All Disease Sites

    Brain

    IDStudy TitleStatus
    CE7A Phase III Trial of Stereotactic Radiosurgery compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases
    A Phase III Trial of Stereotactic Radiosurgery compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases

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



    Planned
    CEC5 (ALLIANCE A221208)Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases
    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: Open to Accrual
    Activation Date: December 23, 2016



    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
    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
    CE2 (RTOG 94-02)Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas.
    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: Closed to Accrual
    Activation Date: October 23, 1996 Closing Date: March 29, 2002



    Closed to Accrual
    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.
    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
    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
    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
    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
    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
    CEC1 (RTOG 0834)Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.
    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
    CE3 (26981-22981)A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme
    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
    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.
    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
    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.
    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

    Breast

    IDStudy TitleStatus
    MA39Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
    Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

    Complexity Level: 1

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: CCTG 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
    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
    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
    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: Open to Accrual
    Activation Date: January 25, 2017



    Open to Accrual
    MAC19 (ALLIANCE A011202)A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
    A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation 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
    MAC22 (ECOG-ACRIN EA1151)Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
    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 Node Positive HER2 Negative Breast Cancer: The ABC Trial
    A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive 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 within one year of diagnosis and free of recurrence. 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
    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
    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
    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
    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
    MAX1 (QMUL LATTE)Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE)
    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: Open to Accrual
    Activation Date: June 21, 2016



    Open to Accrual
    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: Closed to Accrual
    Activation Date: February 07, 2002 Closing Date: April 05, 2004



    Closed 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
    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
    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
    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: Closed to Accrual Closing Date: April 25, 2005



    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
    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)
    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
    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
    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
    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: Closed to Accrual
    Activation Date: July 17, 2008 Closing Date: December 01, 2011



    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
    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
    MAC9 (SWOG S0307)Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
    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
    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: Closed to Accrual
    Activation Date: February 11, 2005 Closing Date: November 30, 2007



    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
    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
    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.
    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
    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
    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
    MAC4C (IBCSG ANZ0701)Investigating Cognitive Function For Patients Participating In The SOFT Trial In Selected Centers
    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: Closed to Accrual
    Activation Date: June 09, 2008 Closing Date: April 30, 2010



    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
    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
    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
    MAP3A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
    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: Closed to Accrual
    Activation Date: February 11, 2004 Closing Date: March 23, 2010



    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
    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
    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
    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
    MA27 (MA27)A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer
    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
    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
    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
    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.
    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
    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
    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
    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
    MA29 (MA29)A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.
    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
    MA27D (N0434)The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27
    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
    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
    MA25 (S9927)Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes
    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
    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 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
    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 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)
    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
    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
    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
    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

    Gastro-intestinal

    IDStudy TitleStatus
    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).
    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
    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
    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)
    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: Open to Accrual
    Activation Date: October 17, 2012



    Open to Accrual
    CO28NEOadjuvant Chemotherapy, Excision and Observation for Early Recal Cancer: The NEO Trial
    NEOadjuvant Chemotherapy, Excision and Observation for Early Recal 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)
    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
    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
    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: Open to Accrual
    Activation Date: August 22, 2016



    Open to Accrual
    HE1Phase III Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases
    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: NCIC CTG 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)
    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
    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
    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
    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
    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
    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: Closed to Accrual
    Activation Date: December 12, 2006 Closing Date: April 29, 2009



    Closed to Accrual
    NEC2 (CALGB C80701)Randomized Phase II Study of Everolimus Alone versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours
    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: Closed to Accrual
    Activation Date: June 30, 2011 Closing Date: October 01, 2012



    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
    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
    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
    HEC1 (CALGB 80802)Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)
    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: Closed to Accrual
    Activation Date: January 03, 2011 Closing Date: May 21, 2015



    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.
    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
    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
    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
    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: Closed to Accrual
    Activation Date: March 03, 2008 Closing Date: March 01, 2012



