with high grade prostatic intraepithelial neoplasia.

    Objectives: To determine if molecular, genetic and immunohistochemical markers are associated with progression from high grade PIN to cancer. To determine if molecular or immunohistochemistry changes can occur in PIN among men treated with combination vitamin E, selenium and soy compared to placebo. To determine if cancers that arise within the PRP.1 study differ in terms of their proliferative capacity as measured by nuclear factor kappa B, p27 and ki-67, and to bank biopsy material, serum and DNA for future studies.

    Participation: Limited to subjects enrolled on the PRP.1 study.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 29, 2005 Closing Date: April 17, 2009



    Permanently Closed
    PRP1A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia
    The purpose of this study is to see if soybean product plus vitamin E and selenium can prevent the development of prostate cancer in men with PIN cells. To do this, half of the subjects in the study will receive a nutritional supplement containing soybean product, vitamin E and selenium and the other half will receive a placebo (a substance that does not do anything).
    A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia

    Eligibility: Documented high grade prostatic intraepithelial neoplasia (HGPIN) confirmed by the central reference pathologist. Two prostate biopsies performed within 18 months of randomization with the most recent within 6 months of randomization. Both biopsies must be negative for invasive prostate cancer.

    Objectives: To compare disease free survival, changes in serum PSA, oxidative biomarkers and hormone levels with nutrient supplement, containing vitamin E, selenium and soy protein, or placebo. To determine the association between prostate cancer development and exposure to various hypothesized risk factor for prostate cancer and to evaluate the safety of the treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT00064194
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 28, 2001 Closing Date: July 23, 2004



    Permanently Closed
    PRC2 (CALGB C90202)A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
    The purpose of this study is to compare the effects (good and bad) of early treatment with zoledronic acid compared to standard treatment with zoledronic acid. To do this, half of the patients in this study will get zoledronic acid and the other half will receive a placebo (a substance that does not do anything). This research is being done because we know that treatment with zoledronic acid decreases the risk of certain skeletal (bone) related risks in men with prostate cancer after the cancer has spread to the bones. The cancer continues to grow even with hormonal therapy (standard treatment). This research is being done because we do not know whether earlier treatment with zoledronic acid (started before the cancer grows with hormonal therapy) is better or worse than standard treatment.
    A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

    Complexity Level: 2

    Eligibility: 1) Histologic documentation of prostate adenocarcinoma. 2) At least one bone metastasis by radiographic imaging 3) While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. 4) No prior treatement with bisphosphonates. 5) No prior treatment with radiation and hormones as sepcified in section 5.4 of the protocol. 6) ECOG (CTC) performance status 0-2. 7) Min. Age 18. 8) Baseline laboratory data should fall within protocol required limits.

    Objectives: Primary objective: To determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. Secondary objective: To determine whether treatment with zoledronic acid will decrease the proportion of men with one or more vertebral fractures at two years compared to placebo in men receiving androgen deprivation therapy for metastatic prostate cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00079001
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 07, 2006 Closing Date: April 02, 2012



    Permanently Closed
    PR9 (P-0011)Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy

    Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy

    Eligibility: Patients will have pathologic stage T3N0M0 prostate cancer at high-risk for PSA relapse as determined by GS > 7 and one or more of the following: 1) preoperative PSA > 10 ng/ml; 2) positive surgical margins; 3) seminal vesicle invasion. If Gleason score < 7, then two or more of the above factors. Patients who have negative LN status by lymph node sampling or LN dissection will be eligible. If pathologic LN status is unknown, the risk of involvement must be less than 5 % as determined by the Roach formula.

    Objectives: To test, in a randomized study, if the addition of androgen suppression to radiation therapy in patients with unfavorable pathologic stage pT3N0M0 prostate cancer leads to better outcome than each used separately. The endpoints will be overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure. To compare the qualitative and quantitative toxicities of patients with pT3N0M0 prostate cancer treated adjuvantly with androgen suppression and radiation therapy to that of adjuvant radiation therapy or androgen suppression alone.

    NCT Registration ID (from clinicaltrials.gov): NCT00023829
    Participation: Limited to centres with a current CPA/FWA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 25, 2004 Closing Date: May 07, 2004



    Permanently Closed
    PR7 (PR7)A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
    This research study will compare continuous hormone treatment to intermittent hormone treatment to determine if intermittent treatment is as effective and if it improves quality of life. At this time, no one knows which treatment may be better for me.
    A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients who completed radiotherapy to the prostate more than a year ago and who have a rising PSA > 3 ng/ml and higher than the lowest level since the end of radiotherapy without other evidence of metastasis.

    Objectives: Comparisons of overall survival, time to the development of hormone resistance, quality of life, serum cholesterol and HDL/LDL levels. Evaluate duration of treatment and non-treatment intervals, time to testosterone recovery and time to recovery of potency.

    NCT Registration ID (from clinicaltrials.gov): NCT00003653
    Participation: Limited to centres with current CPA #.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 05, 1999 Closing Date: November 30, 2005



    Permanently Closed
    PR5 (PR5)A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

    A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 14, 1995 Closing Date: September 15, 1998



    Permanently Closed
    PR3 (PR3)Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate
    The purpose of this study is to determine which of the treatments is most effective in prolonging life and giving patients with this stage of prostate cancer the best possible quality of life.
    Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate

    Eligibility: Patients with adenocarcinoma of the prostate who have performance status of 0-2, adequate blood counts and liver and kidney function, and no contraindication to pelvic radiotherapy.

    Objectives: To evaluate any benefit from the addition of radiation therapy to the treatment of the patients with cancer of the prostate who are receiving hormonal therapy in terms of overall survival, time to progression, symptomatic local control, and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00002633
    Participation: Limited to North America centres with current CPA/FWA#; all MRC - UK centres.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 08, 1995 Closing Date: August 31, 2005



    Permanently Closed
    PR2 (8794)Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy

    Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 22, 1990 Closing Date: January 01, 1997



    Permanently Closed
    PR12Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART)
    This study looks at men with prostate cancer that are at high risk of the disease returning. The purpose of this study is to compare the effects, on prostate cancer, of a chemotherapy drug (Docetaxel) given with the standard treatment compared to the standard treatment alone. The standard treatment for this cancer is hormone therapy and local radiation therapy.
    Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART)

    Eligibility: Patients with histologically proven, localized (NO, M0) adenocarcinoma of the prostate with adverse prognostic features which are considered to be high risk for recurrence based on the presence of at least one of the following features: T stage > or = to 3a, Gleason Score > or = 8 or presenting PSA>20

    Objectives: The primary objective is to compare disease free survival rates in men treated with androgen suppression therapy and radiation therapy followed by androgen suppression therapy with or without neoadjuvant docetaxel. Secondary objectives include overall survival, degree of PSA suppression prior to radiation therapy and Quality of Life.

    NCT Registration ID (from clinicaltrials.gov): NCT00651326
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 03, 2008 Closing Date: November 12, 2009



    Permanently Closed
    PR11A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)
    This study examines whether or not men with newly diagnosed cancer of the prostate should immediately undergo surgery or radiation therapy as opposed to actively monitoring the disease and treating only if the cancer gets worse. It is believed that many men suffer the side effects of radical treatments, when their cancer in fact has a very small chance of ever causing any problems. Currently, there are excellent, non-invasive tools for accurately monitoring prostate cancer progression, which may potentially be used to determine when and if radical therapy is required. For more information, please view our Patient Educational Video at the following web link: http://www.ctg.queensu.ca/trials/start/start.html
    A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)

    Complexity Level: 2

    Eligibility: Histologically confirmed adenocarcinoma of the prostate that is negative for metastasis. Patient is a suitable candidate for radical prostatectomy or radiotherapy. No previous treatment for prostate cancer for greater than 6 months. Patient has been classified as favourable risk as defined by the following: clinical stage T1b, T1c, T2a or T2b, surgical Gleason score <= 6, PSA <= 10.0 ng/ml. For more information, please view our Patient Educational Video at the following web link: http://smaug/trials/start/start.html

    Objectives: To compare disease specific survival in patients with favourable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis to active surveillance and selective intervention based on pre-specified biochemical, histological or clinical criteria.

    NCT Registration ID (from clinicaltrials.gov): NCT00499174
    Participation: Not limited
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 2007 Closing Date: May 13, 2011



    Permanently Closed
    PR10 (Z0070)Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

    Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

    Eligibility: Patients must have a PSA of < 10 ng/ml. Patients must have histologically proven clinical stage T1c (usually impalpable) or T2a (unilaterally abnormality, papable or visible on TRUS), N0, M0 adenocarcinoma of the prostate, diagnosed within 120 days prior to registration on this study. Note: bilateral palpable disease is not allowed.

    Objectives: To ascertain whether patients assigned to receive brachytherapy have equal or better overall survival as compared to patients randomized to receive radical prostatectomy. To compare the two treatment arms with respect to: metastasis-free survival, the probability of survival without symptoms, side effects from the intervention and Quality of Life addressed in the companion study.

    NCT Registration ID (from clinicaltrials.gov): NCT00023686
    Participation: Limited to centres with a current CPA/FWA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 19, 2002 Closing Date: April 09, 2004



    Permanently Closed
    BL7 (30987)Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy
    The purpose of this study is to compare the effects (good and bad) on patients with this type of urothelial cancer of a drug called Paclitaxel in addition to standard treatment (Gemcitabine and Cisplatin), to the standard treatment alone to see which is better.
    Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy

    Eligibility: Patients with locally advanced and/or metastatic cell carcinoma of the urothelium who have not had prior systemic therapy. Patients must have histologically proven stage IV locally advanced disease (T4b, N0-N1) or metastatic ((N2N3 or M10 transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter and renal pelvis. Patients should not be suitable for surgery or radiation with curative intent. However, patients whose pre-chemotherapy sites of disease are restricted to the primary or regional lymph node sites and who have had a major response to chemotherapy will be evaluated for post-chemotherapy surgical resection of residual cancer if the tumour has become resectable at the end of chemotherapy.

    Objectives: The primary objective of this trial is to compare two treatment groups, cisplatin/ gemcitabine and cisplatin/ gemcitabine/ paclitaxel, with respect to the duration of survival. Secondary objectives are to compare in the two treatment groups the: 1) duration of progression-free survival 2) response rates (RECIST) 3)duration of response. Also to compare and characterize the nature of the toxicity experienced in each arm.

    NCT Registration ID (from clinicaltrials.gov): NCT00022191
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 11, 2001 Closing Date: June 01, 2004



    Permanently Closed
    BL8 (30994)Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.
    The purpose of this study is to compare the effects (good and bad) of giving chemotherapy soon after surgery (within 90 days) to delaying chemotherapy until cancer comes back to see which is better. Preliminary studies have suggested that chemotherapy may be helpful in delaying or preventing recurrence after removal of the bladder. However, other studies have also shown that late chemotherapy can be helpful in putting the cancer back into remission, and we are not yet sure which is the best strategy for treatment.
    Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.

    Complexity Level: 2

    Eligibility: Patients with histologically proven transitional cell carcinoma (TCC) of the bladder (pT2 incidental pT3 or pT4) and/or node positive (pN1-3) M0 TCC following radical cystectomy and lymphadenectomy. Lymph node dissection of 15 or more lymph nodes is recommended. Patients must be able to start chemotherapy within 90 days after surgery.

    Objectives: To compare the survival of patients with T3-T4 or N+ bladder cancer after radical cystectomy when treated with immediate adjuvant chemotherapy versus chemotherapy at relapse; to compare the progression-free survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00028756
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 11, 2001 Closing Date: May 09, 2008



    Permanently Closed
    BL5 (BA06)A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder

    A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 02, 1990 Closing Date: June 01, 1995



    Permanently Closed
    BL11A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder
    The purpose of this study is to compare the effects on you and your superficial bladder cancer of a new drug Iressa? given with another commonly-used treatment to treat this disease. This research is being done because superficial bladder cancer often comes back after surgery. Iressa? has been shown to shrink cancer in animals. It is not clear, however, if it can offer better results when it is given together with intravesical BCG (BCG vaccine that is put into the bladder) compared to BCG put into the bladder alone. The combination of BCG put into the bladder and Iressa? has not been studied before.
    A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder

    Eligibility: Patients with high risk Ta, Tis or T1 superficial bladder cancer, who completed transurethral resection of all visible bladder lesions within 21 to 60 days prior to randomization, and without other evidence of metastasis.

    Objectives: Comparisons of time to treatment failure, complete response rate for patients with carcinoma in situ (Tis) at randomization, time to recurrence, time to progression, overall survival, adverse event and safety, and quality of life. Evaluate prognostic significance of tumour marker expression on the primary tumour and impact of therapy on tumour marker expression.

    NCT Registration ID (from clinicaltrials.gov): NCT00352079
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 12, 2006 Closing Date: December 04, 2008



    Permanently Closed

    Gynecologic

    IDStudy TitleStatus
    ENC1 (NRG GY018)A Randomized Phase III Study of Carboplatin and Paclitaxel with or without Pembrolizumab for Measurable Stage 3 or 4A, Stage 4B or Recurrent Endometrial Cancer

    A Randomized Phase III Study of Carboplatin and Paclitaxel with or without Pembrolizumab for Measurable Stage 3 or 4A, Stage 4B or Recurrent Endometrial Cancer

    Complexity Level: 2

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    OV26 (CRUK/UCL ICON9)An International Phase III Randomised Study to Evaluate the Efficacy of Mantenance Therapy with Olaparib and Cediranib or Olaparib Alone in Patients with Relapsed Platinum-sensitive Ovarian Cancer Following a Response to Platinum-Based Chemotherapy

    An International Phase III Randomised Study to Evaluate the Efficacy of Mantenance Therapy with Olaparib and Cediranib or Olaparib Alone in Patients with Relapsed Platinum-sensitive Ovarian Cancer Following a Response to Platinum-Based Chemotherapy

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    CX5 (CX5)A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients with Low-Risk Early Stage Cervical Cancer. (SHAPE)
    The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.
    A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients with Low-Risk Early Stage Cervical Cancer. (SHAPE)

    Complexity Level: 1

    Eligibility: Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist.

    Objectives: Evaluate whether treatment with radical hysterectomy and pelvic node dissection is non-inferior to treatment with simple hysterectomy and pelvic node dissection in terms of pelvic-relapse free survival. Compare the rates of treatment-related toxicity, extrapelvic relapse-free survival, and overall survival. Compare rates of sentinel node detection, and rates of parametrial, margins and pelvic nodes involvement Compare quality of life (including sexual health)

    NCT Registration ID (from clinicaltrials.gov): NCT01658930
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Open to Accrual
    Activation Date: August 02, 2012



    Open to Accrual
    OVC2 (NRG GY005)A Randomized Phase II/III study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)
    The purpose of this study is to find out whether it is better to receive a combintaion of two new drugs,olaparib and cediranib, or either drug alone, compared to the usual chemotherapy for the recurrent platinum-resistant or -refractory ovarian cancer
    A Randomized Phase II/III study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

    Complexity Level: 2

    Eligibility: women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer

    Objectives: Primary Objective: To assess the efficacy and identify (in)active arm(s) of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by PFS in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. Secondary Objectives: - To assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by RECIST criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. - To assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events

    NCT Registration ID (from clinicaltrials.gov): NCT02502266
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: January 19, 2017



    Open to Accrual
    OV25A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs)
    The purpose of this phase II trial is to find out whether asprin can prevent or reduce the risk of early ovarian cancer in women at high risk for ovarian cancer.
    A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs)

    Complexity Level: 2

    Eligibility: Women with documented germline BRCA 1/2 mutations, scheduled to undergo risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) within 6 months to 2 years after the date of randomization.

    Objectives: PRIMARY OBJECTIVE: To compare the frequency of pre- & early-malignant lesions (serous tubal intraepithelial carcinomas (STICs) or serous tubal occult neoplasias - early (STONEs) in the fallopian tube, at the time of risk reducing surgery. SECONDARY OBJECTIVE: To assess subject acceptance of ASA intervention in a female cohort at high risk for ovarian cancer. TERTIARY OBJECTIVES: (1) To characterize the effect of ASA on high grade serous ovarian cancer (HGSOC) tumourigenesis and to examine the linkage between tumourigenesis and microenvironment. (2) Biobanking for future correlative studies

    NCT Registration ID (from clinicaltrials.gov): NCT03480776
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: April 06, 2018



    Open to Accrual
    EN7 (DCGOG PORTEC-3)Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.
    The purpose of this study is to look at whether the benefits of radiotherapy treatment can be improved by adding chemotherapy. Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there are good scientific reasons from early clinical studies why this combination should work on endometrial cancer cells, it has not yet been tested in a large number of women with endometrial cancer. For this reason, some women will receive standard radiotherapy alone and some women will receive the new combination of radiotherapy with chemotherapy. Another purpose of this study is to find out whether the chemotherapy lengthens the effectiveness of radiotherapy, without producing side effects that interfere too much with day to day life. In order to study this we need to conduct a randomized controlled trial.
    Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.

    Complexity Level: 2

    Eligibility: Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO 2009 stages; confirmed at pathology review: Stage IA with myometrial invasion, grade 3 with documented lymph-vascular space invasion (LVSI); Stage IB grade 3; Stage II; Stage IIIA or IIIC; or IIIB if parametrial invasion; Stage IA with myometrial invasion, IB, II or IIIA/C with serous or clear cell histology.

    Objectives: Overall and failure free survival; toxicity; Quality of Life; Pelvic and distant recurrence; Translational studies on paraffin fixed tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT00411138
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 03, 2008 Closing Date: December 20, 2013



    Closed to Accrual
    OVC1 (NRG GY004)A Phase III Study Comparing Single-agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-based Chemotherapy in Women with Recurrent Platinum-sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
    The purpose of this phese 3 study is to find out whether it is better to receive a new drug olaparib alone, or the combination of two new drugs, olaparib and cediranib, compared to the usual standard chemotherapy forplatinum-sensitive recurrent ovarian cancer
    A Phase III Study Comparing Single-agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-based Chemotherapy in Women with Recurrent Platinum-sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Complexity Level: 2

    Eligibility: women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer

    Objectives: Primary Objective: Assess the efficacy of either single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer. Secondary Objectives:Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by response rate, and overall survival as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT02446600
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 04, 2017 Closing Date: November 10, 2017



    Closed to Accrual
    CX1A Phase II Study to Evaluate the Toxicity and Efficacy of Concurrent Cisplatin and Radiation Therapy in the Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Cervix

    A Phase II Study to Evaluate the Toxicity and Efficacy of Concurrent Cisplatin and Radiation Therapy in the Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Cervix

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1990 Closing Date: April 12, 1991



    Permanently Closed
    CX2A Phase III Study Comparing Concurrent Cisplatin and Radiation Therapy versus Radiation Alone for Locally Advanced Squamous Cell Carcinoma of the Cervix

    A Phase III Study Comparing Concurrent Cisplatin and Radiation Therapy versus Radiation Alone for Locally Advanced Squamous Cell Carcinoma of the Cervix

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 12, 1991 Closing Date: September 30, 1996



    Permanently Closed
    GT1 (0174)A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia
    The purpose of this study is to compare the effects (good and bad) of methotrexate compared to dactinomycin on GTN. This research is being done because we do not know which of these two commonly-used treatments is better.
    A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia

    Eligibility: Patients with untreated, histologically confirmed low risk GTN (persistent hydatidform mole or choriocarcinoma). Patients must have a pretreatment WHO score of 0 - 6 and a GOG performance status of 0 - 2.

    Objectives: To determine whether weekly parenteral methotrexate or "pulsed" dactinomycin is the more effective treatment for low risk gestational trophoblastic neoplasia. To prospectively determine and compare the toxicity of each regimen. To prospectively determine whether the definition of persistent GTN is accurate.

    NCT Registration ID (from clinicaltrials.gov): NCT00003702
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 18, 2000 Closing Date: February 26, 2007



    Permanently Closed
    OV12A Phase III Comparison of BAY 12-9566 versus Placebo as Consolidation After Standard Chemotherapy in Patients with Epithelial Ovarian Cancer

    A Phase III Comparison of BAY 12-9566 versus Placebo as Consolidation After Standard Chemotherapy in Patients with Epithelial Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 06, 1998 Closing Date: September 20, 1999



    Permanently Closed
    OV14 (OC9804)An International Randomized Phase III Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) versus Paclitaxel/Carboplatin (TC) in the Initial Treatment of Women with Advanced Ovarian Cancer
    The purpose of this study is to find out if chances for cure and for a good quality of life are improved by adding Epirubicin the combination of Carboplatin and Paclitaxel.
    An International Randomized Phase III Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) versus Paclitaxel/Carboplatin (TC) in the Initial Treatment of Women with Advanced Ovarian Cancer

    Eligibility: Patients with a clinical diagnosis consistent with FIGO Stage IIB-IV invasive epithelial ovarian, fallopian tube or peritoneal cancer.

    Objectives: Primary: Progression-free survival Secondary: Overall survival, Compare the relative toxicity of the two regimens and analysis of Quality of Life.

    NCT Registration ID (from clinicaltrials.gov): NCT00004934
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 14, 1999 Closing Date: July 31, 2001



    Permanently Closed
    OV16 (OV16)A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer
    The main purpose of this research study is to find out if first line treatment with four cycles of cisplatin combined with topotecan followed by another four cycles of paclitaxel combined with carboplatin will cause the tumour to shrink at least as well as, if not better than, standard treatment of paclitaxel combined with carboplatin given for eight cycles.
    A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer

    Complexity Level: 2

    Eligibility: Patients with confirmed epithelial ovarian (or primary fallopian or peritoneal) cancer, Stage IIB to IV, with microscopic or macroscopic residual disease who have not received prior chemotherapy and have evidence of adequate organ function.

    Objectives: Primary: to compare progression free survival. Secondary: to compare overall survival, response rates, toxic effects, quality of life, and CA 125 normalization rates.

    NCT Registration ID (from clinicaltrials.gov): NCT00028743
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 31, 2001 Closing Date: June 29, 2005



    Permanently Closed
    CX3A Phase III Randomized Study of Cisplatin Alone versus a Combination of Etoposide, Ifosfamide and Cisplatin (VIP) in the Treatment of Persistent, Recurrent or Advanced Squamous or Adenosquamous Cell Carcinoma of the Cervix

    A Phase III Randomized Study of Cisplatin Alone versus a Combination of Etoposide, Ifosfamide and Cisplatin (VIP) in the Treatment of Persistent, Recurrent or Advanced Squamous or Adenosquamous Cell Carcinoma of the Cervix

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 16, 1992 Closing Date: November 19, 1993



    Permanently Closed
    OV4Third Cooperative Clinical Trial on Treatment of Advanced Ovarian Carcinoma

    Third Cooperative Clinical Trial on Treatment of Advanced Ovarian Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 08, 1980 Closing Date: March 31, 1984



    Permanently Closed
    OV8Clinical Trial Examining the Treatment of Patients With Macroscopic Residual Epithelial Ovarian Carcinoma. Part I - The Comparison of Cyclophosphamide and Cisplatin Versus Cyclophosphamide and Carboplatin as Initial Treatment Part II - The Comparison of Whole Abdominal Radiation versus Continuing Chemotherapy in Patients on Part I of the Study

    Clinical Trial Examining the Treatment of Patients With Macroscopic Residual Epithelial Ovarian Carcinoma. Part I - The Comparison of Cyclophosphamide and Cisplatin Versus Cyclophosphamide and Carboplatin as Initial Treatment Part II - The Comparison of Whole Abdominal Radiation versus Continuing Chemotherapy in Patients on Part I of the Study

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 07, 1985 Closing Date: March 17, 1989



    Permanently Closed
    OV2A Clinical Trial of Radiotherapy and Chemotherapy With Melphalan Following Surgery for Patients With Limited (Stage I, II & IIIo) Carcinoma of the Ovary

    A Clinical Trial of Radiotherapy and Chemotherapy With Melphalan Following Surgery for Patients With Limited (Stage I, II & IIIo) Carcinoma of the Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 20, 1975 Closing Date: March 31, 1984



    Permanently Closed
    OV1Treatment of Patients With Advanced Ovarian Carcinoma (Stages III and IV) With Melphalan, 5 Fluorouracil and Methotrexate in Combination and Sequentially

    Treatment of Patients With Advanced Ovarian Carcinoma (Stages III and IV) With Melphalan, 5 Fluorouracil and Methotrexate in Combination and Sequentially

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1974 Closing Date: March 07, 1977



    Permanently Closed
    OV21 (OV21)A Phase II Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy.
    There are two main reasons why this study is being done. The first reason is to see if in patients who first receive chemotherapy, followed by surgery and then need more chemotherapy, whether this post-surgery chemotherapy is best given as IP treatment or as IV treatment. The second reason for the study is to find out whether it is better to give IP treatment with carboplatin or cisplatin.
    A Phase II Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy.

    Complexity Level: 1

    Eligibility: Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Carcinoma

    Objectives: 9 month progression rate following randomization Progression-Free Survival, Overall Survival, Toxic Effects, Quality of Life

    NCT Registration ID (from clinicaltrials.gov): NCT00993655
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 11, 2009 Closing Date: May 27, 2015



    Permanently Closed
    OV19 (MRC ICON7)A Randomized, Two-Arm, Multi-Center Gynecologic Cancer Intergroup Trial of Adding Bevacizumab To Standard Chemotherapy (Carboplatin And Paclitaxel) In Patients With Epithelial Ovarian Cancer.
    The purpose of this study is to compare the effects a new drug, bevacizumab, given together with standard drugs (carboplatin and paclitaxel), which are commonly-used to treat this disease, versus being given the standard drugs alone, on you and your ovarian cancer. This research is being done because we do not know which of these two commonly-used treatments is better. Bevacizumab has been shown to improve survival in colon (bowel) cancer patients. In ovarian cancer it has been shown to shrink tumours in some women with recurrent disease, but it is not clear if it can improve the outcome of treatment in newly diagnosed ovarian cancer patients when it is added to standard chemotherapy. This study will answer that question.
    A Randomized, Two-Arm, Multi-Center Gynecologic Cancer Intergroup Trial of Adding Bevacizumab To Standard Chemotherapy (Carboplatin And Paclitaxel) In Patients With Epithelial Ovarian Cancer.

    Complexity Level: 2

    Eligibility: ICON7 will include patients with newly diagnosed, histologically confirmed, high risk FIGO stage I and IIa (Grade 3 or clear cell carcinoma only) and FIGO stage IIb - IV (all grades and all histological types) epithelial ovarian, fallopian tube or primary peritoneal cancer, who have undergone initial surgery (either debulking cytoreductive surgery or a biopsy if the patient has FIGO stage IV disease) and who will not be considered for cytoreductive surgery prior to disease progression. Patients with measurable and non-measurable disease (see Appendix 10) are eligible.

    Objectives: Primary: Progression-free survival. Secondary: Overall survival, Response rate (rate and duration), Adverse events, Quality of Life, Health Economics and Translational Research.

    NCT Registration ID (from clinicaltrials.gov): NCT00483782
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 19, 2007 Closing Date: February 13, 2009



    Permanently Closed
    OV18 (MRC ICON6)A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (with platinum-based chemotherapy) and Concurrent and Maintenance Cediranib in Women with Platinum-sensitive Relapsed Ovarian Cancer
    The purpose of this study is to investigate whether we can improve the benefits of chemotherapy treatment by adding a new drug called cediranib (AZD2171). Chemotherapy is the name for drug treatments to kill or control the growth of cancer cells. Although there are good scientific reasons from laboratory studies why cediranib (AZD2171) should work on ovarian cancer cells, it has not yet been tested in a large number of women with ovarian cancer. Some early clinical studies have shown that cediranib (AZD2171) does have an effect on tumours, but we don't yet know whether the drug will be effective in treating ovarian cancer and, if it does work, for how long treatment should continue. For this reason, some women will receive standard chemotherapy drugs alone; some women will receive the new drug (cediranib) during chemotherapy; and, some women will receive the new drug (cediranib) during and after chemotherapy, for up to 18 months in total.
    A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (with platinum-based chemotherapy) and Concurrent and Maintenance Cediranib in Women with Platinum-sensitive Relapsed Ovarian Cancer

    Complexity Level: 2

    Eligibility: Patients with relapsed epithelial ovarian, fallopian tube or primary serous peritoneal carcinoma who require platinum-based chemotherapy for first relapse 6 or more months after the last dose of first-line platinum-based therapy.

    Objectives: Primary: Overall Survival, Progression-free survival and tolerability. Secondary: Toxicity, Quality of Life, Health Economics and Molecular Biology.

    NCT Registration ID (from clinicaltrials.gov): NCT00532194
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 02, 2008 Closing Date: December 14, 2011



    Permanently Closed
    OV17 (CALYPSO)A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (Caelyx) and Carboplatin vs. Paclitaxel and Carboplatin in Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months): GCIG Calypso Study
    This international study is being carried out on behalf of the Gynecological Cancer InterGroup (GCIG) under the sponsorship of the French group named 'Association de Recherche sur les Cancers Gynecologiques' (ARCAGY) with the support of Schering-Plough Corporation who will supply the study treatment, liposomal doxorubicin (marketed under the name of Caelyx). This study is part of an ongoing effort to develop better treatments for patients with ovarian cancer. The study will compare the standard treament of paclitaxel and carboplatin agaist an experimenal arm of caelyx and carboplatin.
    A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (Caelyx) and Carboplatin vs. Paclitaxel and Carboplatin in Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months): GCIG Calypso Study

    Complexity Level: 2

    Eligibility: Epithelial cancer of the ovary in progression > 6 months (late relapse) after a first or a second line including a platinum-derivative. Patients should have received previously a taxane.