    Closed to Accrual
    BI1Phase III Trial of Combined Gemcitabine Plus Capecitabine Chemotherapy Versus Gemcitabine Alone in Advanced 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
    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
    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
    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
    GA2 (AGITG AG0212OG)INTEGRATE-A Randomized Phase II Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Esophago-Gastric Cancer (AEGC)
    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
    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
    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
    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
    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
    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
    GAC1 (CALGB C80101)Phase III Randomized Study of Adjuvant Chemoradiation After Resection in Patients with Gastric or Gastroesophageal Adenocarcinoma
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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.
    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
    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
    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
    BLC3 (SWOG S1602)A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naive High-grade Non-muscle Invasive Bladder Cancer
    A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naive High-grade Non-muscle Invasive Bladder Cancer

    Complexity Level: 2

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



    Planned
    PNC1 (ECOG-ACRIN EA8134)InPACT: International Penile Advanced Cancer Trial
    InPACT: International Penile Advanced Cancer Trial

    Complexity Level: 2

    NCT Registration ID (from clinicaltrials.gov): NCT02305654
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    PRC5 (ECOG-ACRIN EA8161)Early Intervention after Radical Prostatectomy with Enzalutamide versus Androgen Deprivation Therapy in Men at Highest Risk of Metastasis by Genomic Stratification (ERADICATE)
    Early Intervention after Radical Prostatectomy with Enzalutamide versus Androgen Deprivation Therapy in Men at Highest Risk of Metastasis by Genomic Stratification (ERADICATE)

    Complexity Level: 2

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



    Planned
    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 Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

    Complexity Level: 2

    NCT Registration ID (from clinicaltrials.gov): NCT03055013
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    Planned
    BLC4 (SWOG S1605)Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer
    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
    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
    PR19A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
    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
    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 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
    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
    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
    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
    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: Closed to Accrual
    Activation Date: November 05, 2013 Closing Date: September 30, 2015



    Closed to Accrual
    PRC4 (ALLIANCE A031201)Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
    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
    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.
    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
    PR17 (ANZUP 1304)Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
    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
    PR13 (MRC PR10)RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery.
    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
    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
    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.
    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
    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
    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
    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
    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
    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
    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
    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.
    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
    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)
    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)
    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
    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
    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.
    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
    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
    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
    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
    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
    OV24A Randomized Phase II Double-Blind Placebo-Controlled Trials of Acetylsalicylic Acid (ASA) in Chemoprevention of Ovarian Cancer with BRCA 1 and 2 Mutations (STICs and STONEs).
    A Randomized Phase II Double-Blind Placebo-Controlled Trials of Acetylsalicylic Acid (ASA) in Chemoprevention of Ovarian Cancer with BRCA 1 and 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

    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG 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)
    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)
    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: On Hold
    Activation Date: January 19, 2017



    On Hold
    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.
    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
    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
    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
    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: Closed to Accrual
    Activation Date: April 02, 2008 Closing Date: December 14, 2011



    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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.
    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.
    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
    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
    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
    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
    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
    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
    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
    GT1 (0174)A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia
    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
    EN5A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium
    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.
    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
    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
    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
    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

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



    Planned
    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)
    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.

    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    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
    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
    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
    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.
    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
    LY18An Open-Label Phase I Dose-Escalation Study of Venetoclax in Combination with Rituximab, Gemcitabine, Dexamethasone and Cisplatin in Patients with Relapsed or Refractory Diffuse Large B cell Lymphoma
    An Open-Label Phase I Dose-Escalation Study of Venetoclax in Combination with Rituximab, Gemcitabine, Dexamethasone and Cisplatin in Patients with Relapsed or Refractory Diffuse Large B cell Lymphoma

    Complexity Level: 2

    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.
    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
    LY17A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma
    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: Open to Accrual
    Activation Date: May 05, 2015



    Open 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
    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: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 29, 2016



    Open to Accrual
    AL5 (DFCI 06-254)Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial
    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).
    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
    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
    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
    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.
    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
    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)
    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
    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
    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.
    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: Closed to Accrual
    Activation Date: April 30, 2013 Closing Date: April 26, 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
    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
    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)
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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

    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
    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
    MY11A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma
    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
    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)
    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)
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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.
    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
    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
    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
    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
    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

    Ind

    IDStudy TitleStatus
    I222A Phase I/II Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme
    A Phase I/II 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: Open to Accrual
    Activation Date: January 13, 2016



    Open 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
    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
    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.
    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
    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
    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
    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
    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
    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
    I213A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer
    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: Closed to Accrual
    Activation Date: July 30, 2012 Closing Date: April 20, 2016



    Closed to Accrual
    I229A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab
    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
    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
    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
    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
    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
    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.
    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
    I210A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.
    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: Closed to Accrual
    Activation Date: June 11, 2012 Closing Date: February 12, 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
    I168A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
    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
    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
    I187A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer
    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
    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
    I146A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
    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
    I234Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol
    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.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    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
    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.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    I234AA Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastiatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
    A Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastiatic 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.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    I234BA Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
    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.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    Planned
    I223A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer
    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
    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
    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
    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
    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
    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
    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
    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
    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
    I195A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer
    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
    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
    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
    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 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
    I167Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer
    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
    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
    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
    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
    I199A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.
    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
    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
    I185A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    I216Phase II Study of Buparlisib 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
    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
    I194A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma
    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
    I191A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma
    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
    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 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
    I172Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.
    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
    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
    I150A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
    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
    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.
    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
    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
    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
    I227A Phase II Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma
    A Phase II 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: Primary - 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 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
    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: Closed to Accrual
    Activation Date: October 15, 2012 Closing Date: August 06, 2015



    Closed to Accrual
    I215A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.
    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: Closed to Accrual
    Activation Date: January 30, 2013 Closing Date: October 16, 2015



    Closed 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
    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
    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
    I207A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma
    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
    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
    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
    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
    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
    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
    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.
    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
    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
    I183A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma
    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
    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
    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
    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: Open to Accrual
    Activation Date: May 12, 2016



    Open 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
    I202A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma
    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
    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
    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
    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
    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
    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
    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
    I189A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma
    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
    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
    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: Open to Accrual
    Activation Date: October 31, 2014



    Open to Accrual
    I228A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours
    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
    I231A Phase I/II Study of CX5461
    A Phase I/II 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: Open to Accrual
    Activation Date: May 16, 2016



    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 Including CNS Tumours.
    A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours Including CNS 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: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: November 03, 2014



    Open to Accrual
    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
    I221A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies
    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
    I218A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
    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: Closed to Accrual
    Activation Date: June 02, 2015 Closing Date: March 31, 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
    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
    I130A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer
    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
    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
    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
    I188A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer
    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
    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.
    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
    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
    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
    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
    I134A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks
    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
    I131A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer
    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
    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
    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
    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
    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
    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
    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.
    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
    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
    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
    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
    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
    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
    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
    I200A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.
    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
    I155A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma
    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

    Lung

    IDStudy TitleStatus
    BRC6F (SWOG S1400F)A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)
    A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must:(1)be assigned to BRC6F (2)have progressed during/after prior platinum-based chemo, or after anti-PD-1/anti-PD-L1 Ab monotherapy (3)no prior exposure to CTLA-4 inhibitors (ipilimumab & tremelimumab) (4)not received nitrosoureas or mitomycin-c within 42 d (5)no prior autoimmune/inflammatory disease within 3 y (6)no history of primary immunodeficiency (7)no immunosuppressive meds within 28 d. Systemic corticosteroids stopped at least 24 h (8) no Gr 3 or worse irAE (9)no organ transplant that requires immunosuppressives (10)no allergy/reaction to Durvalumab &/or tremelimumab (11)no active tuberculosis infection (12)no live attenuated vaccination within 28 d (13)no known HIV, or + test for Hep B virus surface antigen (HBV sAg), or Hep C virus ribonucleic acid (HCV Ab) indicating current acute/chronic infection (14)have TSH with reflex T3/T4 free (if TSH is out of normal range) & ECG within 7 d (15)specimen banking (16)see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to evaluate ORR (confirmed & unconfirmed, CR & PR) by RECIST 1.1 among patients treated with Durvalumab + Tremelimumab (2) to estimate DoR among patients who achieve a CR or PR (confirmed and unconfirmed) by RECIST 1.1 (3) to estimate the DoR per immune-related response criteria for patients who achieve a CR or PR (confirmed & unconfirmed) by RECIST 1.1 (4) to evaluate OS for patients treated with Durvalumab + Tremelimumab (5) to evaluate IA-PFS for patients treated with Durvalumab + Tremelimumab (6) to evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) for patients treated with Durvalumab + Tremelimumab (7) to evaluate the frequency & severity of toxicities associated with Durvalumab + Tremelimumab (8) to explore the association of potential predictive markers identified in BRC6A, with response & PFS (9) to explore the association of PD-L1 expression status with response & PFS (10) to contribute to an ongoing BRC6 serum & tumor bank.