    Objectives: Primary objective: Progression-free survival (PFS) between both treatment groups Secondary objectives Overall survival (OS) Toxicities Quality of life (QOL)

    NCT Registration ID (from clinicaltrials.gov): NCT00189553
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 17, 2005 Closing Date: September 25, 2007



    Permanently Closed
    OV7Clinical Trial Comparing Abdominal-Pelvic Radiation versus Cyclophosphamide and Cisplatin Chemotherapy in Patients With Epithelial Ovarian Carcinoma Having Only Microscopic Residual Disease Following Surgery

    Clinical Trial Comparing Abdominal-Pelvic Radiation versus Cyclophosphamide and Cisplatin Chemotherapy in Patients With Epithelial Ovarian Carcinoma Having Only Microscopic Residual Disease Following Surgery

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 29, 1985 Closing Date: March 16, 1988



    Permanently Closed
    EN1Chemotherapy of Stage IV Metastatic and Recurrent Carcinoma of the Uterine Corpus

    Chemotherapy of Stage IV Metastatic and Recurrent Carcinoma of the Uterine Corpus

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 06, 1975 Closing Date: November 11, 1980



    Permanently Closed
    OV8APilot Study of Cyclophosphamide and Cisplatin in Patients With Ovarian Cancer

    Pilot Study of Cyclophosphamide and Cisplatin in Patients With Ovarian Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 03, 1984 Closing Date: May 06, 1985



    Permanently Closed
    OV11 (9619)A Phase II Trial of Intraperitoneal Cisplatin and Intravenous and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian Cancer

    A Phase II Trial of Intraperitoneal Cisplatin and Intravenous and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 1996 Closing Date: May 15, 1998



    Permanently Closed
    OV6Non-Randomized Study to Determine the Efficacy of Surgery Alone in Patients With Stage IA Or IB Epithelial Ovarian Carcinoma When Extensive Surgical Staging Has Been Done to Confirm Limited Disease

    Non-Randomized Study to Determine the Efficacy of Surgery Alone in Patients With Stage IA Or IB Epithelial Ovarian Carcinoma When Extensive Surgical Staging Has Been Done to Confirm Limited Disease

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 10, 1984 Closing Date: March 18, 1988



    Permanently Closed
    OV9A Multicentre, Randomized Comparative Study of Taxol in Platinum Treated Ovarian Cancer (High vs. Low Dose; Long vs. Short Infusion)

    A Multicentre, Randomized Comparative Study of Taxol in Platinum Treated Ovarian Cancer (High vs. Low Dose; Long vs. Short Infusion)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 06, 1991 Closing Date: March 06, 1992



    Permanently Closed
    OV5APilot Study of Weekly Adriamycin and Cisplatinum With Co-Trimoxazole Coverage in Patients With Stage III And IV Ovarian Cancer

    Pilot Study of Weekly Adriamycin and Cisplatinum With Co-Trimoxazole Coverage in Patients With Stage III And IV Ovarian Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 22, 1983 Closing Date: May 01, 1984



    Permanently Closed
    OV3Second Co-operative Clinical Trial on Treatment of Ovarian Carcinoma

    Second Co-operative Clinical Trial on Treatment of Ovarian Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 16, 1978 Closing Date: May 14, 1979



    Permanently Closed
    OV15 (OVAR 2.5)International Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients with Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy
    The purpose of this study is to compare the effects on you and your ovarian cancer of a drug carboplatin given alone compared to carboplatin given with a newer drug, gemcitabine. This research is being done because we do not know which of these two treatments is better.
    International Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients with Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy

    Eligibility: Patients with histologically proven ovarian carcinoma with evidence of recurrence or progression, which is not amenable to curative surgery or radiotherapy. Patients must have failed first-line platinum-containing therapy more than 6 months after treatment discontinuation.

    Objectives: To compare the time to progressive disease (TTPD) in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. The secondary objectives of this study are to compare the following in the two arms: response rate, duration of response, survival time, toxicity, and changes in quality of life over time.

    NCT Registration ID (from clinicaltrials.gov): NCT00006453
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 17, 2000 Closing Date: April 15, 2002



    Permanently Closed
    OV13 (EORTC 55971)An International Multi-Centre Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
    The main purpose of this study is to find out what is the best sequence of these 2 treatment modalities (surgery and chemotherapy). The first possibility (A) is to give first 3 courses of chemotherapy followed by the surgical removal of the tumours in the abdomen, and then again followed by at least 3 courses of chemotherapy. The second possibility (B) is to try to remove the tumours in the abdomen first, then followed by at least 6 courses of chemotherapy, with or without interval debulking surgery. It is the purpose of this study to find out if the chances for definitive cure, for complications of the treatment and for a good quality of life are improved by changing the sequence of the treatment.
    An International Multi-Centre Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed stage IIIc or IV epithelial ovarian, peritoneal or fallopian tube carcinoma with a performance status of < 2 (WHO), adequate blood counts and liver and renal function.

    Objectives: To compare overall survival; to evaluate the differences in progression free survival, toxicity and tolerability and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00003636
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 13, 1999 Closing Date: November 30, 2006



    Permanently Closed
    OV10 (55931)Intergroup Phase III Comparison of a Combination of TAXOL-Platinum and a Combination of Cyclophosphamide-Platinum Chemotherapy in the Treatment of Advanced Epithelial Ovarian Cancer.

    Intergroup Phase III Comparison of a Combination of TAXOL-Platinum and a Combination of Cyclophosphamide-Platinum Chemotherapy in the Treatment of Advanced Epithelial Ovarian Cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 03, 1994 Closing Date: July 31, 1995



    Permanently Closed
    EN4 (55874)Intergroup (EORTC, NCIC CTG) Phase III Study to Evaluate the Role of Adjuvant Radiotherapy in the Treatment of Uterine Sarcomas Stages I and II

    Intergroup (EORTC, NCIC CTG) Phase III Study to Evaluate the Role of Adjuvant Radiotherapy in the Treatment of Uterine Sarcomas Stages I and II

    NCT Registration ID (from clinicaltrials.gov): NCT00002459
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 26, 1995 Closing Date: August 10, 2001



    Permanently Closed
    EN5A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium
    The purpose of this study is to compare treatment with surgery alone to treatment with radiation therapy added to the surgery. This will determine whether the addition of radiation therapy to surgery will indeed improve the outlook of patients even further. Another aim of this study is to look at a number of tests on the cancer tissue to see whether we can determine the behaviour of the cancer.
    A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium

    Eligibility: Patients with histologically confirmed adenocarcinoma of the endometrium (Stage IA [grade 3] or IB [grade 3] or IC [grade 1 or 2 or 3]) or stage IIA treated by total abdominal hysterectomy with bilateral salpingo-oophorectomy who have not received prior pelvic radiotherapy. Patients may receive first-line brachytherapy (if local standard).

    Objectives: In collaboration with the MRC UK ASTEC trial analysis, to compare overall survival; to evaluate the differences in recurrence-free survival, duration of pelvic control and toxicity and tolerability. Canadian components to analyse quality of life and sexual health.

    NCT Registration ID (from clinicaltrials.gov): NCT00002807
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 1996 Closing Date: March 31, 2005



    Permanently Closed
    CXC1 (0219)A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage 1B2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis.
    The purpose of this study is to compare the effects on the patient and their cervical cancer of a new drug tirapazamine given together with radiation and cisplatin compared to treatment with radiation and cisplatin, which is the commonly-used treatment for this disease. This research is being done to determine if combining tirapazamine (TPZ) with cisplatin during radiation therapy increases progression-free survival (PFS) compared with cisplatin and radiation therapy alone. Tirapazamine is an investigational agent.
    A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage 1B2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis.

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed invasive squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix stages IB2, IIA, IIB, IIIB or IVA.

    Objectives: To determine if combining TPZ with cisplatin during radiation therapy increases recurrence-free survival(RFS) when compared with weekly cisplatin and radiation therapy in this patient population.

    NCT Registration ID (from clinicaltrials.gov): NCT00262821
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 2006 Closing Date: September 01, 2009



    Permanently Closed
    CX4 (0191)Phase III trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/L with Erythropoietin Versus Above 100 g/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer
    The purpose of this study is to find out if raising your hemoglobin level with Eprex will improve the outcome of cervix cancer, as compared to the standard treatment which is given without Eprex, where transfusions may be used if necessary to maintain the hemoglobin.
    Phase III trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/L with Erythropoietin Versus Above 100 g/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer

    Complexity Level: 2

    Eligibility: Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage II-B, III-B, IV-A.

    Objectives: To assess the efficacy of raising and maintaining patient hemoglobin level above 120 g/L using erythropoietin compared to maintenance level above 100 g/L without erythropoietin on progression-free survival, overall survival and local control in anemic patients with carcinoma of the cervix receiving concurrent radiation and cisplatin treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT00017004
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 19, 2001 Closing Date: January 17, 2004



    Permanently Closed

    Head And Neck

    IDStudy TitleStatus
    HNC2 (NRG HN004)Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin
    Comparing Radiation Plus Antibody Therapy to Radiation Plus Immune Therapy in People With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
    Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

    Complexity Level: 2

    Eligibility: Eligibility Criteria include: p16 and PD-L1 status by submission of tissue samples, pathologically confirmed, previously untreated, unresected squamous cell carcinoma of larynx, hypopharynx, oropharynx, oral cavity or unknown head and neck primary within 60 days of registration (locoregionally advanced HNSCC), contraindication to cisplatin, adequate hematological hepatic and renal function, negative pregnancy test (if applicable)

    Objectives: Phase II: Primary objective is PFS. Phase III: Primary objective is OS. Secondary objectives include: Toxicity profile, effects of anti-PD-L1 therapy, OS, response, loco-regional failure, distant metastasis, and competing mortality, Quality of Life, swallowing related QoL and performance, gastronomy tube retention Exploratory objectives include: immune response, short term QoL, short term swallowing related QoL, patient reported fatigue, and health utilities

    NCT Registration ID (from clinicaltrials.gov): NCT03258554
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    HN10A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients with Low-risk HPV-related Oropharyngeal Squamous Cell Carcinoma
    This is a phase II, single arm, open-label, multi-centre cooperative group trial of elective volume adjusted de-escalation radiotherapy in patients with low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC).
    A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients with Low-risk HPV-related Oropharyngeal Squamous Cell Carcinoma

    Complexity Level: 2

    Eligibility: Patients with pathologically proven diagnosis of HPV-related OPSCC. Clinical stage T1-3 N0-1 M0. Patients must be eligible for definitive RT or CRT, >= 18 years of age, ECOG 0-2. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. Patients must be accessible for treatment and follow up.

    Objectives: Primary Objective: To evaluate the efficacy of primary definitive radiotherapy (RT) or chemoradiotherapy (CRT) utilizing volume reduced elective nodal irradiation (ENI) as measured by 2-year progression-free survival (PFS) in patients with low-risk HPV-related OPSCC. Secondary Objectives: To evaluate other metrics for efficacy and safety, early and late toxicities of treatment, objective swallowing and salivary functions, quality of life (QOL), utilization of healthcare resources, work productivity, and prognostic biomarkers. Tertiary Objectives: To assemble an imaging and biospecimen bank for future research that could improve risk stratification and patient selection for volume-reduced ENI.

    NCT Registration ID (from clinicaltrials.gov): NCT03822897
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: February 20, 2019



    Open to Accrual
    HN9Randomized Phase II Study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)
    Immunotherapy is a new type of treatment strategy for many different cancer types. Two types of new immunotherapy drugs are called durvalumab and tremelimumab. Laboratory tests show that these drugs work by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. The HN.9 study tests how well four different treatment strategies (three of which include immunotherapy) work for patients with advanced, HPV-positive, head and neck cancer that has not spread to other areas. The four treatment strategies are 1) radiation therapy (RT) and durvalumab (given at the same time) followed by durvalumab alone; 2) RT and durvalumab (given at the same time) followed by durvalumab and tremelimumab; 3) RT and durvalumab (given at the same time); 4) RT and a standard chemotherapy drug called cisplatin (given at the same time). Note: the fourth option does not include immunotherapy.
    Randomized Phase II Study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)

    Complexity Level: 2

    Eligibility: 1) Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oropharynx (OSCC) which is locoregionally advanced, intermediate risk and non-metastatic (M0) as defined by the following: - T1-2 N2b (smoking >10 pack-years) - T3 N0-N2b (smoking >10 pack-years) - T1-3 N2c (any smoking history) 2) Human papillomavirus (HPV)-related as determined by positive p16 immunohistochemical staining on any tumoural specimens. 3) Performance status of 0 or 1. 4) > 18 years of age. 5) Patient must consent to release of tumour tissue, blood, saliva and throat swab samples for correlative studies. 6) Adequate normal organ and marrow function.

    Objectives: Primary: To estimate the efficacy (in terms of event-free survival) of 3 treatment Arms: (A) radiotherapy (RT) and cisplatin; (B) RT and durvalumab followed by adjuvant durvalumab; and (C) RT and durvalumab followed by adjuvant durvalumab and tremelimumab in patients with intermediate risk, HPV-positive, locally advanced oropharyngeal squamous cell carcinoma of the head and neck (LA-OSCC). Secondary: 1) To assess differences between arms in change in FACT-HN score from baseline to 36 months post-RT; 2) To estimate and describe the following in each of the 3 treatment arms: Locoregional control; Distant metastasis-free survival (DMFS); OS; Toxicity; Incidence of second cancer; Dysphagia; PRO-CTCAE Radiation related late toxicity; Cost effectiveness; Cost utility; and lost productivity. Tertiary: 1) Correlative Studies; 2) Event-free survival as defined by iRECIST.

    NCT Registration ID (from clinicaltrials.gov): NCT03410615
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: January 31, 2018



    Open to Accrual
    HN2A Double-Blind Phase III Randomized Study of Bacitracin, Clotrimazole, Gentamicin (Bcog) Lozenges versus Placebo Lozenges for Radiation-Associated Mucositis in Head and Neck Cancer

    A Double-Blind Phase III Randomized Study of Bacitracin, Clotrimazole, Gentamicin (Bcog) Lozenges versus Placebo Lozenges for Radiation-Associated Mucositis in Head and Neck Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 22, 1997 Closing Date: July 30, 1999



    Permanently Closed
    HN3A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
    The purpose of the study is to find out whether giving the radiotherapy treatment in the morning (between 8 and 10 AM) or giving the same treatment in the late afternoon (between 4 and 6 PM) causes the same degree of mucositis. To do this, half of the patients in the study will get the treatments in the morning and the other half will get the treatments in the afternoon.
    A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck

    Eligibility: Patients with squamous cell carcinoma of the oral cavity, pharynx (oro, hypo and naso), or larynx, who are to receive radiation treatment to a significant part of the oral and/or pharyngeal mucosa where the reaction will be visible.

    Objectives: To compare the toxicity of radiotherapy to the oral mucosa delivered in the morning and the late afternoon; to compare grades and duration of mucositis, incidence of clinically significant mucositis using a validated mucositis scoring system, treatment days lost because of treatment reactions, incidence of late toxicity, changes in body weight, complete response rates, survival and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00004234
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 02, 1999 Closing Date: November 15, 2004



    Permanently Closed
    HN1A Phase III Study Evaluating the Role of Elective Neck Dissection in the Management of Oral Carcinoma

    A Phase III Study Evaluating the Role of Elective Neck Dissection in the Management of Oral Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 17, 1995 Closing Date: May 08, 1998



    Permanently Closed
    HN4A Phase II Study of Cisplatin and Gemcitabine in Patients with Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumours
    The purpose of this study is to find out what effects a new drug combination, cisplatin or carboplatin in combination with gemcitabine, has on you and your salivary gland tumour. This research is being done because currently there is no treatment that can cure this type of cancer and these drugs seem promising when tested in a small number of people with salivary gland tumours.
    A Phase II Study of Cisplatin and Gemcitabine in Patients with Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumours

    Eligibility: Patients will have documented evidence of locally advanced recurrent and/or metastatic malignant salivary gland tumours deemed to be incurable by surgery or radiation. Patients may have had up to one prior chemotherapy regimen for locally advanced recurrent/metastatic disease provided that it was non cisplatin/carboplatin or gemcitabine containing and at least 4 weeks have elapsed since chemotherapy discontinuation and study registration. Adjuvant chemotherapy (including cisplatin or carboplatin based regimens) is allowed provided that a minimum of 12 months has elapsed.

    Objectives: Primary: To estimate the activity of combination cisplatin (or carboplatin) and gemcitabine among patients with malignant salivary gland tumours which are locally recurrent or metastatic. Secondary: Measurement of complete response Measurement of duration of response Assessment of the toxicity profile of the combination regimen Measurement of overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT00079079
    Participation: Limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 23, 2003 Closing Date: May 05, 2008



    Permanently Closed
    HN5A Phase I Study of Adjuvant OSI-774 (Tarceva) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
    This is a study assessing the effects of OSI-774 in people with cancer of the head and neck. The purpose of this study is to evaluate the side effects, drug levels and tumour effects of OSI-774 and to determine the best dose of OSI-774 to use for future studies. This is done by starting at a dose lower than the one found effective in previous studies. Patients are given OSI-774 and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study at a higher dose of OSI-774. If the side effects are severe, then more patients are asked to join the study at a lower dose of OSI-774. Patients joining the study later on will get a higher dose of OSI-774 (TarcevaTM) than patients who join earlier. This is a part of the study plan to see which dose is better tolerated in patients.
    A Phase I Study of Adjuvant OSI-774 (Tarceva) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

    Eligibility: Patients with locally advanced squamous cell carcinoma of the head and neck (stages III, IVA or IVB) post treatment with combined chemo-radiotherapy (cisplatin based). Patients must have no evidence of disease or presence of inoperable minimal residual disease at the time of registration.

    Objectives: To evaluate the toxicity and determine the recommended dose of OSI-774. To evaluate the effect(s) of OSI-774 on plasma and urinary angiogenic factors (specifically VEGF, VEGFR, VEGFR2, bFGF levels) before, during and after therapy. To correlate angiogenic factor levels with initial blood vessel concentration in the tumour and with the presence or absence of EGFRvIII mutation. To document disease free survival (DFS).

    NCT Registration ID (from clinicaltrials.gov): NCT00079053
    Participation: Limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 05, 2003 Closing Date: March 31, 2008



    Permanently Closed
    HN6A Phase III Study Of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab In Patients With Locally Advanced Stage III And IV Squamous Cell Carcinoma Of The Head And Neck.
    The purpose of this study is to compare the effects of accelerated radiotherapy with the drug panitumumab compared to standard radiotherapy with cisplatin chemotherapy. This research is being done because panitumumab and accelerated radiotherapy are promising treatments for head and neck cancer. We do not know if this may be better, the same, or worse at controlling the cancer than standard treatment. Panitumumab is a type of antibody therapy which acts against a protein on tumour cells called the epidermal growth factor receptor. Panitumumab belongs to a class of drugs call "EGFR inhibitors". Other EGFR inhibitors similar to panitumumab have been shown to slow the growth of head and neck cancer when combined with radiotherapy. Panitumumab has been shown to slow the growth of advanced colon cancer.
    A Phase III Study Of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab In Patients With Locally Advanced Stage III And IV Squamous Cell Carcinoma Of The Head And Neck.

    Complexity Level: 1

    Eligibility: Patients with histologically confirmed squamous cell carcinoma of the head and neck of the oral cavity, oropharynx, larynx or hypopharynx which is locally advanced as defined by TanyN+M0 or T3-4N0M0.

    Objectives: The primary objective is progression free survival. The secondary objectives include: overall survival, local progression free survival, regional progression free survival, distant metastasis, acute and late adverse events, quality of life, swallowing related quality of life, functional swallowing outcome (selected centres), significance of tissue and blood biomarkers, and health economics.

    NCT Registration ID (from clinicaltrials.gov): NCT00820248
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 18, 2008 Closing Date: November 07, 2011



    Permanently Closed

    Hematologic

    IDStudy TitleStatus
    ALC5 (SWOG S1612)A Randomized Phase II/III Trial of Novel Therapeutics versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome, Aged 60 or Older (LEAP, Intergroup Less Intense AML Platform Trial)
    This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitidine, decitabine, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer cells.
    A Randomized Phase II/III Trial of Novel Therapeutics versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome, Aged 60 or Older (LEAP, Intergroup Less Intense AML Platform Trial)

    Complexity Level: 1

    Eligibility: Patients, who are 60 years and older, must have morphologically confirmed previously untreated acute myelogenous leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2) with no known AML in the CNS. The disease must be present in the blood or bone marrow and those patients with only extramedullary disease in the absence of bone marrow or blood involvement will not be eligible. Patients with acute promyelocyctic leukemia (APL), biphenotypic leukemia, blastic transformation of chronic myelogenous leukemia (CML or BCR/ABL), are not eligible. Investigator must determine that patients are ineligible for intensive induction therapy or the patient must have refused intensive induction therapy. Patients must not have active autoimmune disease that has required systemic treatment in the past 2 years.

    Objectives: Primary Objective Based on overall survival, to select for the phase II component any or all of the "novel therapeutic" regimens for further testing. In the phase III component, to compare overall survival of the "novel therapeutic" regimens selected in the phase II portion of the trial to azacitidine in these patient populations. Secondary objectives To estimate the frequency and severity of toxicities of the regimens in these patient populations. To estimate response rates, event-free survival, and relapse-free survival for these regimens in these patient populations. Additional Objectives To investigate associations between cytogenetic and molecular abnormalities (including FLT3) and outcomes of each of the regimens in these patient populations To bank specimens for future correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT03092674
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    HD10 (NCRI (UK))A Randomized Phase III Trial with a PET Response Adapted Design Comparing ABVD +/- ISRT with A2VD +/- ISRT in Patients with Previously Treated Stage IA/IIA Hodgkin Lymphoma (RADAR)

    A Randomized Phase III Trial with a PET Response Adapted Design Comparing ABVD +/- ISRT with A2VD +/- ISRT in Patients with Previously Treated Stage IA/IIA Hodgkin Lymphoma (RADAR)

    Complexity Level: 2

    Eligibility: Patients, 16-69 years old, may be enrolled in this study if they have histologically confirmed stage I or II classical Hodgkin lymphoma with no mediastinal bulk disease or B symptoms. Patients must have ECOG status of 0 to 2.Patients must not have received prior treatment for Hodgkin lymphoma, but should be fit to receive anthracycline-based chemotherapy. Patient must have the following lab values: creatinine clearance >40 ml/min, total bilirubin <1.5 x ULN, ALT or AST <2 x ULN, haemoglobin > or equal to 8g/dL, neutrophils > or equal to 1.0 x109/l, and platelets > or equal to 100 x109/l. Patients are excluded if they have nodular lymphocyte Hodgkin lymphoma, other cancer diagnosed within last 5 years with exceptions, or recurrent of persistent other cancer within last 5 years. Patients are excluded if there is an absence of FDG-avid lymphoma lesions on baseline PET scan, or they have a pre-existing grade > or equal to 1 sensory or motor peripheral neuropathy.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    HDC1 (SWOG S1826)A Phase III Randomized Study of Nivolumab (Opdivo) or Brentuximab Vedotin (Adcetris) plus AVD in Patients (age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

    A Phase III Randomized Study of Nivolumab (Opdivo) or Brentuximab Vedotin (Adcetris) plus AVD in Patients (age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

    Complexity Level: 2

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    CL4Randomized Phase II Evaluation of Lower-dose (3-2-1 strategy) vs Full Dose of Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia

    Randomized Phase II Evaluation of Lower-dose (3-2-1 strategy) vs Full Dose of Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    HEM1A Single-arm, Multicentre Trial of Decentralized CD19 CAR T-cell Manufacturing and Therapy in Patients with Relapsed/Refractory Agressive B-cell Lymphoma or B-cell Actue Lymphoblastic Leukemia

    A Single-arm, Multicentre Trial of Decentralized CD19 CAR T-cell Manufacturing and Therapy in Patients with Relapsed/Refractory Agressive B-cell Lymphoma or B-cell Actue Lymphoblastic Leukemia

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    MY12A MULTICENTER SINGLE ARM PHASE II STUDY OF IXAZOMIB, DARATUMUMAB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE FOR PREVIOUSLY UNTREATED, TRANSPLANT INELIGIBLE MULTIPLE MYELOMA
    A study of chemotherapy using ixazomib, daratumumab, cyclophosphamide and dexamethasone for patients with multiple myeloma
    A MULTICENTER SINGLE ARM PHASE II STUDY OF IXAZOMIB, DARATUMUMAB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE FOR PREVIOUSLY UNTREATED, TRANSPLANT INELIGIBLE MULTIPLE MYELOMA

    Complexity Level: 1

    Eligibility: Newly diagnosed, transplant-ineligible patients with multiple myeloma. Patients must have a diagnosis of active multiple myeloma as per the IMWG criteria and have measurable disease. No prior myeloma treatment is allowed.

    Objectives: Primary Objective is to assess the overall response rate (ORR) after 24 cycles of ixazomib, cyclophosphamide, dexamethasone and daratumumab (ICDD) in newly diagnosed, transplant-ineligible multiple myeloma patients. Secondary objectives include, depth of response, clinical benefit rate, ORR after 4 cycles, progression free survival, overall survival, safety and tolerability, rate of MRD negativity at 2 years with FDG-PET, multiparameter flow cytometry (MFC) and immunoglobulin gene sequencing (IgS) using current IMWG criteria and PFS in the subset of standard risk, MRD-negative patients who de-escalate therapy after 24 cycles. Tertiary Objective includes correlative science, quality of life, health economics and clinical frailty.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    LY18A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma
    This is an unblinded (open-label) multi-centre randomized phase I trial of novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma, conducted by the NCIC CTG. The study will open with one cohort. Additional cohorts may be added in future as separate appendices, through protocol amendment. There will be no randomization.
    A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma

    Complexity Level: 2

    Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at most recent relapse, with clinically and/or radiologically measureable disease. Patients with de novo aggressive B-cell lymphoma must have relapsed or progressed, or have biopsy proven refractory disease, after one prior line of therapy (R-CHOP chemotherapy or equivalent). Patients with histological transformation from low-grade lymphoma may have had up to 3 prior treatment regimens. Patients with transformed low grade lymphoma treated with a non-anthracycline regimen may be enrolled at investigator discretion Patients must be 16 years old or older, must have had at least one previous regimen of therapy for their disease, and must be considered fit for intensive chemotherapy and ASCT. Patients must have a life expectan

    Objectives: The primary objective is to establish the recommended phase II dose of new combination therapy in individuals with relapsed and refractory lymphoma. Secondary objectives include determining the overall response rate using RECIL response criteria, evaluating the tolerability and toxicity, determining the stem cell collection rate and transplantation rate. An exploratory objective is to assess molecular factors, which may be prognostic or predictive of response.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    ALC4 (ECOG E1910)A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.
    This study is being done to determine what effects (good and bad) the investigational drug blinatumomab has on the sub-type of B-lineage ALL called BCR-ABL-negative.
    A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.

    Complexity Level: 1

    Eligibility: Adults aged 30-70 years with confirmed new diagnosis of BCR-ABL negative, B-lineage ALL.

    Objectives: Primary: to evaluate the overall survival associated with blinatumomab Secondary: minimal residual disease assessment; toxicities associated with treatment; outcome of blood/marrow transplant with or without blinatumomab; incidence of anti-blinatumomab antibody formation

    NCT Registration ID (from clinicaltrials.gov): NCT02003222
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 24, 2017



    Open to Accrual
    ALC6 (ALLIANCE A041501)A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (A Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL
    This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
    A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (A Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL

    Complexity Level: 1

    Eligibility: Patients who are 18 to 39 years old and are newly diagnosed with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible for this study. Patients with Burkitt type ALL or who have BCR-ABL fusion transcript determined by FISH or RT-PCR or t(9;22)(q34;q11) by cytogenetics are not eligible. No prior therapy is allowed for ALL except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. Patients must complete remission induction therapy and have M2 marrow or better by the time of randomization.

    Objectives: To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS), without censoring for transplant. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response.To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved, with censoring for transplant.To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.To determine the prognosis based on patients' LDA gene signature. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the regimen used in CALGB 10403.

    NCT Registration ID (from clinicaltrials.gov): NCT03150693
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: April 12, 2019



    Open to Accrual
    LY17A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma
    This is an unblinded (open-label) multi-centre randomized phase II trial of novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma, conducted by the NCIC CTG. The trial will open as a two arm comparison of Ibrutinib plus Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (R-GDP) versus R-GDP alone. The primary endpoint for the trial is overall response rate. Up to sixty-four patients will be accrued to each arm, with interim analyses scheduled when 16 and 32 patients have been enrolled. Individuals will be randomly assigned to initial therapy. Those with responsive disease will go on to receive autologous stem cell transplant (ASCT). The purpose of this randomized phase II "pick the winner" design is to facilitate efficient screening of novel combination treatment regimens and select those meeting pre-specified criteria for testing in the phase III setting. This study will also allow us to evaluate the predictive value of a number of biomarkers
    A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

    Complexity Level: 2

    Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as transformed previousl indolent lymphoma and unclassifiable B-cell lymphoma), with clinically and/or radiologically measureable disease. Patients must be 16 years old or older, must have had at least one previous regimen of therapy for their disease, and must be considered fit for intensive chemotherapy and ASCT. Patients must have a life expectancy of >90 days, and a performance status of 3 or less. Specific laboratory requirements also apply.

    Objectives: To determine the overall response rate (complete and partial response) to novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma.

    NCT Registration ID (from clinicaltrials.gov): NCT02436707
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: May 05, 2015



    On Hold
    AL5 (DFCI 06-254)Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial
    Al.5 is the follow-on study to the phase II trial, AL.4. In this study, previously untreated patients with newly diagnosed ALL are treated with the successful pediatric ALL regimen, using PEG (polyethylene glycosylated E.coli) - asparaginase. PEG-asparaginase will hopefully increase the proportion of adult patients that are able to tolerate the full duration of asparaginase therapy. Patients who are Philadelphia chromosome positive will also receive Gleevec.
    Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial

    Complexity Level: 1

    Eligibility: Eligibility: All adults aged 18 to 50 years with newly diagnosed ALL will be eligible for this protocol. Patients with ALL-L3 will not be eligible for this study.

    Objectives: Primary: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. The primary endpoint of this study is the feasibility of the intensification therapy, measured as the percentage of patients who, having achieved a CR after induction therapy, receive more than 25 weeks of IV PEG asparaginase as part of intensification therapy. To explore the relative toxicity of IV PEG asparaginase. To explore the relative efficacy and toxicity of adding imatinib to multiagent chemotherapy for patients with Philadelphia-positive ALL.

    NCT Registration ID (from clinicaltrials.gov): NCT01005758
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 10, 2008 Closing Date: January 08, 2013



    Closed to Accrual
    ALC2 (CALGB C10603)A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PK412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML).
    The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. In this study, patients will receive either the experimental agent, midostaurin, combined with daunorubicin and cytarabine or placebo, also known as a ?sugar pill,? combined with daunorubicin and cytarabine. This research is being done because we do not know whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone.
    A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PK412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML).

    Complexity Level: 1

    Eligibility: Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification, excluding M3 (acute promyelocytic leukemia); Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol-designated FLT3 screening laboratory; Age 18 and < 60 years; No prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis; emergency treatment for hyperleukocytosis with hydroxyurea for 5 days; cranial RT for CNS leukostasis (one dose only); growth factor/cytokine support. AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic (including azacitidine or decitabine) therapy for MDS; Patients who have developed therapy related AML after prior RT or chemotherapy for another disorder or cancer are not eligible; Patients with symptomatic congestive heart failure are not eligible; Bili < 2.5 UNL; Non-pregnant and non-nursing.

    Objectives: Overall Survival Complete response rate in remission induction, event-free survival, disease-free survival and the DRS rate one year after completing maintenance

    NCT Registration ID (from clinicaltrials.gov): NCT00651261
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 21, 2009 Closing Date: October 14, 2011



    Closed to Accrual
    CLC2 (ALLIANCE A041202)A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (> = to 65 years of age) with Chronic Lymphocytic Leukemia (CLL).

    A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (> = to 65 years of age) with Chronic Lymphocytic Leukemia (CLL).

    Complexity Level: 2

    Eligibility: Intermediate or high-risk Rai stage chronic lymphocytic leukemia. Patients must be age 65 or older and have not received previous treatment for CLL.

    Objectives: To determine whether progression free survival (PFS) is superior after therapy with bendamustine in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated CLL

    NCT Registration ID (from clinicaltrials.gov): NCT01886872
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 05, 2015 Closing Date: May 01, 2016



    Closed to Accrual
    HD8 (EORTC 20012)BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma
    The purpose of this study is to compare the effects on the patient and their Hodgkins disease between treatment with BEACOPP compared to standard treatment with ABVD. This research is being done because currently it is not known which of these two treatments is better. Treatment with BEACOPP has been used in previous studies and seems promising, however it is not clear if it can offer better results than standard treatment with ABVD.
    BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma

    Complexity Level: 2

    Eligibility: Patients with histologically documented Hodgkin's lymphoma/disease, except for the subtype lymphocyte predominant, nodular type (nodular paragranuloma). Patients must be clinical stage III or IV and have at least one bi-dimensionally measurable target lesion. Patients with extranodal disease only will be eligible if they have at least one bi-dimensionally measurable extranodal lesion.

    Objectives: The primary end point is Event-Free-Survival (EFS), also called Time to Treatment Failure or Freedom From Treatment Failure (FFTF). For this end-point, an "event" is defined as early discontinuation of protocol treatment, absence of CR after 8 cycles, relapse, progression or death. The secondary endpoints are: complete response (CR), disease free survival (DFS) in CR patients, overall survival (OS), quality of life (QoL), occurrence of second malignancies and cost effectiveness.

    NCT Registration ID (from clinicaltrials.gov): NCT00049595
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: May 13, 2003 Closing Date: January 08, 2010



    Closed to Accrual
    CL3 (CALGB C10404)A Genetic, Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients with Symptomatic Previously Untreated Chronic Lymphocytic Leukemia
    The purpose of this study is to find out what effects treatment with one of three different therapies that include combinations of the drugs fludarabine, rituximab, cyclophosphamide, and lenalidomide have on the patient and the CLL.
    A Genetic, Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients with Symptomatic Previously Untreated Chronic Lymphocytic Leukemia

    Complexity Level: 2

    Eligibility: B-cell chronic lymphocytic leukemia (CLL); Creatinine less than or equal to 1.5 x ULN; Lymphocytosis > 5,000/uL with less than 55% prolymphocytes; Bone marrow aspirate with > 30% of all nucleated cells being lymphoid or bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; Overall cellularity must be normocellular or hypercellular; Monoclonal B-cell population that is positive for >/= 1 B-lineage markers (CD19, CD20, CD23) with co-expression of CD5 (bright surface immunoglobulin patients must co-express CD23): Symptomatic and active intermediate risk (lymphadenopathy and/or hepatosplenomegaly) or high risk (Hgb less than 11 g/dL or platelets less than 100,000/uL) category of modified Rai staging system; No prior therapy for CLL; No medical condition requiring chronic use of oral corticosteroids; Age >/= 18 years; Performance Status 0 - 2; HIV patients may be eligible if the criteria are met; Non-pregnant and non-nursing

    Objectives: Progression free survival

    NCT Registration ID (from clinicaltrials.gov): NCT00602459
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 13, 2009 Closing Date: August 17, 2012



    Closed to Accrual
    MYX1 (MCRN-003)A Single Arm Phase II Study of High-Dose Weekly Carfilzomib plus Cyclophosphamide and Dexamethasone in the Treatment of Relapsed Multiple Myeloma After 1-3 Prior Therapies
    The purpose of this study is to find out what effects carfilzomib has on multiple myeloma when given in combination with cyclophosphamide and dexamethasone.
    A Single Arm Phase II Study of High-Dose Weekly Carfilzomib plus Cyclophosphamide and Dexamethasone in the Treatment of Relapsed Multiple Myeloma After 1-3 Prior Therapies

    Complexity Level: 2

    Eligibility: Enrolled patients must meet standard diagnostic criteria for multiple myeloma. They must have relapsed disease according to the International Myeloma Working group criteria. Prior autologous stem cell transplant is allowed but not required. This study will be restricted to patients who have had at least one, but not more than three, prior lines of therapy.

    Objectives: The primary objective of the Phase II portion of the study is to determine the overall response rate of this novel drug combination. The secondary objectives are: 1. To determine the safety and toxicity profile of the combination 2. To determine the progression-free survival 3. To determine the 2-year overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT02597062
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: March 29, 2016 Closing Date: January 25, 2018



    Closed to Accrual
    MDC1 (SWOG S1117)A Randomized Phase II/III Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

    A Randomized Phase II/III Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

    Complexity Level: 2

    Eligibility: Patients must have morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).

    Objectives: Primary: Response Rate Secondary: Relapse-free Survival; Overall Survival; Cytogenetic Response Rate; Frequency and Severity of Toxicities; Predictors of Response; Optional Tumour Banking

    NCT Registration ID (from clinicaltrials.gov): NCT01522976
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: November 22, 2012 Closing Date: November 15, 2014



    Closed to Accrual
    LYC1 (ECOG E1411)Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -> R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -> R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB -> LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV -> LR)
    The purpose of this study is to compare the effects of the drugs bortezomib and lenalidomide, compared to other drugs used to treat mantle cell lymphoma in patients over the age of 18.
    Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -> R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -> R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB -> LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV -> LR)

    Complexity Level: 2

    Eligibility: Patients must have confirmed diagnosis of mantle cell lymphoma and must be greater than 18 years old.

    Objectives: Primary: progression free survival in induction and consolidation Secondary: PET document complete response rate, objective response rate, overall survival, safety

    NCT Registration ID (from clinicaltrials.gov): NCT01415752
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 12, 2014 Closing Date: September 09, 2016



    Closed to Accrual
    LY16 (LYSARC RELEVANCE)A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma
    The purpose of this study is to compare the effects on follicular lymphoma of a new drug lenalidomide in combination with rituximab compared to other drug regimens used to treat this disease. This research is being done because the combination of lenalidomide with rituximab in patients with follicular lymphoma has been studied in a few people and seems promising but it is not clear if it can offer better results than the treatments used in the control arm. The standard or usual treatment for this disease is treatment with chemotherapy and rituximab.
    A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma

    Complexity Level: 2

    Eligibility: Investigator-assessed diagnosis of Stage II-IV CD20+ follicular lymphoma (grade 1-3a)

    Objectives: Co-Primary: complete response (CR/CRu), progression free survival (PFS) Secondary: event free survival (EFS),time to next anti-lymphoma treatment (TTNLT, overall survival (OS), safety, Exploratory: CR rate at 120 weeks and PFS, time to treatment failure (TTF), time to next chemotherapy treatment (TTNCT) and overall response rate (ORR) at 120 weeks, biomarker analysis, health related QoL and health economics.

    NCT Registration ID (from clinicaltrials.gov): NCT01650701
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: June 17, 2013 Closing Date: November 10, 2014



    Closed to Accrual
    LY12A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation.
    Chemotherapy that is given for non-Hodgkin's lymphoma when it has come back after previous treatment is called "salvage" chemotherapy. Depending on how well the lymphoma responds to salvage chemotherapy, a stem cell harvest and transplant might be done afterward. This research is being done because even when lymphoma goes away or gets better with salvage chemotherapy and stem cell harvest, it is important to find ways to keep it from coming back or getting worse after those treatments are completed. Rituximab has not been approved for this specific use by Health Canada or the U.S. Food and Drug Administration.
    A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation.

    Complexity Level: 2

    Eligibility: Patients to be included are those with a diagnosis of aggressive histology (B cell or T cell) non-Hodgkin's lymphoma whose disease is refractory to or relapsed after one prior first-line, anthracycline-containing chemotherapy regimen. Patients with CD20+ve B cell disease will be further evaluated after completion of protocol salvage treatment and autologous stem cell transplant (ASCT) for randomization to either maintenance rituximab or observation alone.

    Objectives: Randomization 1, Salvage Treatment [(R)-GDP vs (R)DHAP]. Primary: to compare response rates between the two salvage groups after two cycles of either (R)-GDP or (R)-DHAP; to compare the transplntation rate of the two salvage regimens. Secondary: to compare between the two arms event-free survival and overall survival, successful mobilization rates, quality of life, toxic effects, resource utilization, and medical/societal costs. Randomization 2, Maintenance (rituximab vs observation). Primary: to compare two-year event-free survival between the two maintenance groups. Secondary: to compare between the two arms two-year overall survival and toxic effects.

    NCT Registration ID (from clinicaltrials.gov): NCT00078949
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: August 07, 2003 Closing Date: December 31, 2012



    Closed to Accrual
    CLC2EA Prospective Economic Analysis of NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia
    There is a cost burden associated with the diagnosis and treatment of CLL. Newer chemotherapy and targeted agents may increase these costs further. Ongoing evaluation of cost in relation to benefit of these new therapies is important. Collecting cost and utilization data alongside a clinical trial can yield high quality outcome and cost data, providing a robust estimate of cost effectiveness of the intervention studied. Primary goal of this study is to determine the cost-effectiveness of ibrutinib-containing regimens compared to bendamustine-rituximab
    A Prospective Economic Analysis of NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia

    Complexity Level: 3

    Eligibility: All Canadian patients registered to CLC.2

    Objectives: To determine the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab.

    NCT Registration ID (from clinicaltrials.gov): NCT02414022
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: March 13, 2015 Closing Date: May 01, 2016



    Closed to Accrual
    ALC3 (SWOG S1203)A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
    The purpose of this study is to compare the effects of a new drug, vorinostat, compared to other drugs which are commonly-used drugs to treat acute myeloid leukemia and to find stem cell transplant donors for patients who might benefit from a stem cell transplant according to standard practice.
    A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

    Complexity Level: 1

    Eligibility: Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML).

    Objectives: Primary:event-free survival; feasibility of completing an allogeneic hematopoietic cell transplantation in 60% or more of patients in frist complete remission.

    NCT Registration ID (from clinicaltrials.gov): NCT01802333
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 10, 2013 Closing Date: November 04, 2015



    Closed to Accrual
    ALC1 (S0106)A Phase III Study Of The Addition Of Mylotarg? During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg? Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia
    The purpose of this study is to compare the effects myeloid leukemia (AML) cancer of a new drug gemtuzumab ozogamicin (Mylotarg ) compared to other drugs which are commonly-used drugs to treat this disease, in patients under the age of 56.
    A Phase III Study Of The Addition Of Mylotarg? During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg? Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia

    Complexity Level: 1

    Eligibility: Patients must have a morphologically confirmed diagnosis of acute myeloid leukemia (AML) with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration.

    Objectives: -Compare DFS of patients under age 56 with previously untreated, de novo, non-M3, AML who receive Mylotarg as post-consolidation therapy versus patients who receive no post-consolidation therapy. -Compare CR rate achieved by the addition of Mylotarg to standard induction chemotherapy in patients under the age of 56 with previously untreated, de novo, non-M3 AML. The durability of complete response will also be measured. -Estimate the frequency and severity of toxicities of the addition of Mylotarg to induction therapy and post-consolidation therapy. -To evaluate the prognostic significance of CD33 expression on the response rate of patients who receive Mylotarg. -To evaluate the prognostic significance of FLT3 mutations and flow through cytometic detection prior to therapy, and of minimal residual disease in remission specimens collected before and after consolidation therapy and after post-consolidation therapy with Mylotarg.

    NCT Registration ID (from clinicaltrials.gov): NCT00085709
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 27, 2006 Closing Date: August 20, 2009



    Permanently Closed
    LY13A Multi-centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone and Rituximab (BCVP-R) for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment
    The purpose of this study is to find out what effects the drug bortezomib, when given in combination with cyclophosphamide, vincristine, prednisone, and rituximab (CVP-R), has on you and your follicular lymphoma.
    A Multi-centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone and Rituximab (BCVP-R) for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment

    Eligibility: Patients with histologically confirmed, advanced stage (III or IV) follicular lymphoma requiring systemic first-line treatment will be eligible.

    Objectives: Primary: To assess the efficacy (complete response rate, CR/CRu) of BCVP-R as treatment for patients with advanced stage follicular non-Hodgkin's lymphoma requiring systemic first-line treatment; to assess the incidence of severe neurotoxicity (defined as grade 3 or 4 neuropathy/ neuropathic pain during the first four cycles) of the BCVP-R regimen in this group of patients. Secondary: To assess overall response rate in patients treated with the combination of BCVP-R, and to determine the response duration; to determine progression-free and overall survival in this patient group; to evaluate the tolerability and characterize the toxicity profile of the BCVP-R regimen in this patient population; to assess quality of life with particular focus on neurotoxicity-related changes in this patient population treated with BCVP-R. Correlative Studies. Apoptocic molecule expression, the role of the microenvironment, and Fc receptor polymorphisms.

    NCT Registration ID (from clinicaltrials.gov): NCT00428142
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 2006 Closing Date: March 06, 2009



    Permanently Closed
    LY4Phase I/II Study of Chemotherapy Intensification for Patients With Poor Prognosis Advanced Stage Aggressive histology Lymphoma: VACOP-B Plus Etoposide and Cyclophosphamide With RhuGM-CSF (VACOP-B/EC/CSF)

    Phase I/II Study of Chemotherapy Intensification for Patients With Poor Prognosis Advanced Stage Aggressive histology Lymphoma: VACOP-B Plus Etoposide and Cyclophosphamide With RhuGM-CSF (VACOP-B/EC/CSF)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1992 Closing Date: October 25, 1994



    Permanently Closed
    HD6A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease
    A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy Versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease. The purpose of this study is to determine which of the treatments is more effective in 1) prolonging my life and 2) reducing premature death from long term side effects of the treatment.
    A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease

    Eligibility: Patients with clinical stage I or IIA previously untreated Hodgkin's disease, excluding patients with very favourable or very unfavourable (bulky mediastinum) prognosis.

    Objectives: To compare 12 year survival between groups, to assess freedom from progression at 5 and 10 years, and to assess secondary endpoints: proportion of complete remission, proportion free from 2nd disease progression at 5 and 10 years, cause specific survival, toxicity, and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00002561
    Participation: Limited to centres with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 25, 1994 Closing Date: April 05, 2002



    Permanently Closed
    MY8 (E1A95)A Phase III Study Of PSC-833 In Combination With Vincristine, Doxorubicin And Dexamethasone (PSC-833/VAD) vs VAD Alone In Patients With Relapsing Or Refractory Mutilple Myeloma

    A Phase III Study Of PSC-833 In Combination With Vincristine, Doxorubicin And Dexamethasone (PSC-833/VAD) vs VAD Alone In Patients With Relapsing Or Refractory Mutilple Myeloma

    NCT Registration ID (from clinicaltrials.gov): NCT00002878
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1997 Closing Date: May 10, 2000



    Permanently Closed
    LY7 (EORTC 20981)Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma: A Phase III Randomized Clinical Trial
    The purpose of this study is to see if the drug Rituxan given with standard chemotherapy is better than standard chemotherapy alone in shrinking lymphoma as well, in patients who have responded to the first part of treatment to see if Rituxan is better than no further treatment in preventing the lymphoma from getting worse or coming back.
    Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma: A Phase III Randomized Clinical Trial

    Complexity Level: 2

    Eligibility: Patients with stage III or IV follicular non-Hodgkin's lymphoma (at initial diagnosis) who have relapsed after a maximum of two non-anthracycline containing systemic chemotherapy regimens. Patients must have had a complete or partial response to at least one of the previous regimens. Lymphoma must be CD20 positive.

    Objectives: To establish the effect of addition of rituximab to CHOP chemotherapy on the response rate and quality of remission in relapsed low grade non-Hodgkin's lymphoma. To establish the effect of maintenance treatment with rituximab on progression free survival in relapsed low grade non-Hodgkin's lymphoma in remission after CHOP ? rituximab.

    NCT Registration ID (from clinicaltrials.gov): NCT00004179
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 15, 2000 Closing Date: February 06, 2004



    Permanently Closed
    LY1A Trial of BCG in Non-Hogkin's Lymphoma

    A Trial of BCG in Non-Hogkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 07, 1976 Closing Date: May 01, 1981



    Permanently Closed
    MY1A Comparison of the Administration of Melphalan, Cyclophosphamide and BCNU in Sequential Alternating and Concurrent Schedules in the Treatment of Plasma Cell Myeloma

    A Comparison of the Administration of Melphalan, Cyclophosphamide and BCNU in Sequential Alternating and Concurrent Schedules in the Treatment of Plasma Cell Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1973 Closing Date: March 01, 1977



    Permanently Closed
    CL2A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia
    Chronic lymphocytic leukemia (CLL) is often treated with a kind of chemotherapy drug called fludarabine, which is given intravenously. Recently, this drug has become available in a pill form (taken by mouth).The purpose of this study is to find out what effects giving oral fludarabine this cancer.
    A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia

    Eligibility: Patients with previously untreated B-cell chronic lymphocytic leukemia, requiring treatment. Submission of blood samples for immunophenotyping, FISH and PCR studies are a requirement for participation.

    Objectives: To determine overall (CR, PR) response rate. Secondary endpoints include assessment of molecular CR rate, toxicity, progression-free and treatment-free survival as well as determination of the incidence of defined genetic abnormalities in the study population. The prognostic and predictive significance of genetic abnormalities and immunophenotypic profile at the start of treatment, with respect to response to oral fludarabine, will be evaluated.

    NCT Registration ID (from clinicaltrials.gov): NCT00049075
    Participation: Limited to centres expecting to accrue > 4 patients/year
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 08, 2002 Closing Date: January 30, 2004



    Permanently Closed
    HD5 (8952)Treatment of Advanced Hodgkin's Disease a Randomized Phase III Trial Comparing ABVD versus MOPP/ABV Hybrid

    Treatment of Advanced Hodgkin's Disease a Randomized Phase III Trial Comparing ABVD versus MOPP/ABV Hybrid

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 01, 1993 Closing Date: November 10, 1995



    Permanently Closed
    AL4 (DFCI 01-175)A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol
    The primary purpose of this study is to determine the safety and best dosing of a chemotherapy drug called L-asparaginase in patients with ALL. L-aspariginase has been used for this purpose in varying doses for childhood ALL. This research is being done because we do not know what is the best and safest dose for patients with ALL to receive, and we also hope to gain more information about your disease.
    A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol

    Complexity Level: 1

    Eligibility: Patients must have pathologically documented de novo acute lymphoblastc leukemia, excluding mature B-cell ALL, which is diagnosed by the presence of either surface immunoglogulin, L3 morphology or one of the following cytogentic abnormalities t(8;14)(q24;q32), t(8;22), or t(2;8).

    Objectives: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. To determine the safety and optimal dosing of L-asparaginase during the intensification period. To determine the pharmacokinetics of weekly E.coli L-asparaginase by evaluating serum asparaginase levels in all patients To determine the toxicity of individualized dosing of E.coli L-asparaginase based upon asparaginase levels To determine the prognostic significance of early response to induction chemotherapy within the context of our treatment program To evaluate the outcome of patients based upon bone marrow status after 15 days of multi-agent induction chemotherapy, comparing the outcome of patients with M3 status (>25% leukemia cells still present) at that time point versus those with M1/M2 status (<25% leukemia cells still present) or hypoplastic marrows. To evaluate the outcome of patients base

    NCT Registration ID (from clinicaltrials.gov): NCT00136435
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 24, 2005 Closing Date: February 21, 2008



    Permanently Closed
    HD4A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease

    A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 1984 Closing Date: December 29, 1989



    Permanently Closed
    HD2Comparison of Radiotherapy Alone With Radiotherapy Preceded by or Preceded and Followed by Three Courses of MOPP, With Standardized Treatment of First and Second Relapse and Incomplete Remission

    Comparison of Radiotherapy Alone With Radiotherapy Preceded by or Preceded and Followed by Three Courses of MOPP, With Standardized Treatment of First and Second Relapse and Incomplete Remission

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 14, 1977 Closing Date: June 11, 1979



    Permanently Closed
    LY3A Comparison of Standard BACOP With Escalated BACOP in Patients With Poor Prognosis Non-Hodgkin's Lymphoma

    A Comparison of Standard BACOP With Escalated BACOP in Patients With Poor Prognosis Non-Hodgkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 10, 1982 Closing Date: April 19, 1989



    Permanently Closed
    MY7A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients

    A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients

    Eligibility: Patient with newly diagnosed, histologically proven, untreated, symptomatic Stage I or Stage II or III myeloma, with either a measurable serum M-protein or Bence Jones M-protein of >1.0g/24h and an ECOG performance status of <4.

    Objectives: To Compare overall survival between patients receiving M+P versus M+D as induction therapy and patients maintained by dexamethasone versus observation. To compare time progression, response rates, incidences of toxicities and quality of life with the same groups of patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00002678
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 02, 1995 Closing Date: July 16, 2003



    Permanently Closed
    CLC1 (CALGB C10501)A Phase III Intergroup CLL Study of Asymptomatic, Untreated Chronic Lymphocytic Leukemia Patients Randomized to Early Intervention versus Observation in the High Risk Genetic Subset with IG VH Un-mutated Disease
    In this study, previously untreated patients with CLL who are asymptomatic are assessed for high risk by a central laboratory which undertakes immunoglobulin heavy chain rearrangement studies. Patients who are low risk are followed until they become symptomatic, at which time they are treated with fludarabine and rituxan. Patients who are high risk are randomized to either the same strategy of watchful waiting until they become symptomatic or they are randomized to early treatment with fludarabine and rituxan.
    A Phase III Intergroup CLL Study of Asymptomatic, Untreated Chronic Lymphocytic Leukemia Patients Randomized to Early Intervention versus Observation in the High Risk Genetic Subset with IG VH Un-mutated Disease

    Complexity Level: 2

    Eligibility: Patients must be within 6 motnhs of the initial flow cytometric confirmation of b-cell chronic lymphocytic leukemia (CLL). This interval begins with the intial flow cytometric conformation of disease. Clinical and immunophenotypic documentation of CLL including: - Lymphocytosis >5000 uL with <55% prolymphocytes - Monoclonal B-cell population is positive for > 1 B-lineage marker (CD19, CD20, CD23) with co-expression of CD5. Patients with bright surface immunoglobulin levels must have CD23 co-expression and absence of t(11:14)on interphase sytogenetics or have negative tumor protein staining for cyclin D1. Asymptomatic low risk category of modified Rai staging system (Rai stage 0-1). No prior therapy for CLL including corticosteroids; Age > 18yrs; Performance status 0-1; No HIV disease; Non-pregnant and non-nursing.

    Objectives: To determine if early treatment with chemoimmunotherapy extends the time to second treatment (TT2T), and overall survival in genetically high-risk (un-mutated Ig VH), newly diagnosed, asymptomatic CLL patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00513747
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 18, 2008 Closing Date: December 24, 2009



    Permanently Closed
    HD7 (ECOG E2496)A Randomized Phase III Trial of ABVD Versus Stanford V with or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease
    The purpose of this study is to compare the effects (good and bad) on the patient and their Hodgkin's disease of a standard combination of drugs called ABVD to a combination of drugs and radiation called the Stanford V.
    A Randomized Phase III Trial of ABVD Versus Stanford V with or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease

    Complexity Level: 2

    Eligibility: Previously untreated patients with histologically proven Hodgkin's disease (HD). The diagnosis should be made by excisional biopsy whenever possible, but fine needle aspirate may suffice if 1) the morphology is unequivocal and 2) immunohistochemical studies are consistent with the diagnosis of HD. ECOG performance status must be 0 - 2.

    Objectives: To compare the failure-free survival in patients with locally extensive and advanced stage Hodgkin's disease treated with standard ABVD chemotherapy versus patients given Stanford V chemotherapy with or without radiotherapy. To assess overall survival and freedom from progression in these patients at 5 and 10 years. To assess secondary endpoints: pulmonary function, incidence of second cancers, reproductive function (baseline and 5 years) and deaths from causes other than Hodgkin's disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00003389
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 07, 2000 Closing Date: June 15, 2006



    Permanently Closed
    HD3Protocol For a Second Cooperative Clinical Trial for the Treatment of Patients With Stages IVB and IV Hodgkin's Disease Using Chemotherapy and Irradiation Therapy

    Protocol For a Second Cooperative Clinical Trial for the Treatment of Patients With Stages IVB and IV Hodgkin's Disease Using Chemotherapy and Irradiation Therapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1977 Closing Date: May 01, 1980



    Permanently Closed
    MY6Clinical Trial of Interferon versus no Additional Treatment in Multiple Myeloma Patients Who Have Responded to Melphalan and Prednisone

    Clinical Trial of Interferon versus no Additional Treatment in Multiple Myeloma Patients Who Have Responded to Melphalan and Prednisone

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 04, 1987 Closing Date: June 26, 1992



    Permanently Closed
    MY4Etidronate Disodium (EHDP) Versus Placebo in the Treatment of Multiple Myeloma

    Etidronate Disodium (EHDP) Versus Placebo in the Treatment of Multiple Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 19, 1983 Closing Date: February 28, 1987



    Permanently Closed
    LY11 (S9704)A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups
    The purpose of this study is to compare the effects (good and bad) on this lymphoma of a combination of treatments (induction chemotherapy, followed by high-dose chemotherapy with or without radiation, followed by stem cell infusion) to the standard treatment. The combination of treatments (chemotherapy followed by high-dose chemotherapy and stem cell infusion) has not been used to treat a large number of patients with this kind of cancer.
    A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups

    Complexity Level: 1

    Eligibility: Patients must have biopsy proven intermediate or high grade non-Hodgkin's lymphoma (Working Formulation groups D through H and J) except lymphoblastic lymphoma (Working Formulation group I). Transformed lymphomas are not eligible. Mantle cell lymphomas are considered to be Working Formulation group E, but are ineligible for this study.

    Objectives: To compare in a cooperative group setting the overall survival and progression free survival of patients in the age adjusted High-Intermediate and High Risk Prognostic Groups of the International Classification with diffuse aggressive non-Hodgkin?s lymphomas who are treated on a randomized trial that compares standard conventional chemotherapy to an abbreviated course of induction chemotherapy followed by early transplantation. To compare the toxicity of these treatment strategies.

    NCT Registration ID (from clinicaltrials.gov): NCT00004031
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 28, 2001 Closing Date: December 15, 2007



    Permanently Closed
    MY2Continuing versus Stopping Therapy in Patients Stabilized on Melphalan and Prednisone

    Continuing versus Stopping Therapy in Patients Stabilized on Melphalan and Prednisone

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 23, 1977 Closing Date: December 14, 1984



    Permanently Closed
    HD1Protocol For a Cooperative Clinical Trial Comparing MOPP Alone versus MOPP Followed by Radiation in Stage IIIB and IV Hodgkin's Disease

    Protocol For a Cooperative Clinical Trial Comparing MOPP Alone versus MOPP Followed by Radiation in Stage IIIB and IV Hodgkin's Disease

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1971 Closing Date: September 01, 1976



    Permanently Closed
    LY2Treatment of Poor Prognosis Lymphomas With Bone Marrow Involvement, Intensive BACOP Chemotherapy Under Cover of Septra Prophylaxis

    Treatment of Poor Prognosis Lymphomas With Bone Marrow Involvement, Intensive BACOP Chemotherapy Under Cover of Septra Prophylaxis

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 01, 1980 Closing Date: December 01, 1980



    Permanently Closed
    AL3 (CALGB C9710)Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia
    The purposes of this study are to attempt to: 1) eliminate the leukemia cells responsible for this disease (that is, achieve a remission or the disappearance of leukemia); 2) gain information about this disease; and 3) evaluate the usefulness and side effects of the treatment.
    Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia

    Complexity Level: 1

    Eligibility: Diagnosis of acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by RT-PCR assay. Prior treatment: No systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient. Non-pregnant, non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Patients should not become pregnant or plan to become pregnant while on treatment.

    Objectives: To compare the efficacy (event-free survival) and toxicities of two induction/consolidation therapies for patients with untreated APL: ATRA/ara-C/daunorubicin with or without arsenic trioxide (AS2O3). To evaluate the efficacy (disease-free survival) and toxicities of maintenance therapy with intermittent ATRA versus intermittent ATRA plus 6-MP/MTX for patients with APL who achieve a complete response.

    NCT Registration ID (from clinicaltrials.gov): NCT00003934
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 18, 2002 Closing Date: March 29, 2005



    Permanently Closed
    AL1Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia

    Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 07, 1981 Closing Date: June 08, 1982



    Permanently Closed
    MY9Randomized Phase II Dose Finding Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

    Randomized Phase II Dose Finding Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

    NCT Registration ID (from clinicaltrials.gov): NCT00006890
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 12, 2000 Closing Date: September 07, 2001



    Permanently Closed
    HL1 (8691)A Randomized Comparison of Deoxycoformycin versus Alpha Interferon in Previously Untreated Patients With Hairy Cell Leukemia

    A Randomized Comparison of Deoxycoformycin versus Alpha Interferon in Previously Untreated Patients With Hairy Cell Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 05, 1987 Closing Date: October 01, 1991



    Permanently Closed
    AL2 (INT 0129)Phase III Randomized Study of All-Trans Retinoic Acid versus Cytosine Arabinoside and Daunorubicin as Inductive Therapy for Patients with Previously Untreated Acute Promyelocytic Leukemia

    Phase III Randomized Study of All-Trans Retinoic Acid versus Cytosine Arabinoside and Daunorubicin as Inductive Therapy for Patients with Previously Untreated Acute Promyelocytic Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1992 Closing Date: February 01, 1995



    Permanently Closed
    MY3Pilot Study of Weekly Cyclophosphamide and Prednisone Therapy for Patients Unresponsive to Melphalan and Prednisone Induction Therapy

    Pilot Study of Weekly Cyclophosphamide and Prednisone Therapy for Patients Unresponsive to Melphalan and Prednisone Induction Therapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 01, 1982 Closing Date: September 01, 1984



    Permanently Closed
    MY5Modified VAD (m-VAD-VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE) in Primary Refractory and Relapsed Plasma Cell Myeloma

    Modified VAD (m-VAD-VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE) in Primary Refractory and Relapsed Plasma Cell Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 28, 1986 Closing Date: October 17, 1989



    Permanently Closed
    MY11A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma
    This study is to find out what effects the combination of lenalidomide and melphalan has on patients and their myeloma. Two different doses of lenalidomide will be studied to see which dose can be safely given and what sort of treatment response is achieved when lenalidomide is used with melphalan. All patients who complete all of the planned courses of lenalidomide and melphalan will then continue to receive dexamethasone as long as the side effects are not too severe and the disease does not come back.
    A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma

    Eligibility: Previously untreated patients with histologically confirmed myeloma who are not considered candidates for future peripheral blood stem cell autotransplantation by virtue of advanced age, co-morbid illness or patient preference.