    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
    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). After 600 patients have been accrued, only patients with PD-L1 positive tumours will be enrolled.

    Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Secondary Objectives: DFS in all randomized patients, 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
    BR34A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with High-Risk Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
    A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with High-Risk Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 2

    Eligibility: - histologically and/or cytologically confirmed squamous or non-squamous NSCLC confirmed by IHC. Known EGFR mutations or ALK fusions are NOT eligible. - high risk (defined as one or more of the following: stage IVB, or IVA with either elevated LDH, weight loss greater than or equal to 5% over past 3 months, poorly differenced histology) - must consent to tissue submission for PD-L1 testing. - measureable disease (RECIST 1.1) assessed within 28 days prior to randomization - 18 years of age or older - ECOG 0 or 1 - adequate hematology and biochemistry - no prior cytotoxic chemotherapy for advanced/metastatic disease - no prior EGFR, ALK inhibitors or immunotherapy

    Objectives: Primary Objective To compare the overall survival (OS) of patients receiving durvalumab, tremelimumab plus platinum-based chemotherapy to that of patients receiving durvalumab and tremelimumab alone. Secondary Objectives - To compare progression free survival (PFS; RECIST 1.1) at 1 year between arms - To compare objective response rate (ORR; RECIST 1.1 and iRECIST) between arms - To compare Quality of life (QoL) between arms - To evaluate the nature, severity, and frequency of toxicities between arms. - To evaluate the incremental cost effectiveness and cost utility ratios between arms - To correlate the expression of tissue (including PD-L1) and blood markers with outcomes and response. Exploratory Objectives - To evaluate the correlation between aberrations detected using genomic cell-free DNA in blood and outcomes - Progression free survival as defined by iRECIST

    NCT Registration ID (from clinicaltrials.gov): NCT03057106
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: February 15, 2017



    Open to Accrual
    BRC6 (SWOG S1400)A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
    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 IV squamous cell lung cancer, (2) have an adequate tissue specimen as defined in the protocol and confirmed by the local pathologist, (3) not have a known EGFR mutation or ALK fusion, (4) must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment, (5) have Zubrod PS 0-1, (4) be > or = 18 years of age, (5) be offered participation in banking for future use of specimens (6) have previously received or currently be receiving a platinum-based chemotherapy regimen.

    Objectives: (1) to establish a NCTN mechanism for genomically screening large but homogeneous cancer populations & subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol. Each of the biomarker-driven sub-studies in this protocol will evaluate a targeted therapy (TT) or targeted therapy combination (TTC) based on a designated therapeutic biomarker-drug combination, with the ultimate goal being approval of new targeted therapies in this setting. Non-match sub-studies will evaluate nonmatch therapies (NMT) in patients not eligible for any of the biomarker-driven sub-studies, also with the goal of approval (2) to evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study, (3) to establish a tissue/ blood repository from patients with refractory squamous cell cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    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 15, 2016



    Open to Accrual
    BRC6I (SWOG S1400I)A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)
    A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must (1)be assigned to BRC6I, (2) not had prior treatment with an anti-PD-1, anti-PDL1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways,(3) not have an active, known, or suspected autoimmune disease,(4) not have any known allergy or reaction to any component of the nivolumab & ipilimumab formulations,(5) not have received systemic treatment with corticosteroids or other immunosuppressive medications within 14 D,(6)not have a known + test for HBV sAg or HCV antibody indicating acute or chronic infection,(7) not have known history of testing positive for HIV or known AIDS,(8) not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity,(9) must also be offered participation in banking for future use of specimens,(10) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to compare OS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab, (2) to compare investigator-assessed PFS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab,(3) to compare the response rates (confirmed and unconfirmed, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab,(4) to compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab, (5) to evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab vs nivolumab, (6) to evaluate if there is an differential treatment effect on OS, IA-PFS, and Response by tumor PD-L1 expression status.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: April 15, 2016