    Objectives: Primary: 1) To evaluate the tolerability of combination therapy with lenalidomide and melphalan in patients with previously untreated multiple myeloma not destined for future autologous stem cell transplant. Two starting doses of lenalidomide (15mg or 10mg days 1-21 each 28 day cycle) will be investigated. 2) To determine an estimate of the efficacy of the combination of melphalan and lenalidomide. The primary measure of efficacy will be the percentage of patients who, after completing six cycles of therapy, achieve a complete remission using European Group for Blood and Marrow Transplantation/International Bone marrow transplant registry criteria for remission assessment.

    NCT Registration ID (from clinicaltrials.gov): NCT00305812
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 13, 2005 Closing Date: March 27, 2008



    Permanently Closed
    MY10 (MY10)A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma
    This research is being done because researchers believe that a combination of prednisone and thalidomide, given after autologous stem cell transplant, may slow down the return of myeloma. Nevertheless, because both thalidomide and prednisone have potentially serious side effects and might diminish quality of life, it is very important to determine whether or not these drugs are any better than no further treatment. Further, if they are better, are the side effects too great a price to pay?
    A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed myeloma who had had an autologous stem cell transplant within one year of the beginning of initial treatment for their disease. Patients must be randomized within 60-100 days post transplant and have no other medical condition precluding long term use of prednisone or thalidomide.

    Objectives: Primary: to determine if maintenance treatment post transplant with thalidomide and prednisone (TP) prolongs overall survival compared with observation alone. Secondary: to determine if TP prolongs progression-free survival compared with observation alone; to compare quality of life, toxic effects, and the incidence of venous thromboembolism between the two patient groups. Correlative Studies Endpoints: to correlate FISH-identified chromosome translocations at relapse with clinical outcome in the two patient groups; to determine if there is evidence of increased thrombin generation in patients receiving TP as compared with those not.

    NCT Registration ID (from clinicaltrials.gov): NCT00049673
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 16, 2002 Closing Date: January 30, 2009



    Permanently Closed
    LY9 (M39045)Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8)
    The purpose of this study is to evaluate the effects (good and bad) of a new drug Rituxan in combination with other drugs which are commonly-used to treat your type of non-Hodgkin's lymphoma. The experimental drug, Rituxan is a new immunological medicine that is added to commonly used drugs to try to make the treatment more effective.
    Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8)

    Complexity Level: 2

    Eligibility: Patients aged 18 to 60 years with untreated CD20-positive diffuse large B-cell non-Hodgkin's lymphoma. Patients must have stage II to IV or stage I with bulky disease according to Ann Arbor staging.

    Objectives: To determine the safety and efficacy of rituximab antibody in patients with diffuse large B-cell non-Hodgkin's lymphoma in combination with a standard CHOP-like chemotherapy regimen. The primary endpoint of this trial is the time to treatment failure.

    NCT Registration ID (from clinicaltrials.gov): NCT00064116
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 08, 2001 Closing Date: October 17, 2003



    Permanently Closed
    LY8A Phase III Study of Involved Field Radiation Therapy (IFRT) in Patients With Histologically Aggressive Non-Hodgkin's Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT)
    The purpose of this study is to compare the effects of involved field radiation therapy vs. observation (ie. no treatment) in patients with aggressive non-Hodgkin's lymphoma. We do not currently know which of these two commonly used methods is better.
    A Phase III Study of Involved Field Radiation Therapy (IFRT) in Patients With Histologically Aggressive Non-Hodgkin's Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT)

    Eligibility: Patients with relapsed or refractory histologically aggressive non-Hodgkin?s lymphomas, who showed chemotherapy sensitivity will undergo high-dose therapy and autologous bone marrow/blood stem cell transplantation. Patients with bulky disease (> 5 cm) before initiation of salvage chemotherapy, and those with non-bulky disease not achieving a complete response to salvage chemotherapy are eligible.

    Objectives: To compare overall survival, 3-year progression free survival (within and outside of radiation fields), QOL and toxicities between patients treated with IFRT and those observed.

    NCT Registration ID (from clinicaltrials.gov): NCT0031668
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 31, 2001 Closing Date: November 11, 2002



    Permanently Closed
    LY15A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma.
    The purpose of this study is to find the highest dose of romidepsin that can safely be given in combination with gemcitabine, dexamethasone, and cisplatin (GDP) without causing very severe side effects that are not tolerable. This is done by starting at a dose lower than the one that does not cause side effects in animals. Patients are given romidepsin and GDP and watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of romidepsin (with GDP). Patients joining the study later on will get higher doses of romidepsin (with GDP) than patients who join earlier. This will continue until a dose is found that causes severe but temporary side effects.
    A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma.

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have histologically confirmed peripheral T cell lymphoma (PTCL) or diffuse large B cell lymphoma, and must have received one or two previous treatment regimens (histologic proof of disease by biopsy is mandatory). There must be clinically or radiologically measurable disease at baseline.

    Objectives: - To evaluate the safety and feasibility of the combination of gemcitabine, dexamethasone and cisplatin (GDP) and romidepsin in relapsed/refractory aggressive lymphomas (including PTCL and DLBCL). - To identify the maximum tolerated doses of romidepsin, gemcitabine, dexamethasone and cisplatin used in combination. - To evaluate preliminary evidence of anti-tumour activity. - To establish a recommended phase II dose of romidepsin to be given in combination with GDP in a planned randomized phase II trial in newly diagnosed untreated PTCL.

    NCT Registration ID (from clinicaltrials.gov): NCT01846390
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 30, 2013 Closing Date: April 26, 2016



    Permanently Closed
    LY10A Phase II Study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) in Patients With Either Hodgkin's Disease or Aggressive Histology Non-Hodgkin's Lymphoma Which is Relapsed or Refractory

    A Phase II Study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) in Patients With Either Hodgkin's Disease or Aggressive Histology Non-Hodgkin's Lymphoma Which is Relapsed or Refractory

    Eligibility: Patients with a diagnosis of either Hodgkin's disease or aggressive histology non-Hodgkin's lymphoma of B-cell origin, whose disease is refractory to or relapsed after one prior chemotherapy regimen.

    Objectives: To determine the efficacy (response rates and percent of complete remissions) following two cycles of treatment with GDP for patients with relapsed or refractory Hodgkin's disease and for patients with relapsed or refractory aggressive histology non-Hodgkin's lymphoma

    NCT Registration ID (from clinicaltrials.gov): NCT00014209
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 12, 2000 Closing Date: July 12, 2002



    Permanently Closed
    CM1 (SWOG S0325)A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.
    The standard treatment for chronic myelogenous leukemia (CML) is to provide therapy with an anticancer drug called imatinib given at a dose of 400mg. In this study the researchers would like to compare the effect of imatinib on CML and side effects, of using this standard drug at the usual dose of 400mg against the effect of using a higher dose of 800mg.
    A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.

    Complexity Level: 2

    Eligibility: Patients with chronic phase CML are eligible based on bone marrow aspirate, biopsy and peripheral blood counts obtained within 14 days before registration. Patients must have confirmed Philadelphia chromosome or variants of the (9-22) translation by cytogenetics or by FISH or be positive for BCR-ABL by RT-PCR. Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosomes. Patients must have a Zubroid performance status of 0 - 2. Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide. Patients must not have received prior chemotherapy for peripheral blood stem cell mobilization.

    Objectives: 1.1 To test whether increasing the dose of imatinib (STI571, Gleevec?) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase. 1.2 To estimate rates of cytogenetic and hematologic responses to each of the two imatinib dose levels. 1.3 To evaluate in a preliminary manner the prognostic effects of der(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib. 1.4 To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment. 1.5 To estimate the frequency and severity of toxicities of the two treatment regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00070499
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 30, 2005 Closing Date: February 28, 2009



    Permanently Closed
    CL1 (9011)A Phase III Comparison of Fludarabine Phosphate (NSC #312887) vs Chlorambucil vs Fludarabine Phosphate + Chlorambucil in Previously Untreated B-Cell Chronic Lymphocytic Leukemia

    A Phase III Comparison of Fludarabine Phosphate (NSC #312887) vs Chlorambucil vs Fludarabine Phosphate + Chlorambucil in Previously Untreated B-Cell Chronic Lymphocytic Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 08, 1991 Closing Date: December 07, 1994



    Permanently Closed
    CLC1E (CLC1E)A Canadian Economic Analysis of CLC.1

    A Canadian Economic Analysis of CLC.1

    Complexity Level: 3

    Eligibility: Tumour Type: CLL Line of Therapy: 1st line therapy Stage of Disease: Previously untreated, early-stage patients who are candidates for observation. Only patients ncluded in the randomized portion of this trial (those with the poor-risk molecular marker) will be included in the Economic Analysis.

    Objectives: Primary: Time to 2nd treatment; The primary outcome of the economic analysis is cost-utility. Utilities will be determined through use of the Euro QoL Eq5D questionnaire. Data to be obtained from Canadian patients includes health care-related resource utilization and lost productivity. Secondary: Overall survival; toxicity; correlative markers; QoL. Secondary outcomes of economic analysis: cost effectiveness related to 'years gained' prior to second therapy and if possible 'years gained'. Lost productivity of the two randomized groups will also be compared.

    NCT Registration ID (from clinicaltrials.gov): NA
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 13, 2009 Closing Date: December 24, 2009



    Permanently Closed

    Ind

    IDStudy TitleStatus
    I222A Phase I Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme
    The main purpose of this study is to determine the recommended phase II dose and safety profile of AZD2014 combined with standard temzolomide in patients with previously treated glioblastoma multiforme, and to estimate the 6 month progression-free rate and response in patients receiving AZD2014 in addition to their standard temozolomide treatment for the phase 2 portion. Secondary, to explore potential biomarkers such as PTEN, PI3KCA and other mutations, as well as evidence of pharmacodynamic effects in resected and archival tumour tissue.
    A Phase I Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme

    Complexity Level: 1

    Eligibility: Histologically confirmed glioblastoma multiforme that is recurrent after primary treatment, phase II must have measurable disease according to RANO criteria. ECOG 0-1. Radiation completed >= 4 weeks prior registration; surgery within 21 days (excluding resection). No clinically significant cardiac disease in last 12 months such as (coronary artery bypass graft, angioplasty, vascular stent, MI, congestive heart failure NYHA Grade 2, ventricular arrhythmias requiring continuous therapy, uncontrolled arrhythmias including atrial fibrillation, hemorrhagic or thrombotic stroke). No hepatitis B, hepatitis C, HIV or a prior history of tuberculosis, or diabetes type I or uncontrolled type II. No interstitial lung disease. No GI disease, meningeal or extracranial GBM involvement. No known QT/QTc-prolonging drugs. Stable or decreasing dose of corticosteroids. No enzyme inducing anticonvulsants. No medications that are metabolized by CYP3A4/5 5 and CYP2C8, Pgp (MDR1) and BCRP

    Objectives: Primary:To determine the recommended phase II dose (RP2D) of AZD2014 in patients receiving standard temozolomide treatment. To estimate the 6 month PFS rate in patients receiving AZD2014 in addition to their standard temozolomide treatment Secondary:To evaluate the plasma levels of AZD2014 alone at the time of resection. To assess the safety and toxicity profile of AZD2014 in patients receiving standard temozolomide treatment. To evaluate potential biomarkers such as PTEN, PI3KCA and other mutations, as well as evidence of pharmacodynamic effects in resected and archival tumour tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT02619864
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: January 13, 2016 Closing Date: October 19, 2018



    Closed to Accrual
    I109NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma

    NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma

    NCT Registration ID (from clinicaltrials.gov): NCT00003372
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 08, 1997 Closing Date: April 20, 2000



    Permanently Closed
    I142A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma
    The purpose of this study is to find out what effects the experimental drug SarCNU has on patients with malignant glioma. In addition, this study will evaluate the side effects of SarCNU. This research is being done because SarCNU has not been tested in brain tumours and it comes from a family of drugs which are known to be effective in some patients.
    A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma

    Eligibility: Patients with recurrent histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme). Patients with anaplastic astrocytoma may have had up to ONE prior chemotherapy regimen in the adjuvant setting, but NO chemotherapy for recurrence. Patients with glioblastoma multiforme must be chemotherapy-naive. Bidimensionally measurable enhancing lesions on CT or MRI.

    Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent malignant glioma. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

    NCT Registration ID (from clinicaltrials.gov): NCT00036660
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2002 Closing Date: December 17, 2002



    Permanently Closed
    I162A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma
    The purpose of this study is to find the highest dose of the drug RAD001C that can be given with standard doses of temozolomide without causing very severe side effects that are not tolerable.
    A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma

    Eligibility: Patients with newly diagnosed (no prior chemotherapy permitted) or recurrent (only one prior adjuvant chemo regimen permitted), glioblastoma multiforme (GBM). Bidimensionally measurable disease. Stable dose of steroids. Paraffin embedded tumour sample available for study.

    Objectives: To assess the toxicity, pharmacokinetics, efficacy, MTD, and RPII dose(s) of RAD001C when given in combination with standard dose of Temozolomide in patients with GBM. Patients receiving enzyme inducing anti-epileptic drugs (EIAEDs) and those not receiving EIAEDs will be studied separately.

    NCT Registration ID (from clinicaltrials.gov): NCT00387400
    Participation: Participation in this study is restricted to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 25, 2006 Closing Date: June 01, 2009



    Permanently Closed
    I204A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.
    The main purpose of this study is to find out how effective the experimental drug PX-866 is in treating glioblastoma multiforme. In addition, this study will look at the side effects of PX-866. Treatment with PX-866 will be once daily by mouth for an 8-week cycle. Researchers will also look at cancer cell markers from the patient's archival tissue sample.
    A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.

    Complexity Level: 2

    Eligibility: Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies. Must have formalin fixed paraffin embedded tissue available for translational studies. Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be > 1.0 cm). ECOG performance of 0, 1 or 2.Age > 18 years of age. Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBM

    Objectives: To determine the efficacy of PX-866 given orally daily in patients with glioblastoma at the time of first relapse or progression as assessed by objective response and early progression rates. To determine the safety and tolerability of PX-866 in patients with glioblastoma at first relapse/progression given in a daily oral schedule. To explore the relationship between objective response and molecular markers in archival tissue from glioblastoma patients treated with PX-866 orally daily.

    NCT Registration ID (from clinicaltrials.gov): NCT01259869
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 09, 2010 Closing Date: September 24, 2012



    Permanently Closed
    I170A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma

    A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma

    Eligibility: Patients with recurrent glioblastoma multiforme (GBM) following primary surgery and radiation. No prior chemotherapy for recurrent disease permitted. Bidimensionally measureable disease. Stable dose of steriods. Paraffin embedded tumour sample available for study.

    Objectives: To determine the toxicity, MAD, and RPII dose of GW572016 when given in patients with GBM taking CYP3A4 enzyme inducing anti-epileptic drugs. To assess the efficacy of GW572016 when administered daily in appropriate recommended doses to patients with recurrent GBM.

    NCT Registration ID (from clinicaltrials.gov): NCT00099060
    Participation: Participation in this study is restricted to invited centres.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 16, 2004 Closing Date: May 08, 2007



    Permanently Closed
    I48NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma

    NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 06, 1989 Closing Date: September 02, 1992



    Permanently Closed
    I94NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma

    NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 06, 1996 Closing Date: April 28, 1997



    Permanently Closed
    I27NCIC CTG Phase II Study of Trimetrexate in Glioma

    NCIC CTG Phase II Study of Trimetrexate in Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: March 14, 1988



    Permanently Closed
    I139A Phase II Study of T138067-Sodium in Patients With Malignant Glioma

    A Phase II Study of T138067-Sodium in Patients With Malignant Glioma

    Eligibility: Histologically proven malignant glioma (glioblastoma multiforme or anaplastic astrocytoma). Recurrent or progressive disease following primary surgery and radiation treatment. Up to ONE prior chemotherapy regimen in the adjuvant setting, no chemotherapy for recurrence. Stable dose of steriod for > 14 days prior to registration.

    Objectives: To determine the efficacy and toxicity of T138067-sodium in patients with recurrent malignant glioma when given as a weekly 3-hour infusion. To determine the pharmacokinetics of T138067-sodium in a subset of patients (6) enrolled on this study.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 08, 2000 Closing Date: January 09, 2002



    Permanently Closed
    I13NCIC CTG Phase II Study of N-methylformamide in Glioma

    NCIC CTG Phase II Study of N-methylformamide in Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1984 Closing Date: April 29, 1985



    Permanently Closed
    I75NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma

    NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 08, 1992 Closing Date: January 25, 1994



    Permanently Closed
    I54NCIC CTG Phase II Study of TCAR in Malignant Glioma

    NCIC CTG Phase II Study of TCAR in Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 18, 1990 Closing Date: May 28, 1991



    Permanently Closed
    I76NCIC CTG Phase II Study of Taxotere in Malignant Glioma

    NCIC CTG Phase II Study of Taxotere in Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1994 Closing Date: April 28, 1995



    Permanently Closed
    I239A Multicenter Phase Ib/II Study of a Polo-Kinase 4 Inhibitor CFI-400945 + the PD-L1 Inhibitor Durvalumab in Patients with Triple Negative Breast Cancer (TNBC)

    A Multicenter Phase Ib/II Study of a Polo-Kinase 4 Inhibitor CFI-400945 + the PD-L1 Inhibitor Durvalumab in Patients with Triple Negative Breast Cancer (TNBC)

    Complexity Level: 1

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    I237A Phase II Study of CFI-400945 in Patients with Advanced/Metastatic Breast Cancer
    The main purpose of this study is to determine the response to CFI-400945 in patients with advanced breast cancer, and to investigate disease control, safety and toxicity of CFI-400945 and the effects CFI-400945 has on cancer cells. Additional research will explore the relationship between certain genomic features and outcomes of treatment.
    A Phase II Study of CFI-400945 in Patients with Advanced/Metastatic Breast Cancer

    Complexity Level: 1

    Eligibility: Histologically and/or cytologically confirmed diagnosis breast cancer that is advanced/metastatic/recurrent or unresectable and either ER-, PR- and HER2- (COHORT 1) or ER+/PR+, HER2- and PTEN-null (COHORT 2) or ER+/PR+, HER2- and not PTEN-null (COHORT 3). FFPE tissue block available; select number of patients per cohort must have accessible disease suitable for biopsy. Presence of clinically/radiologically documented disease. ECOG 0 or 1. At least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, must have included anthracycline and taxane (unless contraindicated). No limit to number of prior regimens. May have received other therapies (i.e. endocrine therapy, immunotherapy, targeted therapies). HER2+ breast cancer not eligible; active or uncontrolled infections, serious illness, significant cardiac or pulmonary disease, history of CNS mets or spinal cord compression; concurrent treatment with other investigational drugs; treated with full dose warfarin.

    Objectives: Primary: To evaluate the objective response rate of CFI-400945 in patients with unresectable locally recurrent or metastatic breast cancer. Secondary: To estimate the Disease Control Rate (DCR, defined as CR or PR or stable disease (SD) >16 weeks in duration; to evaluate the safety and tolerability; to evaluate pharmacodynamics and cellular effects on tumour cells through paired tumour biopsies. Tertiary: To evaluate somatic genomic alterations and other molecular features (gene or protein expression levels) associated with response and/prolonged stable disease; to evaluate the association between PTEN status and response; to explore mechanisms of acquired resistance to CFI-400945 and clonal evolution in response to CFI-400945 treatment using cfDNA.

    NCT Registration ID (from clinicaltrials.gov): NCT03624543
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 21, 2018



    Open to Accrual
    I236A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination with Weekly Paclitaxel in Patients with Advanced/Metastatic HER2-Negative Breast Cancer
    The main purpose of this study is to determine the best dose of CFI-402257 when administered in combination with paclitaxel in patients with advanced breast cancer, and to investigate the safety and toxicity of CFI-402257+paclitaxel treatment as well as response and clinical benefit of this therapy. Additional research will investigate the effects CFI-402257+paclitaxel has on cancer cells, as well as explore the relationship between certain genomic features and outcomes of treatment.
    A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination with Weekly Paclitaxel in Patients with Advanced/Metastatic HER2-Negative Breast Cancer

    Complexity Level: 1

    Eligibility: Histologically and/or cytologically confirmed diagnosis breast cancer that is advanced/metastatic/recurrent or unresectable. Formalin fixed paraffin embedded tissue block available; select number of patients in Phase II must have accessible disease suitable for biopsy. Presence of clinically and/or radiologically documented disease. ECOG 0 or 1. Must have received at least one non-taxane containing chemotherapy regimen for advanced/metastatic disease, unless:relapsed within 6 mos of completion of adjuvant chemo;taxane and/or anthracycline containing adjuvant chemo or;contraindications to chemo other than weekly paclitaxel. Patients may not have had previous TTK/MPS1 inhibitor.Patients with HER2 positive breast cancer not eligible; active or uncontrolled infections, serious illness, significant cardiac or pulmonary disease, history of central nervous system mets or spinal cord compression; concurrent treatment with other investigational drugs; patients treated with full dose warfarin

    Objectives: Primary: Phase I - To establish the safety and tolerability of CFI-402257 given orally in combination with weekly paclitaxel and to identify the recommended Phase II dose (RP2D) in patients with advanced breast cancer. Phase II: To evaluate the anti-tumour activity of the CFI-402257+Paclitaxel combination when administered at the RP2D by determining Overall Response Rate (ORR). Secondary: To estimate the Clinical Benefit Rate (CBR, defined as CR or PR or stable disease (SD) >16 weeks in duration; to evaluate the safety and tolerability; to explore, if indicated, the PK profile of CFI402257 and paclitaxel. Exploratory: in serial tumour biopsies, explore evidence of pharmacodynamic target effect and estimate CFI402257 levels; evaluate the genomic alterations and other molecular features which may be associated with response and/or clinical benefit

    NCT Registration ID (from clinicaltrials.gov): NCT03568422
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: October 17, 2018



    On Hold
    I229A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab
    The main purpose of this study is to determine the best dose of durvalumab in patients with HER-2 positive metastatic breast cancer who are receiving trastuzumab, and to investigate the safety and toxicity of durvalumab when given with trastuzumab, as well as response and clinical benefit of this therapy. Additional research will investigate the effects durvalumab and trastuzumab have on cancer cells, as well as explore immune cell profiles both before and after treatment.
    A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab

    Complexity Level: 1

    Eligibility: Patients with histologically and/or cytologically confirmed HER-2 positive metastatic breast cancer. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. Patients enrolled to the RP2D / expansion cohort must have accessible disease suitable for biopsy and have consented to biopsy prior to treatment and at the end of cycle 1 (paired biopsies are recommended in all patients). Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have had prior exposure to a taxane, trastuzumab and pertuzumab and preferably also prior exposure to TDM-1 (no limit to number of prior regimens). Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active or prior autoimmune or inflammatory disorders, or history of primary immunodeficiency. No live attenuated vaccination on treatment or within 30 days of either registration or last dose.

    Objectives: PRIMARY - To determine the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab. SECONDARY - (1) To describe the toxicities of durvalumab in patients receiving trastuzumab; (2) To evaluate the response rate and clinical benefit rate of durvalumab (measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab; (3) To assess PD-L1 expression in paired biopsies pre and post treatment with durvalumab as a marker of response/benefit. EXPLORATORY - (1) To perform whole exome sequencing and RNAseq in paired biopsies (pre and post treatment) to explore biological correlates relative to PD-1/PD-L1 and trastuzumab and durvalumab exposure (minimum of 6 patients with paired biopsies); (2) To collect ctDNA as an exploratory marker; (3) To assess T cell and other immune cell subsets in paired biopsies pre and post treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT02649686
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: April 21, 2016 Closing Date: April 20, 2017



    Closed to Accrual
    I129A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer

    A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 14, 2000 Closing Date: March 02, 2001



    Permanently Closed
    I197A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.

    A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.

    Complexity Level: 2

    Eligibility: Advanced or recurrent/metastatic invasive breast cancer, that is ER, PR and HER2 negative.

    Objectives: To determine the anti-tumour activity and toxicity of foretinib in this patient population.

    NCT Registration ID (from clinicaltrials.gov): NCT01147484
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 25, 2010 Closing Date: August 02, 2013



    Permanently Closed
    I73NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer

    NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 27, 1992 Closing Date: February 28, 1995



    Permanently Closed
    I18NCIC CTG Phase II Study of Flutamide in Breast

    NCIC CTG Phase II Study of Flutamide in Breast

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 27, 1985 Closing Date: March 01, 1986



    Permanently Closed
    I19NCIC CTG Phase II Study of Menogaril in Breast

    NCIC CTG Phase II Study of Menogaril in Breast

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 30, 1985 Closing Date: March 15, 1986



    Permanently Closed
    I35NCIC CTG Phase II Study of CMF/Lonidamine in Breast

    NCIC CTG Phase II Study of CMF/Lonidamine in Breast

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 08, 1986 Closing Date: January 08, 1988



    Permanently Closed
    I45NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer

    NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 27, 1989 Closing Date: April 15, 1990



    Permanently Closed
    I60NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer

    NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 29, 1990 Closing Date: September 17, 1991



    Permanently Closed
    I97NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer

    NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 10, 1996 Closing Date: January 06, 1998



    Permanently Closed
    I93NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer

    NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 1996 Closing Date: September 24, 1998



    Permanently Closed
    I68NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer

    NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1992 Closing Date: June 30, 1993



    Permanently Closed
    I4BNCIC CTG Phase II Study of Lonidamine in Breast Cancer

    NCIC CTG Phase II Study of Lonidamine in Breast Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 01, 1983 Closing Date: May 13, 1985



    Permanently Closed
    I213A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer
    The main purpose of this study is to discover if adding reolysin to standard chemotherapy (paclitaxel) is as effective as standard chemotherapy (paclitaxel) alone. If patient is randomized to Arm A, they will be given reolysin by needle through a vein in their arm over 1 hour. Reolysin is given on days 1,2,8,9, 15 and 16 every 4 weeks. Paclitaxel will be given by needle into a vein over 1 hour on days 1, 8 and 15 every 4 weeks. If patient is randomized to Arm B, they will receive paclitaxel, given by needle into one of their veins over 1 hour on days 1, 8 and 15 every 4 weeks. Side-effects and safety of reolysin and paclitaxel in combination will be monitored. Additional research will investigate tissue samples from previously removed breast tissue.
    A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Patients with histoligical/cytological diagnosis of metastatic breast cancer, that is advanced and/or metastatic, with no curative therapy and for which systemic therapy is indicated. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. Patients must have received at least one prior chemotherapy regimen for advanced or metastatic disease, unless they have relapsed within 6 months of completion of adjuvant chemotherapy or they have received taxane and/or anthracycline containing adjuvant chemotherapy. ECOG 0-2. No neuropathy > grade 1.

    Objectives: Primary Objective: To evaluate the effect of reolysin in combination with standard paclitaxel chemotherapy on the progression free survival of patients with advanced or metastatic breast cancer Secondary Objectives: a) to determine the tolerability and toxicity of reolysin and paclitaxel when given in combination. b) to investigate additional potential measures of efficacy including: objective response rate, overall survival, CTC counts c) to explore potential molecular factors predictive of response by assessment of archival tumour tissue and CTCs, including EGFR and KRAS status.

    NCT Registration ID (from clinicaltrials.gov): NCT01656538
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 30, 2012 Closing Date: April 20, 2016



    Permanently Closed
    I198A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer

    A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer

    Complexity Level: 1

    Eligibility: Histologically confirmed diagnosis of invasive breast cancer, that is HER2 positive as assessed by FISH or ICH 3+ staining (in accordance with ASCO guidelines) on the basis of local evaluation of HER2 status.

    Objectives: To determine the recommended phase II dose (RP2D) of foretinib in combination with lapatinib, administered as a continuous daily oral dose, in patients with recurrent or metastatic HER2+ breast cancer. To evaluate the PK of lapatinib when given in combination with foretiib, preliminary evidence of anti-tumour activity, and to investigate the relationship between biomarkers and response.

    NCT Registration ID (from clinicaltrials.gov): NCT01138384
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 03, 2010 Closing Date: March 05, 2013



    Permanently Closed
    I164A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer
    The main purpose of this study is to find out what effects an experimental drug called OGX-011 has on patients with advanced breast cancer, when given in combination with a standard drug called docetaxel, and to find out the side effects (good or bad) these drugs cause when given together. As well, researchers will look at blood levels fo find out what effects OGX-011 has on specific markers.
    A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer

    Eligibility: Women with histologically documented breast cancer with metastatic or locally disease refractory to standard curative therapy. Prior adjuvant chemotherapy permissible; up to one prior chemotherapy regimen for metastatic disease and no prior taxane for metastatic disease. Prior hormonal therapy permitted, prior radiation therapy permitted if radiation involved <30% functioning bone marrow and >4 weeks. HER-2 positive patients may have had prior Herceptin treatment. ECOG 0,1,2. No brain metastases, no pre-existing neuropathy >= grade 2, no therapeutic anti-coagulation.

    Objectives: To determine the efficacy, as measured by objective tumour response rate, of weekly OGX-011 and q 3 weekly docetaxel when given in combination to patients with advanced breast cancer. To assess the adverse events, tolerability, time to progression and overall survival in this population. To measure evidence of OGX-011 effect on serum clusterin levels.

    NCT Registration ID (from clinicaltrials.gov): NCT00258375
    Participation: CAKO, CALM, CAMN, CAMP, CANL, CAVA, CAVF, CAVK
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 27, 2005 Closing Date: September 29, 2006



    Permanently Closed
    I163A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer

    A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer

    Eligibility: Patients with recurrent or metastatic breast cancer incurable by other means. Prior adjuvant as well as up to one prior regimen for recurrent/metastatic disease is permitted. Measurable disease. Paraffin embedded tumour sample available for study.

    Objectives: To evaluate, in parallel, the anti-tumour efficacy of two oral treatment schedules of RAD001C. To assess the adverse events, time to progression and response duration of RAD001C in patients with recurrent/metastatic breast cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00255788
    Participation: Participation in this study is restricted to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 19, 2005 Closing Date: January 11, 2007



    Permanently Closed
    I132A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer

    A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer

    Eligibility: Women with histologically documented advanced or metastatic breast cancer. Clinically and/or radiologically assessable disease. Unidimensional measurable disease. Prior adjuvant chemotherapy and/or up to two prior chemotherapy regimens for metastatic disease permitted.

    Objectives: To assess the efficacy (measured by objective tumour response) of temozolomide when given in this schedule in this patient population. To determine the duration of response, time to progression and the toxic effects of temozolomide when administered in this fashion.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 2000 Closing Date: September 26, 2001



    Permanently Closed
    I208Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination with Panitumumab in Patients with Metastatic or Advanced RAS-Wild Type Colorectal Cancer.
    The main purpose of this study is to determine the recommended dose of BKM120 in combination with panitumumab therapy and to determine the safety, tolerability, adverse events (side effects) and dose limiting events of BKM120 and panitumumab. Additional research will investigate tissue samples from previously removed melanoma lesions by looking and response rates and early progression rates and the correlation, if any between response and certain biomarkers in the archival tumour tissue.
    Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination with Panitumumab in Patients with Metastatic or Advanced RAS-Wild Type Colorectal Cancer.

    Complexity Level: 1

    Eligibility: Patients with histologic proof of a primary colorectal cancer which is recurrent or metastatic. Tumour must be K-Ras wild type by means of mutation analysis and patient must have a representative sample of tumour tissue available. Patient must have failed, or have been unable to receive prior irinotecan, oxaliplatin and thymidylate synthase inhibitor therapy. Phase I-patients may have measureable or non-measurable disease. Phase II-patients must have measureable disease. At least 4 weeks since major surgery, chemotherapy, investigational agent or radiation therapy. ECOG 0-2. Age > 18 years.

    Objectives: Phase I-To determine the recommended phase II dose of BKM120 in combination with standard panitumumab therapy and determine the safety, tolerability, toxicity profile and dose limiting toxicities. Phase II-To assess the anti-tumour activity as evidenced by response rates and early progression and investigate the correlation, if any, between response and molecular biomarkers in archival FFPE tumour.

    NCT Registration ID (from clinicaltrials.gov): NCT01591421
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: May 01, 2012 Closing Date: July 14, 2015



    Closed to Accrual
    I112NCIC CTG Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Locally Advanced or Metastatic Colorectal Cancer

    NCIC CTG Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Locally Advanced or Metastatic Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 11, 1998 Closing Date: September 29, 1999



    Permanently Closed
    I146A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
    The purpose of this study is to find out what effects the experimental drug SarCNU has on bowel cancer. In addition, this study will evaluate the side effects of SarCNU. This research is being done because SarCNU has not been tested in bowel cancer and it comes from a family of drugs which are known to be effective in some patients.
    A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer

    Eligibility: Histologically proven colorectal cancer, either locally recurrent or metastatic following first-line chemotherapy for recurrent/metastatic disease. Clinically or radiological documented unidimensional measurable disease (RECIST criteria). Must have received one previous chemotherapy regimen for recurrent/metastatic disease. Prior nitrosourea not permitted.

    Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent/metastatic colorectal cancer. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

    NCT Registration ID (from clinicaltrials.gov): NCT00028015
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 30, 2001 Closing Date: August 14, 2003



    Permanently Closed
    I58NCIC CTG Phase II Study of DuP 937 in Patients With Colorectal Cancer

    NCIC CTG Phase II Study of DuP 937 in Patients With Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1991 Closing Date: November 10, 1991



    Permanently Closed
    I9NCIC CTG Phase II Study of TCAR in Colon

    NCIC CTG Phase II Study of TCAR in Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1985 Closing Date: March 05, 1986



    Permanently Closed
    I135A Phase I/II Study Of CPT-11 (Irinotecan), Oxaliplatin and Raltitrexed (COT) in Patients With Advanced Colorectal Cancer

    A Phase I/II Study Of CPT-11 (Irinotecan), Oxaliplatin and Raltitrexed (COT) in Patients With Advanced Colorectal Cancer

    Eligibility: Histologically documented colon or rectal cancer that is metastatic or locally recurrent.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of COT given as intravenous infusions on day 1 every 3 weeks. To determine the toxic effects of COT. To determine the pharmacokinetics IF the toxicity of the combined regimen is not in keeping with the toxicity expected from single or double agent studies. To assess clinical response rates of the combination.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 28, 2000 Closing Date: February 07, 2002



    Permanently Closed
    I23NCIC CTG Phase II Study of Acivicin in Colon

    NCIC CTG Phase II Study of Acivicin in Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 17, 1985 Closing Date: April 28, 1986



    Permanently Closed
    I1CNCIC CTG Phase II Study of Acivicin (AT125) in Colorectal Cancer

    NCIC CTG Phase II Study of Acivicin (AT125) in Colorectal Cancer

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 03, 1981 Closing Date: May 31, 1982



    Permanently Closed
    I8NCIC CTG Phase II Study of N-methylformamide in Colon

    NCIC CTG Phase II Study of N-methylformamide in Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 1984 Closing Date: April 29, 1985



    Permanently Closed
    I98NCIC CTG Phase I/II Study of Tomudex and Doxorubicin in Patients With Locally Advanced, Inoperable or Metastatic Gastric Cancer

    NCIC CTG Phase I/II Study of Tomudex and Doxorubicin in Patients With Locally Advanced, Inoperable or Metastatic Gastric Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 24, 1996 Closing Date: April 07, 1999



    Permanently Closed
    I90NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer

    NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 12, 1995 Closing Date: June 21, 1996



    Permanently Closed
    I210A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.
    The main purpose of this study is to discover if adding reolysin to standard chemotherapy (FOLFOX6/Bevacizumab) is as effective as standard chemotherapy (FOLFOX6/Bevacizumab) alone by looking at changes in CEA levels and amount of disease. On both arms the FOLFOX6 /Bevacizumab are given as a combination of drugs which are given together on day one, and then followed by a continuous infusion through a portable pump over the next 46 hours, also every 2 weeks. On the experimental arm, Reolysin will be given by intravenous injection over 1 hr on days 1-5 for cycles 1,2,4 6, and every second cycle after that, after the FOLFOX6/Bevacizumab infusion. (one cycle is 2 weeks) Side-effects and safety of reolysin and FOLFOX6/Bevacizumab in combination will be monitored. Additional research will investigate tissue samples from previously removed colorectal tissue.
    A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.

    Complexity Level: 2

    Eligibility: Patients with a histological diagnosis of metastatic colorectal adenocarcinoma. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. No prior chemotherapy for metastatic disease. Prior adjuvant fluropyrimidine based therapy is permitted >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function. No neuropathy > grade1

    Objectives: 1. To evaluate the effect of reolysin in combination with standard FOLFOX6 chemotherapy of the progression free survival of patients with advanced or metastatic colorectal cancer. 2a. To determine the tolerability and toxicity of reolysin and FOLFOX6/Bevacizumab when given in combination. 2b. To investigate additional potential measures of efficacy including:change in CEA levels; objective response rate; evaluate the effect of both treatments on overall survival (OS) 2c.To explore potential molecular factors that may be prognostic or predictive of response by assessment of archival tumour tissue and serial blood samples 2d.To explore the Quality of Life (as measured by the EORTC QLQC30)

    NCT Registration ID (from clinicaltrials.gov): NCT01622543
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 11, 2012 Closing Date: February 12, 2015



    Permanently Closed
    I187A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer
    The main purpose of this study is to find out what dose of an experimental drug called AZD2281 is safe to give to patients with advanced cancer in combination with another drug called Irinotecan without too many side-effects. Researchers will also look at blood levels to find out how the drug is distributed in the blood and will also investigate epithelial cells, previously removed tumour sample and new tumour biopsies (optional) to see what effects the drug will have on these samples.
    A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer

    Complexity Level: 1

    Eligibility: Patients with histologically or cytologically documented colorectal cancer and must have locally advanced and/or metastatic colorectal cancer that is considered incurable and suitable for treatment with single agent irinotecan as a palliative intervention by the investigator. No anti-cancer treatment <= 21 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No GI tract disease resulting in an iability to adsorb oral medication.

    Objectives: 1.1 To determine the recommended phase II dose of irinotecan given on day 1 by 90 minute infusion every 21 days with a biologically active dose of AZD2281 given orally bid continuously, in patients with locally advanced or metastatic incurable colorectal cancer. 1.2 To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of the combination of AZD2281 and irinotecan in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. 1.3 To assess preliminary evidence of the anti-tumour activity of AZD2281 in combination with irinotecan in patients with colorectal cancer with measurable disease. 1.4 To demonstrate the pharmacodynamic activity of AZD2281 in combination with irinotecan by establishing its effects in tumour biopsies, cheek swabs and blood samples. 1.5 To assess the correlation, if any, between patients with tumours demonstrating microsatellite instability and anti-tu

    NCT Registration ID (from clinicaltrials.gov): NCT00535353
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 13, 2007 Closing Date: March 08, 2012



    Permanently Closed
    I175A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer
    The main purpose of this study is to find out what dose of an experimental drug called AZD2171 is safe to give to patients with advanced non-small cell lung cancer (NSCLC), when given in combination with a standard drugs called gemcitabine and cisplatin, and to find out what dose of this experimental drug called AZD2171 is safe to give to patients with advanced colorectal cancer when given in combination with a standard treatment called FOLFOX-6 (oxaliplatin, fluoruracil and leucovorin). As well, researchers will look at the side effects (good or bad) these drugs in combination cause when given all together. As well, researchers will look at blood levels fo find out how the drug combinations affect how the AZD2171 is distributed in the blood.
    A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer

    Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; at least 14 days since major surgery; no prior therapy with angiogenesis inhibitor. ECOG PS of 0,1 OR 2. No uncontrolled hypertension or CVD. No peripheral neuropathy > grade 1. Adequate bone marrow reserve and renal and liver function. For NSCLC: maximum of one prior single agent non-platinum chemotherapy for metastatic disease; no prior gemcitabine therapy. For colorectal: suitable for first line therapy with FOLFOX-6; no prior oxaliplatin patients with DPD deficiency or history of severe hand- foot syndrome from fluoropyrimidines are not eligible.

    Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colorectal cancer. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. To assess the anti-tumour activity of AZD2171 in combination with standard chemotherapy regimens in patients with measurable disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00343408
    Participation: Limited to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 08, 2005 Closing Date: March 30, 2007



    Permanently Closed
    I173A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic Cancer

    A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic Cancer

    Eligibility: Patients with unresectable, locally advanced or metastatic pancreatic cancer. No prior chemo therapy permitted except for 5FU(+/-folinic acid) or gemcitabine given concurrently with radiation.

    Objectives: To determine the toxicity and RPII dose of AZD0530 when given in combination with Gemcitabine in patients with pancreatic cancer. To assess the efficacy of AZD0530 in combination with Gemcitabine in patients with pancreatic cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00265876
    Participation: Participation is limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 19, 2005 Closing Date: May 29, 2008



    Permanently Closed
    I171A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination with Standard Chemotherapy Regimens (CT) in Patients with Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumour Types Suitable for Treatment with Capecitabine

    A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination with Standard Chemotherapy Regimens (CT) in Patients with Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumour Types Suitable for Treatment with Capecitabine

    Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer or other tumour types with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; 14 days since major surgery; no prior therapy with angiogenesis inhibitor. For NSCLC: maximum of 1 prior single agent non-platinum chemotherapy for metastatic disease; no prior taxane therapy; no peripheral neuropathy > grade 1. For colorectal: suitable for first line therapy with capecitabine; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines. For other tumour types: suitable for treatment with capecitabine; patients with no more than 2 prior chemotherapy; LVEF >50% if prior anthracyclines/trastuzumab/cardiotoxic agents; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines.

    Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colon cancer or other tumour types suitable for treatment with capecitabine and to determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. Also to assess the anti-tumour activity of AZD2171 in patients with measurable disease and to correlate patient outcomes (response) with baseline (tumour) and serial (urine and plasma) biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT00107250
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 13, 2005 Closing Date: February 17, 2009



    Permanently Closed
    I168A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
    The purpose of this study is to find out what effects an experimental drug, SB-715992, will have on primary liver cancer (hepatocellular carcinoma). In addition this study will evaluate the side effects of SB-715992, its blood levels, and in some patients who consent to special laboratory studies, the effect of the drug in white blood cells. As well, researchers will look at tumour tissue samples (samples from patients who have had liver cancer tissue previously removed) to learn about which types of primary liver cancer are most likely to be affected by SB-715992. Patients who meet all of the eligibility criteria will be given SB-715992 by needle into a vein once every 3 weeks.
    A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma

    Eligibility: Patients with histologically or cytologically documented hepatocellular carcinoma with locally advanced, recurrent or metastatic disease. Unidimensionally measurable disease by RECIST criteria. Prior intra-hepatic chemotherapy permitted; no prior systemic chemotherapy permitted. Patients must be > 4 weeks since major surgery, radiation therapy, local ablative therapy or intra-hepatic chemotherapy and must have hepatic reserve of Child-Turcotte-Pugh Class A or better. Patients with histological diagnosis must have archival tumour specimen available for correlative study.

    Objectives: To assess the efficacy (response rate and stable disease rate) of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma. To assess the toxicity of SB-715992 in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma, as well as early progression rate, and, if responses are observed, response duration. To characterize the population pharmacokinetic (PK) parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints. To describe the relationship between tumour expression of B-tubulin and KSP in archival paraffin fixed tumour tissue with clinical outcome of treatment with SB-715992. In a subset of separately consenting patients, to describe the changes in molecular markers of SB-715992 effect in PBMCs.

    NCT Registration ID (from clinicaltrials.gov): NCT00095992
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 24, 2004 Closing Date: May 04, 2006



    Permanently Closed
    I223A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer
    The purpose of this study is to find out what effects a new drug, palbociclib, has on prostate cancer and will look at the side effects of treatment with palbociclib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by palbociclib and to see how the cancer cells respond to palbociclib.
    A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer

    Complexity Level: 1

    Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients will be pre-screened for CCDN1 amplification and RB1 status. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed. Potent/strong CYP3A inhibitors/inducers not allowed.

    Objectives: PRIMARY - To assess the clinical benefit rate (CBR) of palbociclib in patients with metastatic, castration-resistant prostate cancer (mCRPC). SECONDARY - (1) To determine the effect of palbociclib on PSA decline and time to PSA progression; (2) To determine objective response as determined by RECIST 1.1 criteria; (3) To evaluate the safety and toxicity profile of palbociclib in mCRPC patients. EXPLORATORY - (1) To determine whether CCND1 gain/amplification in plasma cell-free DNA (cfDNA) (+/-RB1 wild type) is predictive of CBR to palbociclib; (2) To evaluate gene copy number variation and mutation profile of cfDNA in patients with mCRPC before and after treatment with palbociclib; (3) To identify potential predictive and prognostic blood-based RNA markers.

    NCT Registration ID (from clinicaltrials.gov): NCT02905318
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: February 09, 2017



    Open to Accrual
    I234DA Phase II Study of CFI-400945 Fumarate in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
    The purpose of this study is to find out what effects a new drug, CFI-400945, has on prostate cancer and will look at the side effects of treatment with CFI-400945. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by CFI-400945 and to see how the cancer cells respond to CFI-400945.
    A Phase II Study of CFI-400945 Fumarate in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.234. All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.

    Objectives: Primary Objectives To determine the effect of CFI-400945 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. To evaluate the safety and toxicity profile of CFI-400945 in mCRPC patients.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 12, 2017



    Open to Accrual
    I234CA Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234
    The purpose of this study is to find out what effects a new drug, darolutamide, has on prostate cancer and will look at the side effects of treatment with darolutamide. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by darolutamide and to see how the cancer cells respond to darolutamide.
    A Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Serum potassium within normal limits. Prior abiraterone acetate or enzalutamide but not both. No prior cytotoxic systemic chemotherapy in the CRPC setting.

    Objectives: To determine the effect of darolutamide on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of darolutamide in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 12, 2017



    Open to Accrual
    I234Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol
    The purpose of the pre-study screening is to test for DNA abnormalities or "markers". This testing will be done on a sample of your blood to see whether or not you are eligible to take part in one of the main studies. Each study will be looking at what effects a new drug or drugs has on you and your prostate cancer and will also be looking at the side effects of treatment. The researchers doing the main studies will be looking to see if the "markers" that were identified in your screening sample can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to it/them.
    Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol

    Complexity Level: 1

    Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients must consent to undergo genomic screening. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed.

    Objectives: Primary Objective - To centrally genotype cfDNA from patients with mCRPC progressing after a "next-generation" AR-pathway inhibitor in order to facilitate accrual to targeted therapy trials and then to assess the clinical benefit rate (CBR), of each Study Drug. Secondary Objectives - To determine the effect of each Study Drug on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of each Study Drug in mCRPC patients. Tertiary Objectives - To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 12, 2017



    Open to Accrual
    I234BA Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
    The purpose of this study is to find out what effects a new drug, savolitinib, has on prostate cancer and will look at the side effects of treatment with savolitinib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by savolitinib and to see how the cancer cells respond to savolitinib.
    A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234.Men of childbearing potential must have agreed to use a highly effective contraceptive method during Study Drug treatment and for 6 months after stopping treatment and should not father a child or donate sperm during this period. Patients with significantly abnormal liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis are not eligible. Patients in whom strong inducers or inhibitors of CYP3A4 and strong inhibitors of CYP1A2 cannot be discontinued within 2 weeks before the first dose of savolitinib (3 weeks for St John's Wort) are not eligible..

    Objectives: To determine the effect of savolitinib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of savolitinib in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 12, 2017



    Open to Accrual
    I232A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

    A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed adenocarcinoma of the prostate that is castrate resistant. Must have disease progression either PSA, objective or both as well as surgical or medical castration with testosterone levels <50mg/dL. An available tissue block from primary or metastatic tumour as well as accessible disease suitable for fresh biopsy and consent to biopsy prior to treatment is required. Patients must have measurable disease per RECIST 1.1. Patients may have received prior treatment with docetaxel chemotherapy, tyrosine kinase or other targeted agents. Failure/progression on abiraterone and/or enzalutamide is required. Antiandrogens must have been discontinued for < 4 weeks prior to study entry (6 weeks for bicalutamide). No prior immunotherapy or vaccines, treatment with oncolytics viruses is permissible. No prior history of immunodeficiency, or use or immunosuppressive agents within 28 days of randomization.

    Objectives: Primary - To determine the objective response rate (RECIST 1.1 and irRECIST) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with durvalumab alone or in combination with tremelimumab. Secondary - To determine the prostate-specific antigen (PSA) response rate as time to PSA progression; To evaluate time to objective disease progression; To evaluate the toxicity and tolerability of durvalumab alone or in combination with tremelimumab. Exploratory - To explore the utility of tissue and blood based biomarkers to select patients for treatment with durvalumab alone or in combination with tremelimumab.

    NCT Registration ID (from clinicaltrials.gov): NCT02788773
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: August 18, 2016



    On Hold
    I234AA Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
    The purpose of this study is to find out what effects a new drug, AZD1775, has on prostate cancer and will look at the side effects of treatment with AZD1775. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by AZD1775 and to see how the cancer cells respond to AZD1775.
    A Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients without history of hypersensitivity to AZD1775 or any of its excipients or who have not received treatment with drugs with a similar mechanism of action. Patients witout any factors that increase the risk of QTc prolongation or risk of arrhythmic events or mean resting corrected QT interval (QTc) <= 470 msec. Patients on drugs with a narrow therapeutic index which are substrates of BRCP, PGP, CYP2C19 or CYP1A2, inhibitors of PGP, and which cannot be discontinued or changed to alternative drugs are not eligible.

    Objectives: To determine the effect of AZD1775 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of AZD1775 in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: December 12, 2017



    On Hold
    I128NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy

    NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 03, 1999 Closing Date: May 01, 2001



    Permanently Closed
    I195A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer
    The main purpose of this study is to find out how effective the experimental drug SB939 is in treating prostate cancer. In addition, this study will look at the side effects of SB939. Treatment will be SB939 once daily by mouth 3 times a week (every other day) for the first three weeks and then one week off. Researchers will also look at cancer cell markers from the patient's tissue sample as well as SB939 levels in Circulating Tumour Cells.
    A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. Up to 1 prior chemotherapy regimen is permitted. ECOG 0 or 1. Adequate cardiac function and acceptable end-organ function.

    Objectives: 1.1 The primary objective of this study is to determine the efficacy (as measured by PSA response and progression free survival) of SB939 when given orally every other day 3 times a week, in patients with castration resistant prostate cancer, who have received 0-1 prior chemotherapy regimens. 1.2 To determine objective response and response duration in patients with measurable disease at baseline. 1.3 To determine the tolerability and toxicity of SB939 in this population. 1.4 Enumeration of Circulating Tumour Cells (CTC) at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment) using two methodologies. 1.5 To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue. 1.6 To explore the utility of ERG and PTEN expression on circulating tumour cells as a potential prognostic and predictive marker for response to SB939. 1.7 To describe time to PSA and time to objective progression in patients treated with SB939.

    NCT Registration ID (from clinicaltrials.gov): NCT01075308
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2010 Closing Date: November 04, 2011



    Permanently Closed
    I209A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer
    The main purpose of this study is to discover if adding reolysin to standard chemotherapy (docetaxel/prednisone) is as effective as standard chemotherapy (docetaxel/prednisone) alone by looking at changes in PSA levels, CTCs and amount of disease. On both arms the docetaxel will be given by intravenous injection over 1 hr day 1 every three weeks and prednisone will be taken by mouth twice a day for 21 days. On the experimental arm, Reolysin will be given by intravenous injection over 1 hr on days 1-5 every three weeks, after the docetaxel infusion. Side-effects and safety of reolysin and docetaxel in combination will be monitored. Additional research will investigate tissue samples from previously removed prostate tissue.
    A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Tumour block available. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. No prior chemotherapy for recurrent/metastatic disease. No prior docetaxel unless given adjuvantly and >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function.

    Objectives: 1. To evaluate efficacy which will be based on the lack of disease progression measured at 12 weeks. 2a. To determine the tolerability and toxicity of Reolysin and docetaxel when given in combination. 2b. To investigate additional potential measures of efficacy including CTC status, CTC conversion rate, change in PSA levels, Objective response rate and effect of both treatments on overall survival. 2c. Explore potential molecular factors predictive of response in archival tumour and baseline CTCs.

    NCT Registration ID (from clinicaltrials.gov): NCT01619813
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 11, 2012 Closing Date: September 25, 2015



    Permanently Closed
    I38NCIC CTG Phase II Study of TNF in Renal Cell

    NCIC CTG Phase II Study of TNF in Renal Cell

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1988 Closing Date: September 01, 1989



    Permanently Closed
    I140A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer
    This research is being done because currently there is no effective treatment for this type of cancer. Both doses of Iressa? have shown some anticancer effect in early human studies. Therefore we want to know which dose will be effective with the fewest side effects.
    A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer

    Eligibility: Prostate cancer patients with evidence of progression by rising PSA or progressive measurable disease on androgen ablative therapy; PSA > 20 ng/mL; chemo-naive; minimally symptomatic disease.

    Objectives: To determine the efficacy, and toxicity of two different doses of ZD1839 (250 mg or 500 mg) in patients with hormone refractory prostate cancer. Objective response where applicable, PSA response and duration of these responses, will be measured.

    NCT Registration ID (from clinicaltrials.gov): NCT00025116
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 2001 Closing Date: April 25, 2002



    Permanently Closed
    I111A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer

    A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 12, 1998 Closing Date: January 22, 1999



    Permanently Closed
    I4NCIC CTG Phase II Study of Lonidamine in Hypernephroma

    NCIC CTG Phase II Study of Lonidamine in Hypernephroma

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1982 Closing Date: May 05, 1984



    Permanently Closed
    I6NCIC CTG Phase II Study of Interferon in Renal Cell Cancer

    NCIC CTG Phase II Study of Interferon in Renal Cell Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 01, 1983 Closing Date: September 20, 1984



    Permanently Closed
    I24NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell

    NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 06, 1985 Closing Date: November 26, 1986



    Permanently Closed
    I119A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

    A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 16, 1999 Closing Date: March 21, 2000



    Permanently Closed
    I46NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma

    NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 25, 1989 Closing Date: May 11, 1990



    Permanently Closed
    I95NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract

    NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 06, 1996 Closing Date: October 03, 1997



    Permanently Closed
    I88A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma

    A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 03, 1995 Closing Date: April 29, 1997



    Permanently Closed
    I70NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma

    NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 24, 1992 Closing Date: February 03, 1993



    Permanently Closed
    I49NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma

    NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 19, 1990 Closing Date: November 30, 1990



    Permanently Closed
    I205A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).

    A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).

    Complexity Level: 2

    Eligibility: Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration. Either:PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of >= 5 ng/ml and must be performed no longer than 7 days prior to trial registration.OR Radiological Progression. The PSA must be >=5 ng/ml at the time of study entry. ECOG performance of 0, 1 or 2; Age > 18 years of age. All patients must have formalin fixed paraffin embedded tissue. Presence of clinically and/or radiologically documented disease.

    Objectives: To determine the efficacy of PX-866 when given orally daily in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease.To determine the tolerability and toxicity. of PX-866 in this population. To investigate additional potential measures of efficacy including: PSA response rate, Objective response rate, Change in circulating tumour cell number during treatment. To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue and baseline circulating tumour cells. In selected participating centres, to determine evidence of effect on PI3K activation pre- and post administration of PX-866 in platelets

    NCT Registration ID (from clinicaltrials.gov): NCT01331083
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 2011 Closing Date: January 10, 2014



    Permanently Closed
    I143A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

    A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

    Eligibility: Patients with recurrent or metastatic renal cell carcinoma. No prior chemotherapy or immunotherapy for advanced/recurrent disease. Clinically and/or radiologically documented unidimensionally measurable disease.

    Objectives: To evaluate the efficacy and safety of MG98 when given as a 2-hour IV infusion twice weekly for 3 out or every 4 weeks in patients with advanced and/or metastatic renal cell carcinoma.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 2001 Closing Date: May 10, 2002



    Permanently Closed
    I153A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
    Patients who have been diagnosed with adenocarcinoma of the prostate, meet all of the eligibility requirements and are potential candidates for radical prostatectomy will receive OGX-011 will be administered intravenously over 2 hours on days 1, 3, 5, 8, 15, 22, 29. Patients will also be given buserelin day one and daily oral flutamide for the 29 days. Radical prostatectomy surgery will be scheduled within 7 days after the last dose of OGX-011.
    A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer

    Eligibility: Histologically confirmed adenocarcinoma of the prostate. No prior treatment. Must be a potential candidate for radical prostatectomy. Minimum 2 positive biopsies and at least one of the following: clinical stage T3; serum PSA > 10 ng/ml; Gleason score 7-10 or Gleason score 6 and >= 3 positive biopsies

    Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 administered days 1, 3, 5, 8, 15, 22 and 29 intravenously with neoadjuvant hormone therapy prior to radical prostatectomy. To determine the plasma pharmacokinetic profile To determine the tissue concentration of OGX-011 in radical prostatectomy specimens. To measure evidence of effect on clusterin expression in peripheral blood mononuclear cells and clusterin serum levels. To assess the effect of the combined hormone and OGX-011 therapy on com[plete response rates. To attempt to establish correlations between palsma and or prostate concentrations of OGX-011 with patient response or toxicity.

    NCT Registration ID (from clinicaltrials.gov): NCT00054106
    Participation: Limited to one centre: BCCA-Vancouver
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 06, 2002 Closing Date: May 05, 2004



    Permanently Closed
    I167Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer
    The main purpose of this study is to find out what effects an experimental drug called BAY43-9006 has on patients with prostate cancer which has stopped responding to hormone therapy, and to find out the side effects (good or bad) the drug causes. As well, researchers will look at tumour tissue samples (from a sample of the tumour that was removed at the time of the initial diagnosis) to find out what effects BAY43-9006 has on individual cancer cells. Patients who meet all of the eligibility criteria will be given a supply of BAY43-9006 pills to take one every day. Treatment will be repeated every 4 weeks.
    Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer

    Eligibility: Patients with histologically or cytologically diagnosed prostate cancer that is advanced and non-curable with standard therapy. PSA progression with PSA>10 ng/mL at study entry. Primary tumour available for immunohistochemistry. No prior chemotherapy. Minimally symptomatic disease.

    Objectives: To determine PSA response rate. To determine objective response rate and duration of response as measured by RECIST. To determine the tolerability and toxicity of BAY 43-9006 given to this patient population. To describe time to treatment failure and overall patient survival. To correlate the relationship between tumour markers and patients with response and with non-progression.

    NCT Registration ID (from clinicaltrials.gov): NCT00093457
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2004 Closing Date: December 20, 2005



    Permanently Closed
    I165A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.
    A phase II study for patients with advanced prostate cancer who have become hormone refractory following previous treatment. Patients will be randomized (50-50 chance) to receive either Arm A (OGX-011, docetaxel and prednisone) or Arm B (docetaxel and prednisone). Patients will receive treatment for up to 10 cycles (approx. 30 weeks) as long as their disease does not get worse, they do not have serious side effects and they wish to continue.
    A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.

    Eligibility: Histologically or cytologically diagnosed prostate cancer with documented evidence of progression by rising PSA (>5 ng/mL at baseline). Patients must have metastatic or locally recurrent disease for which no curative therapy exists and for which systemic chemotherapy is indicated due to progression while receiving androgen ablative therapy. No prior chemotherapy except estramustine. Prior hormone therapy permitted but must be refractory and discontinued > 4 weeks (6 wks for bicalutamide). Prior radiation permitted if > 4 weeks. ECOG 0, 1, 2. Adequate organ function. No pre-existing neuropathy >= grade 2 or therapeutic anti-coagulation.

    Objectives: To determine the efficacy, as measured by PSA response and duration of response, of weekly OGX-011 administered intravenously in combination with q 3 weekly docetaxel and prednisone, or docetaxel and prednisone in patients with HRPC. To determine objective response and duration in those with measurable disease at baseline. To determine tolerability and toxicity when given in this schedule. To measure evidence of OGX-011 and docetaxel or docetaxel effect on serum clusterin levels. To describe time to progression and overall patient survival for both cohorts.

    NCT Registration ID (from clinicaltrials.gov): NCT00258388
    Participation: Limited to selected centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 27, 2005 Closing Date: December 21, 2006



    Permanently Closed
    I161A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

    A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

    Eligibility: Patients with histologically or cytologically documented renal cell cancer that is locally recurrent or metastatic. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. No prior systemic chemotherapy regimens. Previous interferon permitted > 3 months prior to study entry. No immunotherapy for advanced/recurrent disease. No gene therapy. Known HIV-positive patients are not permitted nor patients with known glucose-6 phosphate dehydrogenase deficiency.