    Open to Accrual
    BRC6G (SWOG S1400G)A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
    A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must: (1) be assigned to BRC6G (i.e., defined as HRRD positive),(2) not have prior exposure to any agent with a PARP inhibitor,(3) have achieved SD, a PR, or a CR at their first assessment after initiating first-line platinum-based chemotherapy, (4) not have any impairment of GI function or GI disease that may significantly alter absorption of talazoparib, (5) be able to take oral medications, (6) not be taking, nor plan to take while on protocol treatment strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors, (7) agree to have blood specimens submitted for PK analysis, (8) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib in HRRD MDVN-positive patients, (2) to evaluate investigator- assessed PFS (IA-PFS) & OS associated with therapy in HRRD MDVN-positive patients, (3) to evaluate ORR, IA-PFS, and OS in HRRD FMI-positive patients, (4) to evaluate ORR in HRRD MDVN-negative/ HRRD FMI-positive patients, (5) to evaluate the frequency and severity of toxicities associated with talazoparib in HRRD FMI-positive patients, (6) to assess if the HRD score is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (7) to assess if the level of PARP protein expression determined by immunohistochemistry is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (8) to characterize pharmacokinetic properties of talazoparib.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: September 20, 2017



    Open to Accrual
    BR16 (ECOG E5597)Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer
    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
    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)
    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
    BRC5 (CALGB 140503)A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (
    A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (

    Complexity Level: 1

    Eligibility: Non Small Cell Lung Cancer - Stage 1

    Objectives: Primary Objective: To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral NSCLC. Secondary Objectives: To determine whether overall survival(after sublobar resection) is non-inferior to that after lobectomy; to determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection; to determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilar and mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resection.

    NCT Registration ID (from clinicaltrials.gov): NCT00499330
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 07, 2008 Closing Date: April 04, 2017



    Closed to Accrual
    BRC2E (BRC2E)A Prospective Economic Analysis of NCIC CTG BRC.2/E1505 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)
    A Prospective Economic Analysis of NCIC CTG BRC.2/E1505 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: 3

    Eligibility: All Canadian patients registered to BRC.2.

    Objectives: Primary Objective: To determine the incremental cost effectiveness ratio of adding bevacizumab to cisplatin-based chemotherapy as adjuvant treatment after resection of Stage IB (>= 4 cm) to IIIA NSCLC in the BRC.2/E1505 (core protocol) randomized trial. Direct medical costs will be estimated from the perspective of the Canadian public healthcare system. Secondary Objectives: To determine the direct medical costs of adjuvant chemotherapy plus bevacizumab in the BRC.2/E1505 trial. To determine the incremental cost effectiveness of bevacizumab plus cisplatin-based adjuvant chemotherapy in preplanned patient subsets in the BRC.2/E1505 trial by, smoking status, stage (IB, II, IIIA, N2), gender, chemotherapy type, and predictive molecular factors, (VEGF, ICAM serum levels).

    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: August 28, 2007 Closing Date: September 20, 2013



    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
    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
    BRC6B (SWOG S1400B)A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
    A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must:(1) be assigned to BRC6B (i.e., defined as PI3K positive after biomarker testing),(2) have a HbAic <7% and fasting glucose < 125 mg/dL,(3) not have Type I or II diabetes that requires anti-hyperglycemic medication,(4) not have active or history of small or large intestine inflammation (eg. Crohn's disease or ulcertive colitis),(5) not require daily supplemental O2,(6) be able to take oral medications. Patients may not have any impairment or gastrointestinal function or disease that may significantly alter absorption of Taselisib-eg. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection,(7) not be taking, or plan to take while on protocol treatment and for 14 days post last dose of study treatment, drugs, herbal supplements, or foods that are known to be strong/moderate CYP3A4 substrates,(8) be offered participation in banking for future use of specimens,(9) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to evaluate Taselisib (GDC-0032), a PI3K inhibitor, in PI3K-positive patients,(2) within Ph II component of BRC6B, to evaluate if there is sufficient evidence to continue to Ph III,(3) to evaluate investigator-assessed PFS & OS (4)to evaluate ORR,(5) to establish a tissue/blood repository from patients with refractory lung squamous cell carcinoma, (6) to evaluate DOR,(7) to evaluate frequency & severity of toxicities associated with Taselisib,(8) to identify additional predictive tumour/blood biomarkers that may modify response or define resistence to Taselisib,(9) to identify potential resistence biomarkers at PD.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual Closing Date: December 13, 2016