    Objectives: To assess the efficacy (objective response rate) of Triapine given as a 2-hour IV infusion for 4 consecutive days every other week to patients with recurrent/ metastatic renal cell cancer who have received no prior systemic therapy for recurrence. To determine adverse events and tolerability of Triapine in this patient population. To describe time to disease progression and overall patient survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00075660
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 16, 2004 Closing Date: April 05, 2005



    Permanently Closed
    I102NCIC CTG Phase II Study of BMS-182751 (JM-216) in Patients With Advanced and/or Recurrent Squamous Cell Carcinoma of the Cervix

    NCIC CTG Phase II Study of BMS-182751 (JM-216) in Patients With Advanced and/or Recurrent Squamous Cell Carcinoma of the Cervix

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1997 Closing Date: February 16, 1999



    Permanently Closed
    I106NCIC CTG Phase II Study of Topotecan/Cisplatin/Paclitaxel as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

    NCIC CTG Phase II Study of Topotecan/Cisplatin/Paclitaxel as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 10, 1997 Closing Date: May 07, 1998



    Permanently Closed
    I51NCIC CTG Phase I Study of GM-CSF + Carboplatin/Cyclophosphamide in Ovary

    NCIC CTG Phase I Study of GM-CSF + Carboplatin/Cyclophosphamide in Ovary

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 29, 1989 Closing Date: February 10, 1990



    Permanently Closed
    I12NCIC CTG Phase II Study of CBDCA in Ovary

    NCIC CTG Phase II Study of CBDCA in Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1984 Closing Date: February 21, 1985



    Permanently Closed
    I51ANCIC CTG Phase I Study of GM-CSF Plus Carboplatin in Ovary

    NCIC CTG Phase I Study of GM-CSF Plus Carboplatin in Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 1990 Closing Date: September 28, 1990



    Permanently Closed
    I25NCIC CTG Phase II Study of Trimetrexate in Ovary

    NCIC CTG Phase II Study of Trimetrexate in Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: May 02, 1988



    Permanently Closed
    I185A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma
    The main purpose of this study is to find out what effects an experimental drug called Sunitinib has on patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, and to find out the side effects (good or bad) the drug causes. Patients who meet all of the eligibility criteria will take sunitinib orally daily for 4 weeks with a two week break. Treatment will be repeated every 6 weeks.
    A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma

    Eligibility: Patients with histological documented epithelial ovarian, fallopian tube carcinoma or primary peritoneal cancer (advanced or metastatic disease). Minimum of 1 and maximum of 2 prior chemotherapy regimens, one of which must be platinum containing.

    Objectives: To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma. To document CA125 response rate, early objective progression rate, and, if objective responses are observed, response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00388037
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 10, 2006 Closing Date: April 17, 2008



    Permanently Closed
    I184A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical Carcinoma
    The main purpose of this study is to find out what effects an experimental drug called Sunitinib has on patients with unresectable, locally advanced or metastatic cervical carcinoma, and to find out the side effects (good or bad) the drug causes. Patients who meet all of the eligibility criteria will take sunitinib orally daily for 4 weeks with a two week break. Treatment will be repeated every 6 weeks.
    A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical Carcinoma

    Eligibility: Patients with histological/cytological documented squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix (advanced, recurrent or persistent disease). Maximum of 1 prior chemotherapy regimen for metastatic disease. Prior neoadjuvant, adjuvant or concurrent chemoradiartion is permitted.

    Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00389974
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 09, 2006 Closing Date: May 12, 2008



    Permanently Closed
    I160A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
    The main purpose of this study is to find out what effects an experimental drug called CCI-779 has on patients with endometrial cancer, and to find out the side effects (good or bad) the drug causes. As well, researchers will look at tumour tissue samples (from a sample of endometrial cancer that was removed at the time of the initial diagnosis) to find out what effects CCI-779 has on individual cancer cells. Patients who meet all of the eligibility criteria will be given CCI-779 by needle into a vein over 30 minutes once a week. Treatment will be repeated every 4 weeks.
    A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of CCI-779 activation. Group A patients may have had up to one prior hormonal treatment (adjuvant or metastatic) with no prior chemotherapy permitted. Group B patients may have had an unlimited number of prior hormonal treatments (adjuvant or metastatic) and must have had one cycle of cytotoxic chemotherapy.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour). To explore the relatinoship between objective tumour response with other molecular measures in diagnostic tumour tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT00072176
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 14, 2004 Closing Date: June 15, 2007



    Permanently Closed
    I149A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer
    The main purpose of this study is to find out what effects a drug called OSI-774 (experimental drug) has on patients with ovarian cancer when it is given together with a drug called carboplatin (a drug that we use in ovarian cancer now). Another purpose of this study is to find out what side effects (good or bad) the drug causes. As well, researchers will look at tumour tissue samples to find out what effects the drug has on individual cancer cells.
    A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer

    Eligibility: Patients with histologically documented epithelial ovarian cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Up to 2 prior chemotherapy regimens with the first regimen containing carboplatin or cisplatin. Patients MUST have responded to platinum based first-line chemotherapy. No prior EGFR targeting therapy permitted.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced ovarian carcinoma who are reveiving carboplatin. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR status from primary tumour in these patients. To explore patterns of change in EGFR markers in patients that have biopsies and/or ascitic taps (additional investigations). To assess CA 125 response in patients with elevated CA 125 levels at study entry.

    NCT Registration ID (from clinicaltrials.gov): NCT00030446
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2002 Closing Date: June 01, 2004



    Permanently Closed
    I148A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium
    The main purpose of this study is to find out what effects an experimental drug called OSI-774 has on patients with endometrial cancer, and to find out the side effects (good or bad) the drug causes. As well, researchers will look at tumour tissue samples to find out what effects the drug has on individual cancer cells.
    A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium

    Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Patients may have had up to one prior hormonal treatment (adjuvant or metastatic). No prior chemotherapy permitted. No prior EGFR targetting therapy permitted.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced/metastatic carcinoma of the endometrium. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR expression from primary tumour in these patients. To explore patterns of change in markers of EGFR activation in patients that have biopsies (additional investigations).

    NCT Registration ID (from clinicaltrials.gov): NCT00030485
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2002 Closing Date: March 16, 2004



    Permanently Closed
    I138NCIC CTG Randomized Phase II Study of NX211 Given by Two Different Intravenous Schedules in Advanced and/or Recurrent Epithelial Ovarian Cancer

    NCIC CTG Randomized Phase II Study of NX211 Given by Two Different Intravenous Schedules in Advanced and/or Recurrent Epithelial Ovarian Cancer

    Eligibility: Histologically documented advanced and/or recurrent epithelial ovarian cancer (primary fallopian or peritoneal cancer also eligible). One or two prior regimens of chemotherapy required with at least one regimen containing cisplatin or carboplatin. At least one site unidimensional disease.

    Objectives: To evaluate, in parallel, the efficacy of two treatment schedules of NX211 as determined by objective response and tumour marker (CA125) in patients with advanced and/or recurrent ovarian cancer. To evaluate the safety, time to progression, and pharmacokinetics of both treatment schedules.

    NCT Registration ID (from clinicaltrials.gov): NCT00010179
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 31, 2000 Closing Date: September 21, 2001



    Permanently Closed
    I116NCIC CTG Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

    NCIC CTG Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003892
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 01, 1999 Closing Date: May 05, 2000



    Permanently Closed
    I126A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer

    A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00004251
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 19, 2000 Closing Date: May 16, 2001



    Permanently Closed
    I106BPhase II Study of Topotecan/Cisplatin Followed by Paclitaxel/Carboplatin as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

    Phase II Study of Topotecan/Cisplatin Followed by Paclitaxel/Carboplatin as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 27, 1999 Closing Date: December 16, 1999



    Permanently Closed
    I59NCIC CTG Phase I Study of IL-3 in Patients With Relapsed Ovarian Cancer Receiving Carboplatin

    NCIC CTG Phase I Study of IL-3 in Patients With Relapsed Ovarian Cancer Receiving Carboplatin

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 10, 1990 Closing Date: March 27, 1992



    Permanently Closed
    I82NCIC CTG Randomized Phase II Study of Topotecan in Previously Treated Patients With Ovarian Cancer

    NCIC CTG Randomized Phase II Study of Topotecan in Previously Treated Patients With Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 08, 1994 Closing Date: April 22, 1997



    Permanently Closed
    I74NCIC CTG Phase I Study of Biweekly Taxol/Cisplatin as Initial Chemotherapy for Ovarian Cancer

    NCIC CTG Phase I Study of Biweekly Taxol/Cisplatin as Initial Chemotherapy for Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 02, 1992 Closing Date: October 07, 1994



    Permanently Closed
    I199A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.
    The main purpose of this study is to find out how effective the experimental drug temsirolimus is in treating cervical cancer. In addition, this study will look at the side effects of temsirolimus when given IV weekly. Additional research will investigate tissue samples from previously removed cervical lesions.
    A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.

    Complexity Level: 2

    Eligibility: Patients with histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix, or adenocarcinoma of the cervix. Clinically and/or radiologically documented disease. Only one prior chemotherapy regimen allowed. Patient must be > 4 weeks since chemotherapy, radiation therapy and surgery. No prior treatment with an mTOR inhibitor. Patient must have tumour tissue from their primary tumour available.

    Objectives: 1.1 To assess the efficacy (objective response rate) of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.2 To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.3 To explore the relationship between expression of proteins in the mTOR pathway in archival tissue samples from patients on this trial and their objective response to therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT01026792
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 17, 2009 Closing Date: October 27, 2011



    Permanently Closed
    I192A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer
    The main purpose of this study is to find out how effective the experimental drug ridaforolimus is in treating endometrial cancer. In addition, this study will look at the side effects of ridaforolimus. Treatment will be ridaforolimus once daily by mouth for 5 days a week. Treatment will continue as long as the cancer does not get worse and the side affects are not too severe and the patient wishes to continue.
    A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of deforolimus activation. Prior hormonal treatment (adjuvant or metastatic), but no prior chemotherapy permitted.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of ridaforolimus given orally, once daily, 5 days/week continuously in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of ridaforolimus in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour).

    NCT Registration ID (from clinicaltrials.gov): NCT00770185
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 26, 2008 Closing Date: August 11, 2010



    Permanently Closed
    I157 (PHL002)A Phase I/II Study of OSI-774 in Combination With Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (Princess Margaret Hospital Phase II Consortium - PHL 002)

    A Phase I/II Study of OSI-774 in Combination With Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (Princess Margaret Hospital Phase II Consortium - PHL 002)

    Eligibility: Recurrent, unresectable and/or metastatic squamous cell cancer of the head and neck; no prior chemotherapy for recurrent/metastatic disease; unidimensionally measurable disease; patients must have completed any prior radiotherapy > 4 weeks before study entry

    Objectives: To determine the objective response rate of OSI-774 in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck.

    NCT Registration ID (from clinicaltrials.gov): NCT00030576
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2003 Closing Date: September 22, 2004



    Permanently Closed
    I105NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer

    NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 1997 Closing Date: February 22, 1999



    Permanently Closed
    I216Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia
    The main purpose of this study is to determine the overall response rate and evaluate the safety and tolerability of buparlisib and explore potential molecular factors which may be prognostic or predictive of response or of relapse in patients with relapsed and refractory chronic lymphocytic leukemia.
    Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia

    Complexity Level: 2

    Eligibility: Patients with previously documented CLL that is recurrent or relapsed after previous therapy and that requires treatment. Patient must have at least one of the following: lymphocyte count >or= 10 x 10/9/L OR at least one pathologically enlarged lymph node (>or= 2 x 2 cm) by CT scan. Patients must have received at least 1 prior systemic treatment regimen (single agent or combination therapy) and recovered from all reversible toxicity related to prior chemotherapy and have adequate washout period. ECOG 0-2. At least 14 days since major surgery and 21 days since prior radiation therapy.

    Objectives: To determine the overall response rate (complete + partial response). To evaluate the safety and tolerability of buparlisib. To evaluate additional measures of efficacy including duration of response rate and progression free survival. To explore potential molecular factors which may be prognostic or predictive of response or of relapse including: correlation between clinical response and MTT assay in B-CLL exposed ex-vivo to buparlisib; correlation between response to buparlisib and western blot and flow cytometry analysis of key proteins involved in the PI3K pathway; identification of mechanisms of resistance among patients who relapse after therapy with buparlisib; to prospectively validate a survival prediction scale.

    NCT Registration ID (from clinicaltrials.gov): NCT02340780
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: January 30, 2015 Closing Date: January 24, 2017



    Closed to Accrual
    I100NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML

    NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 09, 1996 Closing Date: May 13, 1998



    Permanently Closed
    I108A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma

    A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 05, 1997 Closing Date: May 07, 1998



    Permanently Closed
    I172Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.
    A phase II study for patients with mantle cell lymphoma who have received one or two prior chemotherapy regimens. Patients will receive bortezomib (PS-341, Velcade) and gemcitabine in 3 week cycles as long as their disease does not get worse, they do not have serious side effects and they wish to continue.
    Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.

    Eligibility: Histologically documented mantle cell lymphoma non-refractory to prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. 1-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior PS-341/bortezomib or other investigational therapy (excluding flavopiridol). Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Adequate organ function; no pre-existing edema, neuropathy or dyspnea >= gr 2 or ascites or pleural effusions. No serious cardiovascular disease and adequate cardiac function - LVEF >= 45%.

    Objectives: To determine the efficacy (response rate) of bortezomib given as a bolus intravenous injection twice weekly for 2 out of 3 weeks in combination with gemcitabine given as a 30 min. intravenous infusion once weekly for two consecutive weeks in patients with relapsed mantle cell lymphoma. To assess the toxicity of this combination as well as time to progression and response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00377052
    Participation: Limited to selected centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 14, 2006 Closing Date: September 19, 2008



    Permanently Closed
    I194A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma
    The main purpose of this study is to find out how effective the study drug AT7519M is in treating mantle cell lymphoma. Treatment will be given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed MCL. Patients will be those who meet all of the eligibility criteria. Treatment will be repeated every 3 weeks (1 cycle = 3 weeks) and will continue for up to 4 cycles as long as the cancer does not progress and the side effects are not too severe and the patient wishes to. If patients achieve a response to treatment, they may be on the study until the cancer worsens or for 2 more cycles after they show a response.
    A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma

    Complexity Level: 2

    Eligibility: Patients with documented mantle cell lymphoma non-refractory to prior therapy. Patients must have received at least one and up to 3 prior systemic treatment regimens. Patients must have at least one site of bidimensional disease to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

    Objectives: Primary: To assess the efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed mantle cell lymphoma (MCL). Secondary: - To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed mantle cell lymphoma. - To explore potential proteomic and metabolic serum markers of clinical response to AT7519M in MCL by assessment of peripheral blood collected at baseline and on study.

    NCT Registration ID (from clinicaltrials.gov): NCT01652144
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 24, 2012 Closing Date: May 07, 2014



    Permanently Closed
    I16NCIC CTG Phase II Study of Acivicin in Lymphoma

    NCIC CTG Phase II Study of Acivicin in Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 12, 1984 Closing Date: October 30, 1987



    Permanently Closed
    I20NCIC CTG Phase II Study of Menogaril in Lymphoma

    NCIC CTG Phase II Study of Menogaril in Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 30, 1985 Closing Date: November 14, 1988



    Permanently Closed
    I62NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma

    NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 07, 1991 Closing Date: February 17, 1993



    Permanently Closed
    I193A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.
    The main purpose of this study is to find out how effective the study drug AT7519M is in treating chronic lymphocytic leukemia. Treatment will be given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed/refractory CLL. Patients will be those who meet all of the eligibility criteria. Treatment will be repeated every 3 weeks (1 cycle = 3 weeks) and will continue for up to 4 cycles as long as the cancer does not progress and the side effects are not too severe and the patient wishes to. If patients achieve a response to treatment, they may be on the study until the cancer worsens or for 2 more cycles after they show a response
    A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.

    Complexity Level: 2

    Eligibility: Patients with documented chronic lymphocytic leukemia with at least one and up to 3 prior systemic treatment regimens. Patients must have either lymphocyte count >= 10 x 109/L or at least one measurable lymph node >= 2 cm x 2 cm to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

    Objectives: To assess the efficacy of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia. To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed/refractory CLL. To demonstrate the pharmacodynamic activity of AT7519M in patients with relapsed and/or refractory CLL by establishing its effects on relevant biological endpoints (markers of CDK inhibition, apoptotic markers and cell cycle suppressors) in circulating lymphocytes. To investigate the relationship between baseline cytogenetics and other molecular markers in response to AT7519M.

    NCT Registration ID (from clinicaltrials.gov): NCT01627054
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2012 Closing Date: November 22, 2013



    Permanently Closed
    I22NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell

    NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 26, 1985 Closing Date: July 15, 1986



    Permanently Closed
    I3NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma

    NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 09, 1983 Closing Date: May 14, 1984



    Permanently Closed
    I145A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma

    A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma

    Eligibility: Patients with confirmed diagnosis of multiple myeloma with a measurable serum or urine M-component at initial diagnosis. Patients must have relapsed following first or second line oral alkylating therapy or high dose chemotherapy and stem cell transplant. Patients are not eligible if they relapsed during prior treatment, have had > 2 prior chemotherapy regimens or relapsed within 3 months after last treatment.

    Objectives: To assess the efficacy of ZD6474 when given orally to patients with relapsed previously treated multiple myeloma. To determine the toxic effects, duration of response, time to progression, and pharmacokinetics profile and characteristics, as well as to examine bone marrow samples in patients with multiple myeloma given ZD6474.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 02, 2002 Closing Date: April 08, 2004



    Permanently Closed
    I150A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
    The purpose of this study is to find out what effects the investigational agent PS-341 has on patients with mantle cell lymphoma. This research is being done to find out if PS-341 will cause the cancer to shrink.
    A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

    Eligibility: Histologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or no prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. O-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior investigational therapy. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

    Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To determine 20S proteasome levels in whole blood and correlate suppression of this marker with toxicity and response to PS-341.

    NCT Registration ID (from clinicaltrials.gov): NCT00030875
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 2002 Closing Date: July 28, 2004



    Permanently Closed
    I127A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

    Eligibility: Histologically or cytologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or with no prior therapy. Pathology must be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility BEFORE patient registration if questionable. Presence of clinically and/or radiologically documented disease. 0-2 prior chemotherapy regimens permitted. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

    Objectives: To assess the efficacy of flavopiridol, given as a 3 day bolus every 21 days. To assess the toxicity of flavopiridol when administered on this schedule in the patient group.

    NCT Registration ID (from clinicaltrials.gov): NCT00005074
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 24, 2000 Closing Date: October 10, 2001



    Permanently Closed
    I84NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia

    NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 07, 1994 Closing Date: November 23, 1995



    Permanently Closed
    I78NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma

    NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 01, 1993 Closing Date: October 25, 1994



    Permanently Closed
    I191A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma
    The main purpose of this study is to find out whether the new drug AT9283 will slow the growth of multiple myeloma. A secondary objective is to learn more about the side effects of AT9283.
    A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma

    Complexity Level: 2

    Eligibility: Patients must have a confirmed diagnosis of multiple myeloma and measurable disease, according to internationally accepted criteria for myeloma. Patients must have received prior treatment for multiple myeloma, and have relapsed or progressed on prior therapy. No more than three prior regimens; prior treatment must be completed at least 4 weeks prior to registration. ECOG performance status must be 0, 1 or 2; adequate hematologic and organ function.

    Objectives: To assess the efficacy of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks to patients with relapsed or refractory multiple myeloma; to determine the adverse effects of AT9283; to evaluate potential predictive and prognostic biomarkers (marrow, blood); and to evaluate disease-related symptoms including pain, fatigue and mucositis.

    NCT Registration ID (from clinicaltrials.gov): NCT01145989
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 2010 Closing Date: July 26, 2012



    Permanently Closed
    I186A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS
    The main purpose of this study is to find out what doses of the experimental drug Sorafenib can be used in combination with Ara-C (cytarabine) and how effective this combination is in treating leukemia or another blood disorder called high-risk myelodysplastic syndrome. Patients will be those who are > 60 years and who meet all of the eligibility criteria. Treatment will be Ara-C twice daily by subcutaneous injection days 1 - 10 and sorafenib twice daily orally from days 2 - 28. Treatment will be repeated every 4 weeks (1 cycle = 4 weeks) and will continue as long as the cancer does not progress and the side effects are not too severe and the patient wishes to. If patients achieve a response to treatment, therapy will continue for 2 cycles after response criteria are met.
    A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS

    Complexity Level: 1

    Eligibility: Patients age > 60 years and not suitable for intensive chemotherapy regimens with pathologically confirmed AML or high-risk MDS. o ECOG performance status 0, 1, or 2 o Prior Chemotherapy: None except hydroxyurea permitted provided discontinued > 48 hours prior to start of protocol therapy o Biochemistry: bilirubin and creatinine within normal limits, AST/ALT < 2 x UNL o No documented CNS involvement o No serious medical condition including: significant neurologic or psychiatric disorder, active uncontrolled infection

    Objectives: Phase I Portion: To determine the recommended dose of sorafenib and Ara-C given in combination in elderly patients with AML or high-risk MDS who are not suitable for intensive chemotherapy. To determine the safety, tolerability, toxicity profile and dose limiting toxicities of the combination sorafenib and Ara-C in this patient population. Phase II Portion: To estimate the efficacy (as measured by complete response rate) of the recommended dose of sorafenib given orally in combination with Ara-C in elderly patients with AML or high-risk MDS. To describe the toxic effects and overall response rate (complete plus partial) in this population. To evaluate potential correlates of response in translational research studies including FLT-3 ITD's and point mutations in blasts.

    NCT Registration ID (from clinicaltrials.gov): NCT00516828
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 24, 2007 Closing Date: December 10, 2009



    Permanently Closed
    I182A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma
    A phase II study for patients with diffuse or thymic (mediastinal)large B-cell lymphoma who have received one regimen which included doxorubicin but the lymphoma either didn't respond or has come back. Patients may have also received treatment with one other non-chemotherapy regimen. Patients will receive sunitinib (SU11248) orally every day. One cycle equals 4 weeks and a patient may continue for up to 12 cycles (1 year) as long as their disease does not get worse, they do not have serious side effects and they wish to continue.
    A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

    Eligibility: - Histologically documented diffuse large B-cell or mediastinal (thymic) large B-cell lymphoma, advanced or metastatic disease. - Patients must have received at least one, and up to two prior chemotherapy regimens, one of which must have been doxorubicin-based. - Patients may be relapsed post stem cell transplant as the preparative regimen and high dose chemotherapy will be considered as one regimen. Patients may have received one other non-chemotherapy regimen in the form of radiation. - No prior therapy with angiogenesis inhibitors or multi-targeted tyrosine kinase inhibitors - > 28 days since prior chemotherapy, hormonal therapy, radiation therapy or major surgery - Bidimensionally measurable disease; no known brain metastases - ECOG performance status: 0 or 1 - No serious medical conditions or cardiac disease (as specified in protocol); no uncontrolled hypertension

    Objectives: 1. To assess the efficacy (response rate) of sunitinib given orally daily in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 2. To assess the toxicity of sunitinib in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 3. To assess the effects of sunitinib on the peripheral blood biomarkers circulating endothelial cells (CECs) and their precursors (CEPs) in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00392496
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 08, 2006 Closing Date: March 24, 2009



    Permanently Closed
    I152 (IND.152)A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia

    A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia

    Eligibility: Confirmed diagnosis of Waldenstrom's Macroglobulinemia. If newly diagnosed or untreated must have IgM > 20 g/L, if previously treated IgM must be > 5g/L at time of registration. Must be symptomatic. O-2 prior chemotherapy regimens, non-refractory to prior therapy; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

    Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray.

    NCT Registration ID (from clinicaltrials.gov): NCT00045695
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 27, 2002 Closing Date: March 23, 2005



    Permanently Closed
    I141A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

    A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

    Eligibility: Acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), not requiring urgent cytoreductive therapy. One prior chemotherapy regimen permitted.

    Objectives: To determine the maximum tolerated doses (MTD) and the recommended doses (RD) of two different schedules of BAY 43-9006 in patients with AML or MDS. To determine toxic effects, pharmacokinetics, gene expression, target effects and clinical response rates of BAY-43-9006 in this patient population.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 01, 2001 Closing Date: April 01, 2004



    Permanently Closed
    I227A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma
    This is an international, multicentre randomized 2 arm trial that compares immunotherapy alone vs immunotherapy plus chemotherapy.
    A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma

    Complexity Level: 1

    Eligibility: Patients must have histologically confirmed unresectable advanced and/or metastatic malignant pleural mesothelioma with available tumour block. No prior chemotherapy for advanced/metastatic disease. Prior (neo) adjuvant cisplatin-based systemic chemotherapy allowed if last dose > 12 months before registration. No prior targeted small molecule therapy, immunotherapies and viral therapies, biologic therapies and angiogenesis inhibitors for advanced/metastatic disease, or any prior immunotherapy for any stage of disease. Prior radiation therapy is permitted (< 30% BM), measurable disease outside the previously irradiated area is required. No diagnosis of immunodeficiency or is receiving systemic steroid therapy (doses > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. No active autoimmune disease requiring systemic treatment < 3 years. No live attenuated vaccines within 30 days.

    Objectives: rimary - To evaluate whether pembrolizumab, alone or given to patients receiving standard chemotherapy, improves progression free survival in malignant pleural mesothelioma (MPM) compared to standard chemotherapy. Secondary To evaluate whether pembrolizumab improves overall survival when added to standard chemotherapy; To evaluate the tolerability of pembrolizumab, alone or given to patients receiving standard chemotherapy; To assess antitumour activity of pembrolizumab, alone or given to patients receiving standard chemotherapy including response rate and overall survival; To evaluate quality of life effects of pembrolizumab, alone or given to patients receiving standard chemotherapy. Exploratory - To explore the predictive and prognostic value of PD-L1 expression and presence of T cell subsets within the tumour microenvironment and other exploratory blood based biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT02784171
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 07, 2016



    Open to Accrual
    I219A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer

    A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically and/or cytologically confirmed stage IIIB/IV non-squamous, KRAS wildtype or unknown, NSCLC that is metastatic or unresectable and for which standard curative measures do not exist. All patients must have formalin fixed paraffin embedded tissue block available for correlative studies. Must have at least one site of disease that is unidimensionally measurable. ECOG 0-1. No prior MEK inhibitors or tyrosine kinase inhibitor (including EGFR inhibitors of any kind). Prior adjuvant platinum-based chemotherapy or combined chemoradiation with curative intent is permissible if completed > 1 yr prior to enrolment. No prior cytotoxic chemotherapy for advanced/metastatic disease. No significant cardiac disease or gastrointestinal disease. No untreated brain or meningeal metastases (untreated or treated). No potent inhibitors/inducers of CYP3A4/5,CYP2C19/CYP1A2. No central serous retinopathy, retinal vein occlusion, high intraocular pressure or uncontrolled glaucoma.

    Objectives: Primary Objective: To determine the efficacy, as determined by objective response rate, of selumetinib (intermittent or continuous) in patients with NSCLC not known to have KRAS mutation receiving standard pemetrexed and cisplatin chemotherapy compared to chemotherapy alone. Secondary Objectives: To assess the tolerability of selumetinib in patients receiving pemetrexed and cisplatin, to explore the progression free survival of patients receiving selumetinib with pemetrexed and cisplatin to those receiving pemetrexed and cisplatin or carboplatin alone and to explore whether KRAS mutation, other common mutations, or tumour based molecular signatures are predictive of selumetinib effect.

    NCT Registration ID (from clinicaltrials.gov): NCT02337530
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: February 05, 2015 Closing Date: May 08, 2017



    Closed to Accrual
    I110NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer

    NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 1998 Closing Date: June 07, 1999



    Permanently Closed
    I42NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer

    NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 23, 1987 Closing Date: April 25, 1988



    Permanently Closed
    I2LNCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer

    NCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 03, 1981 Closing Date: March 09, 1984



    Permanently Closed
    I65NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer

    NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1992 Closing Date: December 04, 1992



    Permanently Closed
    I33NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer

    NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 29, 1986 Closing Date: July 31, 1987



    Permanently Closed
    I89NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer

    NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 12, 1995 Closing Date: February 04, 1997



    Permanently Closed
    I79NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer

    NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 13, 1993 Closing Date: February 08, 1996



    Permanently Closed
    I215A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.
    The main purpose of this study is to determine the recommended phase II dose and safety profile of selumetinib in patients with advanced/metastatic NSCLC, to obtain pharmacokinetic profiles of selumetinib in combination with chemotherapy, to explore gene expression signatures/profiles and/or KRAS codon subtypes in tumour and/or tumour derived material.
    A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.

    Complexity Level: 1

    Eligibility: Patients with histologic and/or cytologic confirmed non-small cell lung cancer that is metastatic or unresectable and for which standard curative measures do not exist. Patients accrued to the pemetrexed single agent cohort as well as those accrued to the RP2D expansion cohorts must have documented KRAS mutation, as well as at least one site of disease which is unidimensionally measurable. Patient must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour). At least 14 days since major surgery, 4 weeks since radiation therapy. ECOG 0-1. Age > 18 years. No prior MEK inhibitors or any other tyrosine kinase inhibitor.

    Objectives: Primary Objective: To determine the recommended phase II dose (RP2D) and safety profile of selumetinib in patients with advanced/metastatic NSCLC in combination with: pemetrexed; pemetrexed and cisplatin; paclitaxel and carboplatin. Secondary Objectives: 1) to obtain pharmacokinetic (PK) profiles of selumetinib when given daily continuously in combination with chemotherapy; 2) to explore gene expression signatures/profiles and/or KRAS codon subtypes in tumour and/or tumour derived material that may influence response; the use of plasma as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status; and serum exploratory markers that may predict response to selumetinib; 3) preliminary assessment of efficacy in all patients and in an expansion cohort of up to 10 patients with KRAS positive NSCLC.

    NCT Registration ID (from clinicaltrials.gov): NCT01783197
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 30, 2013 Closing Date: October 16, 2015



    Permanently Closed
    I211A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

    A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

    Complexity Level: 2

    Eligibility: Patients with a histological or cytological diagnosis of non small cell lung cancer, that is advanced and/or metastatic, for which systemic treatment with docetaxel or pemetrexed is indicated. Tumour block available. Patients must have measureable disease as defined by RECIST 1.1. Must have received one prior regimen of pallative first line chemotherapy (must be platinum containing combination unless patient >70 years), which may not have contained docetaxel. Patients who have had concurrent platinum based chemoradiotherapy for stage 3 disease and have relapsed within 1 year of treatment may be considered to have had one prior platinum containing regimen. Prior pemetrexed first line but not maintenance therapy is permissible and prior adjuvant chemotherapy is permitted if completed at least one year prior to relapse/recurrance. ECOG 0 or 1. No neuropathy >=2.

    Objectives: Primary Objective: To evaluate the effect of reolysin in combination with either docetaxel or pemetrexed on the progression free survival of patients with advanced or metastatic non small cell lung cancer. Secondary Objectives: a) To determine the tolerability and toxicity of reolysin and docetaxel or pemetrexed when given in combination. b) To investigate additional potential measures of efficacy including: progression at 3 months, objective response rate and overall survival. c) To explore potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples, including KRAS and EGFR status.