    Closed to Accrual
    BRC6D (SWOG S1400D)A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
    A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must:(1)be assigned to BRC6D (i.e., defined as FGFR positive),(2)be 25 years,(3)not be taking drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4-CYP2D6 substrates,(4)not have received nitrosourea or mitomycin C within 42 D prior to sub-study registration, (5) not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology,(6)not have a mean resting QTc > 450 msec obtained from 3 consecutive ECGs,(7)not be planning to receive any concomitant medication known to prolong QT interval, (8) be able to take oral medications,(9)not have a history of hypersensitivity to active or inactive excipients of AZD4547 or with a similar chemical structure or class,(10) not have any of the listed ophthalmological criteria, (11) have an eye exam,(12)have corrected Ca and Phos < ULN,(13)have MUGA/echocardiogram,(14)be offered participation in banking for future use of specimens,(15)see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) within Ph II component of BRC6D, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR with AZD4547 in FGFR-positive patients,(2) to evaluate investigator-assessed PFS & OS in FGFR-positive patients treated with AZD4547, (3) to evaluate duration of response (DoR) among FGFR positive patients treated with AZD4547 who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with AZD4547 in FGFR positive patients, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance toAZD4547 beyond the chosen biomarker for biomarker-driven sub-studies, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual Closing Date: October 31, 2016



    Closed to Accrual
    BRC6C (SWOG S1400C)A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
    A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must: (1) be assigned to BRC6C (i.e., defined as Cell Cycle Gene Alteration Positive, (2) not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers, and/or drugs known to prolong the QT interval, (3) not have a screening QTcF interval > 480 msec based on the average of triplicate EKGs performed within 28 days prior to registration, (4) be able to take oral medications, (5) be offered participation in banking for future use of specimens,(6) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) within Ph II component of BRC6C, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR for cell cycle gene alteration positive patients registered to BRC6C treated with palbociclib,(2) to evaluate investigator-assessed PFS & OS cell cycle gene alteration-positive treatments with palbociclib, (3) to evaluate duration of response (DoR) among cell cycle gene alteration positive patients treated with palbociclib who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with palbociclib, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to palbociclib, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual Closing Date: September 01, 2016



    Closed to Accrual
    BR11 (9416)Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours): A Phase II Trial
    Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours): A Phase II Trial

    NCT Registration ID (from clinicaltrials.gov): NCT00002642
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 10, 1995 Closing Date: August 01, 1999



    Permanently Closed
    BR12A Phase III Study of Marimastat in Patients with Small Cell Lung Cancer Following a Response to First Line Chemotherapy
    A Phase III Study of Marimastat in Patients with Small Cell Lung Cancer Following a Response to First Line Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): NCT00003011
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 31, 1997 Closing Date: April 28, 2000



    Permanently Closed
    BR13 (93-09)A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection For Stage IIIA (N2) Non-Small Cell Lung Cancer
    A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection For Stage IIIA (N2) Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically proven primary non-small cell lung cancer (T 1-3, N 2-3, M0).

    Objectives: To determine if chemotherapy, radiotherapy and surgery is superior to chemotherapy and radiotherapy. To evaluate patterns of local and distant failure.

    NCT Registration ID (from clinicaltrials.gov): NCT00002550
    Participation: Limited to centres with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 15, 1996 Closing Date: November 30, 2001



    Permanently Closed
    BR18A Phase II/III Double Blind Randomized Trial of BMS-275291 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy For the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
    A Phase II/III Double Blind Randomized Trial of BMS-275291 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy For the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

    Eligibility: Histologically or cytologically confirmed diagnosis of non-small cell carcinoma of the lung. Cytologic specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable. Patients with Stage IIIB or Stage IV NSCLC, or local or metastatic failure after surgery and/or radiotherapy are eligible. Patients with Stage IIIB NSCLC without pleural effusion who are not candidates for combined modality treatment or who are being treated at centres where combined modality treatment is not the standard of practice are also eligible.