    NCT Registration ID (from clinicaltrials.gov): NCT01708993
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 15, 2012 Closing Date: August 06, 2015



    Permanently Closed
    I207A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma
    The main purpose of this study is to find out how effective the experimental drug PF-03446962 is in treating patients with pleural mesothelioma who have been previously treated with cytotoxic therapy. In addition, this study will look at the side effects of PF-03446962, the duration of response or stable disease, stable disease rate, progression-free, median and overall survival rates. Additional research will investigate tissue and blood samples for correlative science evaluation.
    A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma

    Complexity Level: 2

    Eligibility: histologically or cytologically confirmed malignant pleural mesothelioma; advanced and/or metastatic disease; at least one site of disease must be unidimensionally measurable; patients are eligible after first line cytotoxic chemotherapy has failed; patients must have received one, but no more than one, combination chemotherapy regimen for advanced disease, which must have contained platinum based chemotherapy

    Objectives: To assess the efficacy of PF-03446962 given by IV day 1 of a 2 week cycle in patients with advanced malignant pleural mesothelioma; to assess the toxicity, safety and tolerability of PF-03446962; to assess the duration of response or stable disease, stable disease rate, progression free, median and overall survival rates; to collect tissue and blood for banking and correlative science evaluation.

    NCT Registration ID (from clinicaltrials.gov): NCT01486368
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: November 30, 2011 Closing Date: January 09, 2014



    Permanently Closed
    I196A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)

    A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)

    Complexity Level: 1

    Eligibility: Patients with locally advanced or metastatic non-small cell lung cancer who have failed at least one prior chemotherapy regimen for advanced or metastatic disease. No more than 2 prior chemotherapy regimens for advanced or metastatic disease. EGFR status positive or unknown. Unidimensionally measurable disease. Archival tissue or fresh biopsy/FNA required at study entry.

    Objectives: To determine the safety, tolerability, toxicity profile, dose limiting toxicities, pharmacokinetic profile and the recommended phase II dose of Foretinib in combination with standard erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown. To assess the anti-tumour activity of Foretinib in combination with erlotinib as evidenced by response rates, clinical benefit (complete or partial response or stable disease > 8 weeks duration), survival and an exploratory endpoint of early assessment of tumour size as a continuous variable, when compared to erlotinib alone. To correlate response with various biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT01068587
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 17, 2009 Closing Date: January 24, 2013



    Permanently Closed
    I114NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer

    NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 05, 1999 Closing Date: October 20, 2000



    Permanently Closed
    I81NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer

    NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 16, 1994 Closing Date: June 14, 1995



    Permanently Closed
    I7NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma

    NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 12, 1983 Closing Date: February 15, 1985



    Permanently Closed
    I80NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer

    NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 14, 1994 Closing Date: June 14, 1996



    Permanently Closed
    I30NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma

    NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 09, 1986 Closing Date: April 01, 1987



    Permanently Closed
    I47NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer

    NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 25, 1989 Closing Date: November 30, 1990



    Permanently Closed
    I57NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer

    NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1991 Closing Date: April 02, 1992



    Permanently Closed
    I52NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer

    NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 06, 1989 Closing Date: September 19, 1990



    Permanently Closed
    I11NCIC CTG Phase II Study of TCAR in Lung

    NCIC CTG Phase II Study of TCAR in Lung

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1985 Closing Date: March 01, 1987



    Permanently Closed
    I66Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer

    Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 1992 Closing Date: May 28, 1993



    Permanently Closed
    I50NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer

    NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 04, 1991 Closing Date: September 29, 1992



    Permanently Closed
    I69NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer

    NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 08, 1993 Closing Date: October 18, 1993



    Permanently Closed
    I17NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer

    NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1985 Closing Date: April 25, 1988



    Permanently Closed
    I31NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer

    NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 18, 1985 Closing Date: October 09, 1986



    Permanently Closed
    I190A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.
    The main purpose of the phase I portion of the study is to find out which dose of MK-0646 is safe to give with standard cisplatin/etopside to patients with extensive stage small cell lung cancer. In the phase II portion, researchers will also look at what effect it has on small cell lung cancer by seeing if it makes the lesions shrink and if it changes the tumour markers. Additional research will investigate tissue samples from previously removed small cell lung cancer tumour.
    A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.

    Eligibility: Patients with histologically confirmed, extensive stage small cell lung cancer. No prior chemotherapy for SCLC. Prior radiation permitted to brain but not to lung. No uncontrolled diabetes or cardiac conditions and acceptable end-organ function. ECOG 0, 1 or 2. Unidimensionally measurable disease.

    Objectives: 1.1 Phase I Objectives 1.1.1 To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin (EP) chemotherapy regimen. 1.1.2 Evaluate the toxicity and preliminary efficacy of the combination. 1.2 Phase II Objectives 1.2.1 To assess the efficacy, as determined by objective response rate; including complete response rate, progression-free survival and overall survival. 1.2.2 To assess the toxicity and tolerability. 1.2.3 Explore the predictive and prognostic impact of biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT00869752
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 30, 2009 Closing Date: March 10, 2011



    Permanently Closed
    I183A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma
    The main purpose of this study is to find out what effects an experimental drug called Sunitinib has on patients with advanced malignant pleural mesothelioma, and to find out the side effects (good or bad) the drug causes. Patients who meet all of the eligibility criteria will take sunitinib orally daily for 4 weeks with a two week break. Treatment will be repeated every 6 weeks.
    A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma

    Eligibility: Patients with histological or cytological documented malignant pleural mesothelioma (advanced or metastatic disease). There will be two groups: Cohort 1 - previously treated patients: minimum of one prior platinum based chemotherapy, and Cohort 2 - previously untreated patients: No prior cytotoxic therapy permitted.

    Objectives: To assess the efficacy (response rate, complete and partial) of sunitinib given orally daily for 4 out of every 6 weeks in patients with malignant pleural mesothelioma in two cohorts: in patients previously treated with cytotoxic therapy (cohort 1) and in patients who have not received previous cytotoxic therapy (cohort 2). To assess the toxicity safety and tolerability of sunitinib. To assess the duration of response or stable disease, stable disease rate, progression-free, median and overall survival rates

    NCT Registration ID (from clinicaltrials.gov): NCT00392444
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 10, 2006 Closing Date: September 10, 2010



    Permanently Closed
    I120A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer

    A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCt
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 16, 1999 Closing Date: May 30, 2000



    Permanently Closed
    I224A Phase II Study of Concurrent Dabrafenib and Trametinib with Stereotactic Radiation in the Management of Patients with BRAF Mutation-Positive Malignant Melanoma and Brain Metastases
    The main purpose of the study is to find out the intracranial objective response rate to dabrafenib and trametinib with non-surgical radiation in patients with malignant melanoma and brain metastases. Dabrafenib will be taken twice a day and trametinib once a day. Patients will begin taking study drug a minimum of 7 days and a maximum of 14 days prior to starting non-surgical radiation.
    A Phase II Study of Concurrent Dabrafenib and Trametinib with Stereotactic Radiation in the Management of Patients with BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

    Complexity Level: 2

    Eligibility: Histologically confirmed melanoma metastatic to brain and determined to be BRAF V600 mutation-positive. Presence of measurable disease (with at least one measurable CNS lesion per RECIST 1.1). Presence of 1-10 brain metastases as confirmed on a thin slice axial T1 post-gadolinium MRI sequence. Maximum diameter of a single brain lesion should be <=4 cm. All CNS metastases amenable to single fraction SRS and/or fractionated SRS. ECOG 0-1. No prior treatment with a BRAF inhibitor or MEK inhibitor. No history of malignancy with confirmed activating RAS mutation at any time. No history of HEP B or HEP C virus and no history of interstitial lung disease or active pneumonitis. No prior whole brain radiation or brainstem metastases. No contraindications to MRI and/or Gadolinium contrast or stereotactic brain radiation therapy. No history or current evidence/risk of retinal vein occlusion or central serous retinopathy.

    Objectives: Primary Objective: To determine intracranial objective response rate; Secondary objectives: extra-cranial objective response rate and overall ORR; duration of response; intracranial and overall progression free survival; overall survival and to evaluate the safety and tolerability of the regimen using CTCAE v. 4.

    NCT Registration ID (from clinicaltrials.gov): NCT02974803
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: November 23, 2016



    Open to Accrual
    I225A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker
    The main purpose of this study is to find out if tumour CT texture analysis (enhancing of images in ultra-fine detail not visible to the human eye) can predict time to progression and response more accurately. Pembrolizumab will be given by needle Day 1 every three weeks.
    A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker

    Complexity Level: 2

    Eligibility: Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery. Clinically and/or radiologically documented disease. ECOG 0-1. No prior systemic therapy for metatatic melanoma. No known history of HIV. Patients with active autoimmune disease that requires systemic steroids or immunosuppressive agents are not eligible. Patients with a history of malignancy within 5 years prior to first study drug administration are not eligible. Patients with an allergy to iodinated contrast media used for CT and patients with known history of active TB are not eligible.

    Objectives: Primary Objective: to determine if tumour texture measures derived from CT correlates with response. Secondary Objectives: to determine if tumour texture measures derived from CT correlated with time to disease progression; to assess duration of response; to assess overall response rate; to assess overall survival; to compare QALY between pembrolizumab and dacarbazine; to compare QALY between pembrolizumab and ipilimumab; toxicity using CTCAE v4.

    NCT Registration ID (from clinicaltrials.gov): NCT02740920
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: May 12, 2016 Closing Date: March 12, 2018



    Closed to Accrual
    I104NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma

    NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 05, 1997 Closing Date: October 26, 1998



    Permanently Closed
    I169A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma

    A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma

    Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study

    Objectives: To assess the efficacy and toxicity of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00095953
    Participation: Participation in this phase II study is restricted to invited centres.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 2004 Closing Date: May 01, 2006



    Permanently Closed
    I202A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma
    The main purpose of this study is to compare the effectiveness of rIL-21 given by intravenous injection daily x 5 in weeks 1, 3 and 5 every 8 weeks and dacarbazine given by intravenous injection Day 1 every 3 weeks in patients with metastatic or recurrent incurable malignant melanoma. We will also be looking at side-effects and safety of these two drugs. The main purpose of this study is to find out whether 50ug/kg/day of rIL-21 is safe to give to patients, but most importantly, to study its effectiveness and side-effects when given on 5 consecutive days weeks 1, 3 and 5. Researchers will also look at blood levels to find out how the drug is distrubuted in the blood and to study the effects on the system. Additional research will investigate tissue samples from previously removed melanoma lesions.
    A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma

    Complexity Level: 2

    Eligibility: Patients with histologically documented malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means. Unidimensionally measurable disease. Prior adjuvant immunotherapy permitted; no other prior immunotherapy or chemotherapy permitted, except for RAF and MEK-Inhibitors. Patients must be >4 weeks since major surgery or radiation therapy, and >1 month since prior adjuvant immunotherapy. Patients must have archival tumour tissue from their primary and/or metastatic tumour available for correlative study.

    Objectives: To compare efficacy of rIL-21 by IV bolus injection daily x 5 in weeks 1,3,and 5 every 8 weeka(Arm 1) & dacarbazine by IV injection Day 1 every 3 weeks(Arm 2)in previously untreated patients with metastatic or recurrent incurable malignant melanoma. The primary efficacy measure for this study is progression free survival. To compare the effect of rIL-21 and dacarbazine on response rate, duration of response, and overall survival. To determine the safety & toxicity profile of rIL-21 & dacarbazine. To characterize the effects of rIL-21 on lymphocyte sub-populations cell-count, dendritic cells sub-population cell counts, circulating miR-155 and soluble CD25 in blood before & after treatment as potential biomarkers for drug activity. To evaluate pre-existing & treatment induced immunogenicity of rIL-21 by measuring antibodies to rIL-21. To assess for pharmacogenomic markers of activity and toxicity. To assess pre-therapeutic markers for response & non-progression on archival specimens.

    NCT Registration ID (from clinicaltrials.gov): NCT01152788
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 28, 2010 Closing Date: February 29, 2012



    Permanently Closed
    I14NCIC CTG Phase II Study of N-methylformamide in Melanoma

    NCIC CTG Phase II Study of N-methylformamide in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1984 Closing Date: April 29, 1985



    Permanently Closed
    I137A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma

    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma

    Eligibility: Patients with malignant melanoma, recurrent and non-curable by surgical or other means. Prior adjuvant immunotherapy permitted. No systemic therapy for relapsed disease (ie, chemotherapy naive).

    Objectives: To determine the efficacy and toxicity of flavopiridol given as a one hour IV infusion daily x three days every three weeks in patients with recurrent/metastatic malignant melanoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00005971
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 2000 Closing Date: July 13, 2001



    Permanently Closed
    I21NCIC CTG Phase II Study of Menogaril in Melanoma

    NCIC CTG Phase II Study of Menogaril in Melanoma

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 30, 1985 Closing Date: March 15, 1986



    Permanently Closed
    I5NCIC CTG Phase II Study of Spirogermanium in Melanoma

    NCIC CTG Phase II Study of Spirogermanium in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1983 Closing Date: May 14, 1984



    Permanently Closed
    I34NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma

    NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 13, 1986 Closing Date: May 07, 1987



    Permanently Closed
    I156A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
    The purpose of this research status is to find out what effects an experimental drug, Perifosine, will have on malignant melanoma. Patients who meet all of the eligibility critera listed in the protocol will take Perifosine by mouth every day for 21 days, followed by 7 days without treatment.
    A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma

    Eligibility: Patients with histologically documented malignant melanoma, with metastatic or recurrent disease not curable by other means. Patients may have had prior adjuvant immunotherapy but must NOT have received ANY prior chemotherapy. Disease must be clinically and/or radiologically documented and at least one site of disease must be unidimensionally measurable.

    Objectives: To assess the efficacy and toxicity of Perifosine given by mouth for 3 weeks every 4 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00053781
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 16, 2003 Closing Date: April 26, 2004



    Permanently Closed
    I26NCIC CTG Phase II Study of Trimetrexate in Melanoma

    NCIC CTG Phase II Study of Trimetrexate in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: November 06, 1987



    Permanently Closed
    I87A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma

    A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 26, 1995 Closing Date: May 01, 1997



    Permanently Closed
    I56NCIC CTG Phase II Study of DuP937 in Patients With Melanoma

    NCIC CTG Phase II Study of DuP937 in Patients With Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 07, 1991 Closing Date: April 23, 1992



    Permanently Closed
    I91NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases

    NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1995 Closing Date: March 31, 1997



    Permanently Closed
    I61NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma

    NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 08, 1991 Closing Date: January 21, 1992



    Permanently Closed
    I189A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma
    The main purpose of this study is to find out whether 50ug/kg/day of rIL-21 is safe to give to patients, but most importanly, to study its effectiveness and side-effects when given on 5 consecutive days weeks 1, 3 and 5. Researchers will also look at blood levels to find out how the drug is distrubuted in the blood and to study the effects on the system. Additional research will investigate tissue samples from previously removed melanoma lesions.
    A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma

    Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study.

    Objectives: To assess the efficacy and toxicity of rIL-21 given by IV push for the first 5 days weeks 1, 3 and 5 at 50ug/kg/day in the first 6 previously untreated patients with metastatic or recurrent malignant melanoma. To characterize the pharmacokinetics of rIL-21 when dosed at 50 ?g/kg/day. To characterize the effects of rIL-21 on lymphocyte cell-count and soluble CD25 in serum as a potential biomarkers for drug activity. To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to the drug and antibody induction during treatment. To assess melanoma antigenic markers for response and non progression on archival tissue from patients enrolled on the study.

    NCT Registration ID (from clinicaltrials.gov): NCT00514085
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 10, 2007 Closing Date: August 17, 2009



    Permanently Closed
    I238A Phase II Study of Durvalumab Retreatment in Patients who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity
    The main purpose of this study is to determine the safety and toxicity of retreating patients who previously discontinued immunotherapy due to and irAE with durvalumab at the time of disease progression and to investigate response and the effect of prophylactic steroid use in prevent new or recurrent irAEs. Additional research will explore PFS and the relationship between certain biomarkers and outcomes of treatment.
    A Phase II Study of Durvalumab Retreatment in Patients who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity

    Complexity Level: 1

    Eligibility: Must live within Canada and have received durvalumab +/- tremelimumab, with or without chemotherapy/targeted therapy, on CCTG studies. Experienced G3 irAEs that required study drug discontinuation per protocol, selected G4 irAEs (i.e endocrinopathies manageable with replacement therapy, hematologic toxicity) and prolonged G1/2 irAEs where the physician or patient wanted to discontinue therapy because of poor tolerability. irAE must have resolved to >=G1 or baseline and steroid therapy completed >=28 days. Documented CR, PR or prolonged SD >=24 weeks to initial IO therapy. PD >=8 weeks after discontinuation of IO. May have received prior cytotoxic chemotherapy or other systemic therapy but not subsequent immune check point inhibitors after IO discontinuation. Ineligible if previous G4 non-hematological, non-endocrine irAE, or if required biologic agents such as infliximab, or mycophenolate motefil, had PD as best response to initial IO,or symptomatic or uncontrolled brain metastases.

    Objectives: Primary: To determine the safety and toxicity profile of rechallenging with durvalumab at the time of disease progression, in patients who previously discontinued immunotherapy due to irAE. Secondary: To determine the objective response rate (RECIST 1.1 and iRECIST); To evaluate the efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs. Tertiary: To explore PFS and iPFS on rechallenge with durvalumab after progression on initial immunotherapy; To explore blood-based and stool-based biomarkers for irAEs; PD-L1 expression.

    NCT Registration ID (from clinicaltrials.gov): NCT03847649
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    I228A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours
    This trial looks at how well patinets respond to immunotherapy alone. This trial accepts patients with 7 different types of rare cancers: Salivary carcinoma (excluding adenoid cystic carcinoma histology) ; Carcinoma of unknown primary with tumour infiltrating lymphocytes (TILs) and/or expressing PD-L1 3; Mucosal melanoma; Osteosarcoma; Undifferentiated pleomorphic sarcoma; Clear cell carcinoma of the ovary and Squamous cell carcinoma of the anal canal (SCCA), that are metastatic.
    A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours

    Complexity Level: 2

    Eligibility: Clinically and/or radiologically documented disease, with at least one measurable lesion as defined by RECIST 1.1; >=16 years of age; ECOG 0 or 1; no limit on number of prior chemo; No therapy with PD-1/PD-L1 or CTLA-4 inhibitors. No prior autoimmune or inflammatory disorders ie inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome , etc., within the past 3 years prior to the start of treatment. No history of primary immunodeficiency, allogenic organ transplant that requires therapeutic use of IO agents within 28 days. No attenuated vaccination administered within 30 days. No untreated symptomatic brain mets or in whom radiation or surgery is indicated. NO pts with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.

    Objectives: To evaluate the objective response rate of the combination of durvalumab and tremelimumab given by IV every 4 weeks in patients with rare tumours. To explore the correlation between anti-tumour activity and PD-L1 expression, presence of tumour infiltrating lymphocytes (TILs) and T cell subsets within the tumour. To explore the correlation between anti-tumour activity and genomic alterations in tumour. To assess the consistency of histopathological diagnosis of rare tumours through central review of pathology specimens. To explore the correlation between anti-tumour activity and toxicity with blood based biomarkers. To evaluate the tolerability and safety of durvalumab and tremelimumab combination. To evaluate the effect of durvalumab and tremelimumab combination including time to progression, progression free survival and response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT02879162
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 19, 2016



    Open to Accrual
    I235 (CRI-CCTG-0001)A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination with Ipilimumab for the Treatment of Patients with Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay
    A Study of Immunotherapy Treatment for Patients with Advanced Cancers
    A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination with Ipilimumab for the Treatment of Patients with Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay

    Complexity Level: 2

    Eligibility: Histologically confirmed advanced metastatic or unresectable solid tumors with POLE/POLD1 mutations. Available tissue block from primary or metastatic tumor. Measurable disease per RECIST 1.1. Received at least 1 standard cancer therapy for their tumour type and progressed on most recent regimen. Adjuvant/neoadjuvant therapy is considered a prior therapy if recurrence within 1 year. Can be treatment naiive if patient has refused standard treatment or there is no standard treatment for their cancer. No prior immunotherapy. No primary CNS tumors. No prior autoimmune or inflammatory disorders within the past 3 years. No history of primary immunodeficiency, allogeneic organ transplant that requires therapeutic use of IO agents within 14 days. No hypersensitivity to nivolumab or ipilimumab or any excipient. No active brain metastases or leptomeningeal metastases. No serious illnesses or medical conditions which would not permit the patient to be managed per protocol.

    Objectives: Primary - Objective response rate by RECIST 1.1 of nivolumab alone and of nivolumab combined with ipilimumab in randomized patients with advanced solid tumors with detectable POLE or POLD1 mutations as determined by cfDNA. Secondary - Evaluate objective response rate of nivolumab alone and nivolumab in combination with ipilimumab in all treated patients with detectable POL mutations in either blood or tissue. Evaluate duration of response. Assess safety and characterize toxicities of nivolumab combined with ipilimumab and nivolumab alone. Assess the correlation between POLE/POLD1 mutations in tumor and POLE/POLD1 mutations in blood. Evaluate response by iRECIST. Exploratory - Determine Progression Free Survival and Overall Survival. Determine correlation between POLE/POLD1 mutations occurring within or outside of the exonuclease domain and tumor mutation load by whole exome and RNA sequencing. Determine correlation between tumour mutation burden in cfDNA and tumor tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT03461952
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: August 28, 2018



    Open to Accrual
    I217 (TOPAZ)A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours.
    The main purpose of this study is to determine the recommended phase 2 dose of low-dose metronomic (LDM) topotecan when given with pazopanib in children with recurrent or refractory solid tumours excluding central nervous system (CNS) tumours, and to describe the side effects. Additional research will be done on blood samples to look at how the body reacts to the topotecan, how the drugs interact and to see if there is any relation to response to treatment.
    A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours.

    Complexity Level: 1

    Eligibility: Part 1: Patients must have recurrent or refractory solid tumours, excluding CNS tumours tumours. Part 2: Patients must have neuroblastoma or rhabdomyosarcoma. All patients must have histologic verification of malignancy, adequate bone marrow, renal, cardiac and liver function, measurable or evaluable disease and must meet all other eligibility criteria as defined in Protocol Section 4.

    Objectives: Primary Objective: To determine the recommended phase II dose and maximum tolerated dose of LDM topotecan in combination with pazopanib. Secondary Objectives: Anti-tumour activity in solid tumours and specifically in neuroblastoma and rhabdomyosarcoma. Characterize the pharmacokinetic profile as well as drug-drug interactions, and assess the anti-angiogenic activity.

    NCT Registration ID (from clinicaltrials.gov): NCT02303028
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: November 03, 2014



    On Hold
    I231A Phase I Study of CX5461
    The main purpose of this study is to determine the best dose of CX5461 in patients with solid tumours (phase I) and breast cancer with known tumour DNA abnormalities (phase II), and to investigate the safety and toxicity of CX5461, as well as response and clinical benefit of this therapy. Additional research will investigate the effects CX5461 has on cancer cells, as well as explore the relationship between certain tumour DNA abnormalities and outcomes of CX5461 treatment.
    A Phase I Study of CX5461

    Complexity Level: 1

    Eligibility: All patients: Age >=18 years. ECOG 0, 1, or 2. Must have an available tissue block. Adequate organ function. Patients must not have known photosensitivity disorders, and must agree to use adequate sun protection and avoid tanning booths. No active infections or untreated/uncontrolled cardiovascular conditions. Phase I: Patients with histologically and/or cytologically confirmed solid malignancy. No limit to the number of prior cytotoxic or other systemic therapy regimens. Phase II: Patients must have triple negative breast cancer or must have BRCA1/2 or HRD germline or somatic aberrations (known, or documented during pre-enrolment screening). Must provide consent for a whole blood sample. At least 6 patients in each cohort must provide consent for a tumour and skin biopsy prior to and on treatment. Must have received at least one but no more than 3 prior cytotoxic therapy regimens. No limit to the number of prior other systemic therapy regimens, but prior PARP inhibtors not allowed.

    Objectives: Phase I: Primary - To determine the recommended phase II dose (RP2D) and schedule of CX5461 in patients with solid tumours. Secondary - To establish the safety and tolerability of CX5461 given intravenously to patients with solid tumours; To determine the pharmacokinetics of CX5461 given intravenously in patients with solid tumours. Exploratory - To explore the relationship between germline HRD aberrations and outcomes of CX5461. Phase II: Primary - To evaluate anti-tumour activity assessed by response rate (RR) in each cohort. Secondary - To estimate the progression free survival (PFS) rate at 6 months in each cohort; To assess the safety and toxicity profile of CX5461. Exploratory - To evaluate predictive biomarkers of response to CX5461; To evaluate pharmacodynamic biomarkers of response to CX5461 using ctDNA (all patients) and paired biopsies (selected patients); To explore the relationship between germline HRD aberrations and outcomes of CX5461.

    NCT Registration ID (from clinicaltrials.gov): NCT02719977
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: May 16, 2016



    On Hold
    I206A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.

    A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.

    Complexity Level: 2

    Eligibility: Patients with recurrent, unresectable, locally advanced or metastatic rare tumours: vascular sarcomas (non-pediatric); clear cell carcinomas of ovary, endometrium; medullary thyroid carcinoma; non-pancreatic neuroendocrine tumours: pheochromocytoma, paragangliomas; adrenocortical carcinoma; thymic carcinoma; fibrolamellar hepatocellular carcinoma; rare tumours with somatic mutations in VEGFR, PDGFR, KIT, RET; rare tumours arising from known/suspected germline mutations in PTEN, TS, LKB1, NF1/2. Unidimensionally measurable disease. Archival tissue or fresh biopsy required at study entry. No limit on prior chemotherapy or radiation therapy, although no prior treatment with mTOR inhibitor (for temsirolimus) or VEGFR, PDGFR, RET or KIT inhibitor (for sunitinib) permitted. No uncontrolled hypertension, therapeutic doses of coumadin-derivative anticoagulants, or certain CYP3A4 inhibitors/inducers permitted on sunitinib arm.

    Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 weeks every 6 weeks and temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent rare tumours. To assess the adverse events, time to progression and response duration of sunitinib orally and temsirolimus given IV weekly in patients with rare tumours. To assess time to first and second progression for patients who receive sunitinib and temsirolimus in sequence. To explore the relationship between genetic alterations in the genome in archival and/or fresh tumour tissue and blood samples from patients on this trial and their objective response to therapy. To assess the consistency of diagnosis of rare tumours through central review of pathology specimens.

    NCT Registration ID (from clinicaltrials.gov): NCT01396408
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: July 14, 2011 Closing Date: February 05, 2015



    Closed to Accrual
    I214A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients with Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours
    The main purpose of this study is to determine the recommended dose/schedule of MG1MA3 when AdMA3 has been administered first as priming therapy and to determine the safety, tolerability, adverse events (side effects) and immune and anti-tumour activity. Additional research will investigate viral delivery, replication and shedding in blood, tissue, urine, stool and saliva samples taken during the study.
    A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients with Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours

    Complexity Level: 1

    Eligibility: Patients with histologically confirmed, unresectable locally advanced/metastatic solid tumour (Phase I - Esophogeal/GEJ/gastric, NSCLC and breast, fallopian tube, bladder, adenocystic, anal, melanoma, periampullary, renal, liver, vulvar and ovarian). Tumour must be MAGE-A3 positive. Patient must have have at least one additional tumour mass amenable to core or excisional biopsy and must consent and be willing to undergo at least 2 core biopsies. Patients must have had a least one prior standard first line therapy for advanced/metastatic disease with adequate wash-out period since last dose. Patients must have measurable disease per RECIST 1.1 and adequate organ function. At least 4 weeks since major surgery or radiation therapy. ECOG 0-1. Age >= 18 years.

    Objectives: Phase I-To determine the recommended phase II dose/schedule and maximum tolerated dose of MG1MA3 alone, AdMA3 alone and in combination. To determine the safety, tolerability, pharmacokinetics (PK) including viral shedding, viral delivery and replication in the tumour cells and anti-tumour activity. Phase II-To assess the anti-tumour activity as evidenced by response rates and further explore the safety profile, PK, cellular and immune response, changes in tumour biomarkers and evaluate overall survival, time to progression by tumour type.

    NCT Registration ID (from clinicaltrials.gov): NCT02285816
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: October 31, 2014 Closing Date: April 11, 2019



    Closed to Accrual
    I221A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies
    The main purpose of this study is to determine the best dose of IPH2201 in patients with high-grade serous ovarian/fallopian tube or peritoneal carcinoma (platinum sensitive or platinum resistant), and to investigate the safety and toxicity of IPH2201. Additional research will investigate how IPH2201 is absorbed, how long IPH2201 stays in the body, and what effects IPH2201 is having on the cancer cells.
    A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies

    Complexity Level: 1

    Eligibility: Patients with histologically and/or cytologically confirmed high-grade serous ovarian/fallopian tube or peritoneal carcinoma. Patients must have received prior cytotoxic chemotherapy (at least one regimen must have been platinum-containing) and may be either platinum sensitive or platinum resistant. Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. For Part 2, must be willing to undergo a tumour biopsy prior to registration. Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active immune-mediated diseases including known HIV infection or hepatitis B/C. No systemic corticosteroid therapy at doses higher than 5 mg/day.

    Objectives: PRIMARY - To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin. SECONDARY - (1) To characterize the pharmacokinetics of IPH2201 when administered as a single agent; (2) To assess the pharmacodynamic effects of single agent IPH2201; (3) To assess the safety and toxicity profile of single agent IPH2201; (4) To explore the efficacy of IPH2201 in platinum resistant or sensitive HGSC; (5) To characterize the immunogenicity of IPH2201 when administered as a single agent.

    NCT Registration ID (from clinicaltrials.gov): NCT02459301
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: August 24, 2015 Closing Date: April 20, 2017



    Closed to Accrual
    I226A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given with or without Standard Chemotherapy Regimens

    A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given with or without Standard Chemotherapy Regimens

    Complexity Level: 1

    NCT Registration ID (from clinicaltrials.gov): NCT02537418
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: October 01, 2015 Closing Date: September 06, 2017



    Closed to Accrual
    I101NCIC CTG Phase I Dose Finding Study of RPR 109881A Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumours

    NCIC CTG Phase I Dose Finding Study of RPR 109881A Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumours

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 23, 1996 Closing Date: March 13, 1998



    Permanently Closed
    I122A Phase I Study of Oral ZD1839 Given Daily in Patients With Solid Tumours

    A Phase I Study of Oral ZD1839 Given Daily in Patients With Solid Tumours

    Eligibility: Advanced and/or metastatic solid tumours, expected to have epidermal growth factor receptor (EGFR) mutation/over-expression and tissue accessible for needle biopsy. Prior chemotherapy permissible.

    Objectives: To determine the biologically active dose range (BADR) as evidence of target effect in a number of clinical correlative studies and MTD (if BADR is not defined prior to MTD) of oral ZD1839 when given daily. To determine safety/toxicity profile, dose limiting toxicities and pharmacokinetics of oral ZD1839.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 14, 1999 Closing Date: June 28, 2001



    Permanently Closed
    I124A Phase I Study of MG98 Given as a 21 Day Continuous IV Infusion in Patients With Advanced Cancer

    A Phase I Study of MG98 Given as a 21 Day Continuous IV Infusion in Patients With Advanced Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 11, 1999 Closing Date: May 12, 2000



    Permanently Closed
    I130A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer
    The purpose of this study is to find out how much T900607 can be given safely to people with cancer without causing side effects that are too severe. Patients are given T900607 and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of T900607. Patients joining the study later on will get higher doses of T900607 than patients who join earlier. This will continue until a dose is found that causes temporary but severe side effects.
    A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer

    Eligibility: Patients with advanced refractory cancer. Unidimensionally measurable disease. Prior chemotherapy radiation (< 25 % hematopoietic bone marrow), immunotherapy and surgery permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of T900607 when given as a 60 minute infusion every 21 days. To evaluate the safety and dose-limiting toxicities (DLT), determine the pharmacokinetics parameters and pharmacodynamic effects. Document preliminary efficacy information and correlate expression of drug resistance markers with response.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 07, 2000 Closing Date: December 19, 2002



    Permanently Closed
    I133A Phase I Study of NX211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients With Solid Tumours

    A Phase I Study of NX211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients With Solid Tumours

    Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours with 1 or less prior chemotherapy regimens.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of NX211 given in combination with cisplatin on days 1, 2 and 3 every 3 weeks. To describe the toxicity profile, dose limiting toxicities and the pharmacokinetics of NX211 and cisplatin when given in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. Objective tumour response will be assessed in those patients with measurable disease in particular for the patients with small cell lung cancer entered at the level of MTD.

    NCT Registration ID (from clinicaltrials.gov): NCT00006036
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 22, 2000 Closing Date: November 22, 2001



    Permanently Closed
    I134A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks
    The purpose of this study is to find out how much BAY 38-3441 can be safely given to patients with cancer. Patients are given BAY 38-3441 and are watched very closely to see what side effects they have. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of BAY 38-3441. This will continue until we find the highest dose of BAY 38-3441 which can be safely given to patients.
    A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks

    Eligibility: Histologically documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended dose of BAY38-3441 when given as a short daily infusion for five days every three weeks to patients with advanced cancer.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 12, 2000 Closing Date: January 16, 2003



    Permanently Closed
    I86NCIC CTG Phase I Study of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) Formulation Given as a 24 Hour Continuous Infusion Weekly x 4 Every 5 Weeks

    NCIC CTG Phase I Study of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) Formulation Given as a 24 Hour Continuous Infusion Weekly x 4 Every 5 Weeks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 13, 1995 Closing Date: October 28, 1996



    Permanently Closed
    I85A Phase I Study of BMS-182751 (JM-216) and Etoposide in Patients With Previously Untreated Cancer

    A Phase I Study of BMS-182751 (JM-216) and Etoposide in Patients With Previously Untreated Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 22, 1994 Closing Date: November 08, 1994



    Permanently Closed
    I218A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
    The main purpose of this study is to determine the best dose of vinblastine that can be given with temsirolimus in children with lymphoma or solid tumours including CNS tumours and to describe the associated toxicities and anti-tumour activity. Additional research will investigate how temsirolimus is absorbed and how long temsirolimus stays in the body and what effects temsirolimus is having on the cancer cells.
    A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours

    Complexity Level: 1

    Eligibility: Pediatric patients (age >= 1 year and <=18 years) with histologically confirmed, relapsed/refractory solid tumour, CNS/localized brainstem tumour or Lymphoma (Phase II - low-grade glioma). Patients must have had a least one prior treatment regimen and have adequate washout. Prior therapy with vinblastine and mTOR inhibitors (e.g. temsirolimus or sirolimus) permitted. Prior surgery and radiation permitted provided adequate time has elapsed form last dose. Adequate organ function. No untreated brain metastases, untreated spinal cord compression or meningeal metastases for patients with lymphoma or solid tumours except primary CNS tumours.

    Objectives: PRIMARY - To determine the recommended phase II dose (RP2D) of the combination of vinblastine and temsirolimus (administered as a weekly intravenous dose) in children with recurrent or refractory solid tumours including central nervous system (CNS) tumours and lymphoma and to describe the associated toxicities in children. SECONDARY - (1) To assess the anti-tumour activity of vinblastine in combination with temsirolimus in pediatric solid tumours; (2) To characterize the pharmacokinetics of temsirolimus in whole blood (including its principal metabolite sirolimus) when administered in combination with vinblastine; (3) To assess the pharmacodynamics of this regimen by evaluating change in plasma cytokines and angiogenic factors (CAF) and mTOR inhibition in peripheral mononuclear cells as a biomarker of target inhibition.

    NCT Registration ID (from clinicaltrials.gov): NCT02343718
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: June 02, 2015 Closing Date: March 31, 2017



    Permanently Closed
    I212A Pilot Study of Imetelstat given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children with Recurrent and/or Refractory Neuroblastoma.
    The main purpose of this study is to see if imetelstat can be given at the recommended dose, alone and together with the 13-cis-retinoic acid and whether it has an effect on specific bone marrow and blood cells. Additional research will investigate certain biomarkers in the blood and bone marrow to see if there is any relation to response to treatment.
    A Pilot Study of Imetelstat given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children with Recurrent and/or Refractory Neuroblastoma.

    Complexity Level: 1

    Eligibility: Patients must have recurrent or refractory neuroblastoma which is histologically verified at either original diagnosis or relapse.

    Objectives: 1.1 In patients with relapsed and/or refractory neuroblastoma, to confirm the feasibility of administering imetelstat given at the recommended pediatric dose as determined in the Children's Oncology Group Study ADVL1112 (a phase I study of imetelstat, a telomerase inhibitor, in children with recurrent or refractory solid tumours and lymphoma), alone and in combination with 13-cis-retinoic acid. 1.2 In patients with relapsed and/or refractory neuroblastoma to assess the impact of imetelstat on hematopoietic stem cells and neuroblastoma tumour initiating cells. 1.3 In patients with relapsed and/or refractory neuroblastoma to evaluate: - The correlation of tumour and plasma C-circles. - The role of plasma C-circles as a tumour biomarker for alternative lengthening of telomeres (ALT). - Changes in plasma C-circles induced by treatment with imetelstat.

    NCT Registration ID (from clinicaltrials.gov): NCT01916187
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 30, 2013 Closing Date: November 22, 2013



    Permanently Closed
    I188A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer
    The main purpose of this study is to find out what dose of an experimental drug called SB939 is safe to give to patients with advanced cancer without too many side-effects. Researchers will also look at blood levels to find out how the drug is distributed in the blood and what effects it will have on the tumour.
    A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer

    Eligibility: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumours, refractory to standard therapy or for which conventional therapy is not effective. No anti-cancer treatment <= 28 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No pre-exisitng peripheral neuropathy >= gr 2.

    Objectives: 1.1 The primary objective of this study is to determine the recommended phase II dose of oral SB939 in patients with solid tumours. SB939 will be administered initially for 3 consecutive days every other week and then for 5 consecutive days every other week at escalating doses. 1.2 To determine the toxic effects of SB939 given in this schedule, their association with dose and pharmacokinetics 1.3 To assess the pharmacokinetic profile of SB939 given in this schedule 1.4 To assess preliminary evidence of anti-tumour effects in patients with measurable disease by documentation of objective response 1.5 To establish proof-of-principle for SB939 effects on histone acetylation by evaluation of histone acetylation and other biomarkers in peripheral blood mononuclear cells (PBMCs) at all dose levels and in tumour tissue at the recommended phase II dose level

    NCT Registration ID (from clinicaltrials.gov): NCT00504296
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2007 Closing Date: March 16, 2010



    Permanently Closed
    I181NCIC CTG Phase I Study Of AT9283 Given As A 24 Hour Infusion On Days 1 And 8 Every Three Weeks In Patients With Advanced Incurable Malignancy
    The purpose of this study is to find the highest dose of a new drug AT9283 that can be given without causing very severe side effects that are not tolerable.
    NCIC CTG Phase I Study Of AT9283 Given As A 24 Hour Infusion On Days 1 And 8 Every Three Weeks In Patients With Advanced Incurable Malignancy

    Eligibility: Advanced and/or metastatic solid tumours; non-Hodgkin's lymphoma judged to be refractory to standard therapies. Up to two prior chemotherapy regimens for metastatic disease permitted in patients with solid tumours; no chemotherapy limitations for non-Hodgkin's lymphoma patients.

    Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks in patients with advanced incurable malignancy.

    NCT Registration ID (from clinicaltrials.gov): NCT00443976
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 04, 2007 Closing Date: November 24, 2009



    Permanently Closed
    I179Phase I Study Of CCI-779 In Combination With Carboplatin And Paclitaxel In Patients With Advanced Solid Tumours.
    In this trial, a new type of cancer drug called CCI-779 is being added to carboplatin and paclitaxel to see if this treatment will work better than carboplatin and paclitaxel alone. The purpose of this study is to find the dose and schedule of CCI-779 that can be given along with carboplatin and paclitaxel without causing side effects that are too severe and not tolerable. New patients will continue to join the study until full doses of carboplatin and paclitaxel are given and CCI-779 is given every week, unless the lower doses cause severe side effects. Patients will be enrolled in Part A or Part B, depending on what time they join. The main difference is that in Part A, CCI-779 is given twice and in Part B it is given 3 times. Patients entered in the Part B portion of this study will also have blood samples taken to measure the levels of the 3 drugs in the blood to determine how quickly these drugs are removed from the body.
    Phase I Study Of CCI-779 In Combination With Carboplatin And Paclitaxel In Patients With Advanced Solid Tumours.

    Eligibility: Patients with histological confirmed advanced solid tumours for which therapy with carboplatin and paclitaxel is a reasonable therapeutic option (at expanded cohort at recommended dose: endometrial cancer or ovarian cancer patients only). Measurable or non-measurable disease (except in expanded cohort at recommended dose: all patients must have measurable disease).

    Objectives: To establish the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) of CCI 779 in combination with carboplatin and paclitaxel, administered intravenously on day 1 of a three week cycle, in patients with advanced solid cancers. To describe the frequency and severity of toxic effects of the combination of carboplatin, paclitaxel and CCI-779 given at the recommended dose and schedule. To document any evidence of objective antitumour activity of the combination of CCI-779 with carboplatin and paclitaxel, in those patients with measurable disease. To determine the pharmacokinetic profile of carboplatin, paclitaxel alone and with CCI-779 co-administration within patients, and to determine the pharamacokinetic profile of CCI-779 alone and with carboplatin and paclitaxel co-administration within the same patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00408655
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 25, 2006 Closing Date: March 27, 2009



    Permanently Closed
    I177A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable Malignancy
    The purpose of this study is to find out how much of the drug AT7519M can be given safely to patients with cancer when administered twice a week. This is done by starting at a dose already known to be safe in humans.
    A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable Malignancy

    Complexity Level: 1

    Eligibility: Advanced/metastatic solid tumour or non-Hodgkins lymphoma. Patients with solid tumours may not have had more than 2 prior regimens for metastatic disease; patients with non-Hodgkins lymphoma must have, in the opinion of the investigator, failed all standard therapies.

    Objectives: To determine the safety, tolerability, toxicity profile and define a recommended phase II dose of AT7519M given as a one hour infusion twice weekly for two weeks every 21 days in patients with advanced incurable malignancy.

    NCT Registration ID (from clinicaltrials.gov): NCT00390117
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 22, 2006 Closing Date: April 04, 2011



    Permanently Closed
    I154A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel
    This is a research study for patients who have been diagnosed with prostate, renal cell, bladder, breast or ovarian cancer and have either progressed on previous therapy or for whom no curative therapy exists. The purpose of the study is to find out how much of the experimental new drug, OGX-011, can be given in combination with docetaxel without too many side-effects and what effects it will have on the tumour. Two schedules will be explored. Schedule 'A' - patients who meet the eligibility criteria will be given OGX-011 as a 2-hour infusion weekly, (with a loading dose on days 3 and 5 cycle 1 only) for 6 weeks. Docetaxel will be given as a 1 hour infusion for 5 of the 6 weeks beginning day 1, immediately following the OGX-011 infusion. Schedule 'B' - patients who meet the eligibility criteria will receive OGX-011 by 2 hour infusion, loading doses on days -7, -5, -3 and then weekly. Docetaxel will be given as a 1 hour infusion day 1 every 3 weeks.
    A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel

    Eligibility: Histologic or cytologic evidence of a solid tumour that has been shown to overexpress clusterin (prostate, renal cell, bladder, breast, ovarian cancers). Must have metastatic or locally recurrent disease that is either refractory to standard curative therapy or for which no curative therapy exists. No limit to the number of previous chemotherapy, hormone therapy for patients enrolled to schedule 'A' but limit of <= 2 prior regimens if registered to schedule 'B'.

    Objectives: To determine the toxicity and define the recommneded phase II dose of OGX-011 when given in combination with docetaxel. To determine the pharmacokinetic profile of OGX-011 and weekly docetaxel when administered in combination. To measure evidence of effect on serum clusterin levels and clusterin expression in PBMC and accessible tumours. To document any objective responses.

    NCT Registration ID (from clinicaltrials.gov): NCT00471432
    Participation: Limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 06, 2003 Closing Date: June 28, 2005



    Permanently Closed
    I147Phase I Study of GS7836 in Patients With Advanced Incurable Solid Tumours
    The purpose of this study is to test the safety of this new drug GS7836 and to find out how much GS7836 can be given to cancer patients without causing side effects that are too severe. This is done by starting at a dose lower than the one that does not cause side effects in animals. Patients are given GS7836 and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of GS7836. Patients joining the study later on will get higher doses of GS7836 than patients who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.
    Phase I Study of GS7836 in Patients With Advanced Incurable Solid Tumours

    Eligibility: Histologically or cytologically documented solid tumour cancer. Clinically or radiologically documented disease. Up to three prior chemotherapy regimens permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of GS7836 in patients with solid tumours. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and PK profile of GS7836. To assess the anti-tumour activity of GS7836 in patients with measurable disease.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 28, 2001 Closing Date: February 17, 2004



    Permanently Closed
    I131A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer
    The purpose of this study is to find out how much docetaxel and ZD0473 can be safely given to patients with cancer. Drugs like docetaxel and ZD0473 are commonly used together to treat cancer. Docetaxel and ZD0473 have not been used together in patients before. Patients are given docetaxel and ZD0473 and are watched very closely to see what side effects they have. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of each drug. This will continue until we find the highest dose of docetaxel and ZD0473 which can be safely given to patients.
    A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer

    Eligibility: Histologially documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted.

    Objectives: To determine the maximum tolerated doses and recommended doses of ZD0473 and docetaxel when given in combination to patients with advanced cancer.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 04, 2000 Closing Date: February 08, 2002



    Permanently Closed
    I32NCIC CTG Phase I Study of Trimetrexate Glucuronate Daily x 9 Bolus

    NCIC CTG Phase I Study of Trimetrexate Glucuronate Daily x 9 Bolus

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1985 Closing Date: December 01, 1985



    Permanently Closed
    I166BThis is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

    This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

    Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel.

    NCT Registration ID (from clinicaltrials.gov): NCT00372736
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 20, 2006 Closing Date: March 20, 2008



    Permanently Closed
    I44NCIC CTG Phase I Study of CI-937 Given Weekly x 3 Every 5 Weeks

    NCIC CTG Phase I Study of CI-937 Given Weekly x 3 Every 5 Weeks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 18, 1988 Closing Date: March 11, 1991



    Permanently Closed
    I166This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

    This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

    Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel.

    NCT Registration ID (from clinicaltrials.gov): NCT00357747
    Participation: Participation in this phase I study is restricted to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 2005 Closing Date: July 10, 2006



    Permanently Closed
    I36NCIC CTG Phase I Study of Didemnin-B Weekly x 4 q 6 wks

    NCIC CTG Phase I Study of Didemnin-B Weekly x 4 q 6 wks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 01, 1986 Closing Date: November 29, 1991



    Permanently Closed
    I67NCIC CTG Phase I Study Of Fostriecin Given as an Intravenous Bolus Daily for 5 Consecutive Days

    NCIC CTG Phase I Study Of Fostriecin Given as an Intravenous Bolus Daily for 5 Consecutive Days

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 10, 1992 Closing Date: May 21, 1996



    Permanently Closed
    I121A Phase I Study of LY335979 Administered in Combination With Vinorelbine in Patients With Solid Cancers

    A Phase I Study of LY335979 Administered in Combination With Vinorelbine in Patients With Solid Cancers

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1999 Closing Date: November 06, 2000



    Permanently Closed
    I144A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid Tumours
    The purpose of this study is to find out how much of the drugs irinotecan and LY293111, when taken in combination, can be given safely to patients with cancer. This is done by starting LY293111 at a dose that is lower than the dose that can safely be given to animals. The starting dose of irinotecan is known to be safe for humans. Patients are given irinotecan and LY293111 and are watched very closely to see what side effects they have. If the side effects are not severe, then more patients are asked to join the study and are given a higher dose of LY293111 and/or irinotecan. This will continue until we find the highest doses of both irinotecan and LY293111 which can be safely given in combination to patients.
    A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid Tumours

    Eligibility: Histologically or cytologically documented evidence of advanced and/or metastatic solid tumours with up to two prior chemotherapy regimens.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of the combination of irinotecan and LY293111 when IV irinotecan is given on day 1 every 3 weeks and LY293111 is given orally twice daily from the evening of day 2 onward. To determine the toxic effects of this combination and define the duration and reversibility of these effects. To determine the pharmacokinetics of drug-drug interaction of this combination and to assess the clinical response rates in patients with measurable disease treated with this combination.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 23, 2001 Closing Date: June 29, 2004



    Permanently Closed
    I43NCIC CTG Phase I Study of CI-937 Bolus q 3 to 4 wks

    NCIC CTG Phase I Study of CI-937 Bolus q 3 to 4 wks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 19, 1988 Closing Date: August 10, 1990



    Permanently Closed
    I203A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia.

    A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia.

    Complexity Level: 1

    Eligibility: Part A. Patients must have recurrent or refractory solid tumours, lymphoma or CNS tumours (excluding diffuse intrinsic pontine gliomas). Part B. Patients must have recurrent or refractory leukemia. Part C. Patients must have neuroblastoma, or medulloblastoma/CNS primitive neuroectodermal tumour (PNET). All patients must have histologic verification of malignancy, adequate bone marrow, renal, cardiac and liver function, and must meet all other eligibility criteria as defined in Protocol Section 5.

    Objectives: Part A. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of oral SB939 in pediatric patients with solid tumours, with SB939 administered orally every other day three times/week for three consecutive weeks, followed by one week off-dosing. Part B. To assess the tolerability of the solid tumour RP2D in patients with recurrent or refractory leukemia once the RP2D has been established in solid tumours. Part C. To determine the RP2D of oral SB939 in combination with a fixed dose of 13-cis-retinoic acid in children with refractory or recurrent neuroblastoma, medulloblastoma/CNS neuroectodermal tumour (PNET), using the recommended dose determined in Part A of this study. To characterize the pharmacokinetics of SB939 in a pediatric population. To describe any antitumour activity of SB939 in pediatric tumours when given as a single agent, and when given in combination with 13-cis-retinoic acid.

    NCT Registration ID (from clinicaltrials.gov): NCT01184274
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 21, 2010 Closing Date: January 25, 2012



    Permanently Closed
    I115A Phase I Study of Aplidine Given as a 1 Hour IV Infusion Daily x 5 Days Every 3 Weeks in Patients with Solid Tumours or Low or Intermediate Grade Non-Hodgkin's Lymphoma Refractory to Standard Curative Therapy

    A Phase I Study of Aplidine Given as a 1 Hour IV Infusion Daily x 5 Days Every 3 Weeks in Patients with Solid Tumours or Low or Intermediate Grade Non-Hodgkin's Lymphoma Refractory to Standard Curative Therapy

    Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours or refractory low/intermediate grade NHL. Prior chemotherapy and radiotherapy permitted. No patients with pre-existing neuropathies permitted.

    Objectives: To determine the maximum tolerated dose (MTD) of aplidine given as a 1 hour infusion daily x 5 every 3 weeks. To determine safety, toxicity profile and pharmacokinetics of aplidine given in this schedule. To examine efficacy of aplidine given in this schedule.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 15, 1999 Closing Date: February 07, 2002



    Permanently Closed
    I96NCIC CTG Phase I Study of JM216 Plus VP16(Etoposide)

    NCIC CTG Phase I Study of JM216 Plus VP16(Etoposide)

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 15, 1996 Closing Date: June 03, 1999



    Permanently Closed
    I125A Phase I Study Of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

    A Phase I Study Of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003890
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 22, 1999 Closing Date: March 08, 2001



    Permanently Closed
    I123A Phase I Study of NX-211 Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients with Solid Tumours

    A Phase I Study of NX-211 Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients with Solid Tumours

    NCT Registration ID (from clinicaltrials.gov): NCT00003891
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 25, 1999 Closing Date: June 09, 2000



    Permanently Closed
    I113NCIC CTG Phase I Interaction Study Between BAY 12-9566 and Modulated Dose Intensive Fluorouracil (Arm A) or Doxorubicin (Arm B) in Cancer Patients

    NCIC CTG Phase I Interaction Study Between BAY 12-9566 and Modulated Dose Intensive Fluorouracil (Arm A) or Doxorubicin (Arm B) in Cancer Patients

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 1998 Closing Date: September 20, 1999



    Permanently Closed
    I107NCIC CTG Phase I Study of BAY 12-9566 in Patients With Advanced Cancer

    NCIC CTG Phase I Study of BAY 12-9566 in Patients With Advanced Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1997 Closing Date: December 10, 1997



    Permanently Closed
    I103NCIC CTG Phase I Study of BCH-4556 Given as a 30 Minute Infusion Every 3 Weeks

    NCIC CTG Phase I Study of BCH-4556 Given as a 30 Minute Infusion Every 3 Weeks

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1997 Closing Date: March 02, 1999



    Permanently Closed
    I136A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma

    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): NCT00005974
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 2000 Closing Date: March 06, 2001



    Permanently Closed
    I77NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma

    NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 28, 1994 Closing Date: June 30, 1995



    Permanently Closed
    I71NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma

    NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 08, 1992 Closing Date: February 04, 1994



    Permanently Closed
    I155A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
    This is a research study for patients with soft tissue sarcoma which either has not been treated or has come back since the last treatment. The purpose of the study is to find out what effects an experimental new drug, perifosine, will have on soft tissue sarcoma, and what side effects it may produce in a patient. Patients who are eligible for the study will take perifosine by mouth every day for 21 days, followed by 7 days without treatment. Treatment will be repeated every 4 weeks.
    A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

    Eligibility: Patients with histologically documented metastatic or locally advanced soft tissue sarcoma that is not curable by other means. Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is permitted.

    Objectives: To assess the efficacy & toxicity of perifosine given by mouth for 3 weeks every 4 weeks in patients with untreated, metastatic or locally advanced soft tissue sarcoma. progression rate, and, if responses are observed, response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00053794
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 15, 2003 Closing Date: August 10, 2004



    Permanently Closed
    I15NCIC CTG Phase II Study of Mitoxantrone in Sarcoma

    NCIC CTG Phase II Study of Mitoxantrone in Sarcoma

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 03, 1984 Closing Date: December 09, 1985



    Permanently Closed
    I28ANCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma

    NCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 25, 1988 Closing Date: January 09, 1989



    Permanently Closed
    I29NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma

    NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 21, 1986 Closing Date: November 03, 1987



    Permanently Closed
    I28NCIC CTG Phase II Study of Trimetrexate in Sarcoma

    NCIC CTG Phase II Study of Trimetrexate in Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: December 31, 1987



    Permanently Closed
    I55NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma

    NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 04, 1990 Closing Date: March 06, 1992



    Permanently Closed
    I200A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.
    The main purpose of this study is to find out how effective the study drug SB939 is in treating specific types of sarcoma cancer. Treatment will be SB939 given by mouth every other day for 3 times a week for 3 consecutive weeks followed by one week off. Patients will be those who meet all of the eligibility criteria. Treatment will be repeated every 4 weeks (1 cycle = 4 weeks) and will continue for up to 6 cycles as long as the cancer does not progress and the side effects are not too severe and the patient wishes to. If patients achieve a response to treatment, they may be on the study until the cancer worsens or for up to 12 cycles.
    A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.

    Complexity Level: 2

    Eligibility: Patients with histologically diagnosed translocation-associated sarcoma. Patients must have measurable disease. A tissue block from primary or metastatic tumour must be available for confirmation of diagnosis, translocation subtype and correlative studies. Up to 1 prior chemotherapy regimen in the metastatic setting is permitted. Prior radiation permitted. No pathologic cardiac arrhythmia within previous 12 months or myocardial infarction within 6 months. Acceptable end-organ function. ECOG 0, 1 or 2.

    Objectives: To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas. To determine response duration, stable disease rate and progression free survival in these patients. To determine the tolerability and toxicity of SB939 in this population. To explore potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT01112384
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 18, 2010 Closing Date: January 25, 2012



    Permanently Closed

    Lung

    IDStudy TitleStatus
    BRC7 (ECOG-ACRIN EA5163)INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis

    INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis

    Complexity Level: 2

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    BR36 (CRI-CCTG-0002)A Biomarker-Directed, Open Label, Multi-Centre Phase II Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients with NSCLC

    A Biomarker-Directed, Open Label, Multi-Centre Phase II Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients with NSCLC

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    BRC8 (SWOG S1827)A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation in Small-Cell Lung Cancer

    A Randomized Phase III Trial of MRI Surveillance with or without Prophylactic Cranial Irradiation in Small-Cell Lung Cancer

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    BR31A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
    The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.
    A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Completely resected primary stage IB (>= 4cm), II and IIIA non-small cell lung cancer patients (with or without adjuvant platinum based chemotherapy).

    Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Disease free survival (DFS) in all randomized patients. Secondary Objectives: Overall survival (OS) for patients with NSCLC that is PD-L1 positive, OS for all randomized patients, lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients, adverse effects and tolerability of MEDI4736, Quality of Life, survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, economic evaluation (cost effectiveness and cost utility), evaluation of predictive/prognostic significance of PD-L1 expression, evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event, exploratory pharmacogenomic assays (baseline only).

    NCT Registration ID (from clinicaltrials.gov): NCT02273375
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 09, 2014



    Open to Accrual
    BR16 (ECOG E5597)Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer
    The purpose of this study is to find out whether it is better to receive a high selenium yeast tablet or better to receive no further treatment after surgery to remove non-small cell lung cancer. To do this, half of the patients in this study will get the high selenium yeast tablets and the other half will receive placebo yeast tablets (a placebo is a substance that does not do anything).
    Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer

    Complexity Level: 3

    Eligibility: Patients who have undergone complete resection of a histologically proven stage 1A (pT1N0) or 1B (pT2N0) non-small cell lung cancer (except carcinod) who are currently free of disease. To be pathologic stage N0, at least one mediastinal node must have been sampled at resection. Centres who are participating on NCIC CTG study BR.10 may not randomize patients with stage T2N0 until BR.10 closes to accrual.

    Objectives: To evaluate the efficacy of selenium supplementation in reducing the incidence of second primary lung tumours in patients who have been treated for Stage 1 non-small cell lung cancer with complete surgical resection. To evaluate the qualitative and quantitative toxicity of selenium supplementation in a daily administration schedule. To compare the incidence of specific cancers and mortality from cancer as well as overall survival of patients treated with selenium supplementation versus patients treated with placebo.

    NCT Registration ID (from clinicaltrials.gov): NCT00008385
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: November 23, 2000 Closing Date: November 05, 2009



    Closed to Accrual
    BR28 (MLCG CONVERT)Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status
    2-arm randomised trial comparing: 45Gy in 30 fractions as a twice daily radiotherapy schedule (given concurrently with cisplatin/etoposide) 66Gy in 33 fractions as a once daily radiotherapy schedule (given concurrently with cisplatin/etoposide)
    Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status

    Complexity Level: 2

    Eligibility: Patients with histologically or cytologically confirmed small cell lung cancer (SCLC). Performance status must be ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator.

    Objectives: Overall survival Local progression-free survival; Metastasis-free survival; CTCAE v3.0 toxicity; Cytotoxic dose intensity; Radiotherapy dose intensity; Prospective cost-effectiveness analysis.

    NCT Registration ID (from clinicaltrials.gov): NCT00433563
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: December 09, 2008 Closing Date: July 22, 2013



    Closed to Accrual
    BRC2 (ECOG 1505)A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)
    The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer
    A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 2

    Eligibility: To be eligible for the trial, all patients must have undergone complete resection of their cancer prior to enrollment. It is expected that at a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) will be preferred.

    Objectives: Primary Objective: To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>/= 4 cm) - IIIA NSCLC. Secondary Objectives: To evaluate disease free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>/= 4 cm) - IIIA NSCLC. To perform analyses of tissue and blood to establish factors that predict for clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC. To determine whether smoking status is linked to outcome for patients with resected stage IB (>/= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting.

    NCT Registration ID (from clinicaltrials.gov): NCT00324805
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: August 28, 2007 Closing Date: September 20, 2013



    Closed to Accrual
    BRC6 (SWOG S1400)A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
    Lung-MAP (BRC.6, S1400) is a large clinical trial, or research study, testing several new treatments for patients who have advanced stage squamous cell lung cancer. In advanced stage patients, the cancer has usually spread to other organs in their body. The Lung-MAP trial is for advanced stage patients whose cancer has continued to grow, even after being treated with standard therapy. The purpose of the Lung-MAP study is to learn if the drugs that target the genetic changes in the cancer cells will slow or stop the squamous cell lung cancer from growing. For the non-match sub-study, researchers want to compare the effects ? good and bad ? of using nivolumab alone and with another immune therapy drug. Lung-MAP is focused on squamous cell lung cancer because it is common and hard to treat. There are few effective treatments for squamous patients, particularly those who don?t respond to chemotherapy.
    A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer

    Complexity Level: 2

    Eligibility: PRE-SCREENING/SCREENING ELIGIBIILITY - patients must: (1) have pathologically proven Stage I