    Objectives: Phase II - To evaluate the incidence of grade 2 or higher drug related arthritis, arthralgia and/or myalgia in each arm - To estimate the objective tumour response rate in each arm - To evaluate the nature, severity, and frequency of toxicities Phase III Primary Objective: - To compare overall survival (OS) between the 2 arms Secondary Objectives: - To compare progression-free survival (PFS) - To compare response rates (RR) - To estimate time to response and response duration - To compare the nature, severity, and frequency of toxicities between the 2 arms - To correlate the expression of tissue MMP levels (at diagnosis) with outcomes and response to treatment - To correlate serum/plasma MMPs and other markers with outcomes and response to treatment - To compare Quality of Life between the 2 arms - To collect and compare resource utilization for a health economic analysis in North American centres between the 2 treatment arms

    NCT Registration ID (from clinicaltrials.gov): NCT00006229
    Participation: Limited to European and North American Centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 2000 Closing Date: May 20, 2002



    Permanently Closed
    BR21A Randomized Placebo Controlled Study of OSI-774 (Tarceva) in Patients with Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
    A Randomized Placebo Controlled Study of OSI-774 (Tarceva) in Patients with Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease

    Eligibility: Incurable stage IIIB/IV non-small cell lung cancer who have failed at least one prior regimen, but no more than two prior regimens for advanced or metastatic disease.

    Objectives: To compare overall survival; secondary endpoints include progression-free survival, response rates, duration of response, toxicity and tolerability, QoL QLQ C30 + QLQ LC13: all patients, tissue EGFR versus outcome and response, OSI-744 trough PK.

    NCT Registration ID (from clinicaltrials.gov): NCT00026325
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 14, 2001 Closing Date: January 31, 2003



    Permanently Closed
    BR22C (S9925)This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer
    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

    Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

    Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical data base to perform clinicopathologic correlation with the results of those studies.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 26, 2002 Closing Date: July 15, 2004



    Permanently Closed
    BR23C (S9925)This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer
    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

    Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

    Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical database to perform clinicopathologic correlation with the results of those studies. To test a new hypotheses as they emerge.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2004 Closing Date: October 01, 2007



    Permanently Closed
    BR25A Phase II Study of Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT)For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
    A Phase II Study of Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT)For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 1

    Eligibility: Histological or cytological confirmation of non-small cell lung cancer The following primary cancer types:squamous cell,adenocarcinoma, large cell, bronchioloalveolar cell, or non-small cell carcinoma not otherwise specified. If sputum cytology alone is used for diagnosis, this should be confirmed on a second specimen. Cytologic specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable.

    Objectives: To measure the local tumour control rate at 2 years after the delivery of an accelerated hypofractionated course of radiotherapy to patients with stage I/II (peripheral T1-3, N0, M0) non-small cell lung cancer (NSCLC). To measure the toxicities associated with the treatment, the rates of regional and distant recurrence, progression-free survival and overall survival,the changes in pulmonary function after treatment. To assess quality of life (QOL) after treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT00346320
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 26, 2006 Closing Date: April 18, 2008



    Permanently Closed
    BR6A Clinical Trial of Early Versus Late Radiotherapy for Treatment of Limited Small Cell Carcinoma of the Lung
    A Clinical Trial of Early Versus Late Radiotherapy for Treatment of Limited Small Cell Carcinoma of the Lung

    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, 1985 Closing Date: December 16, 1988



    Permanently Closed
    BR4Clinical Trial of Standard versus Alternating Combination Chemotherapy for the Treatment of Extensive Small Cell Carcinoma of the Lung
    Clinical Trial of Standard versus Alternating Combination Chemotherapy for the Treatment of Extensive Small Cell Carcinoma of the Lung

    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 11, 1982 Closing Date: April 01, 1985



    Permanently Closed
    BR1


    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: July 04, 1975



    Permanently Closed
    BRC3 (S0124)Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
    Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

    Eligibility: Histologic/cytologic confirmed E-SCLC Measurable or non-measurable disease Performance status: 0-1 Patient must be at least 3 weeks post surgery Patients with brain mets eligible only of controlled Blood counts and liver function test results must be within range provided in protocol.

    Objectives: Compare the survival of patients with extensive stage small cell lung cancer (E-SCLC) treated with cisplatin & irinotecan vs cisplatin and & compare progression-free survival, toxicities and response rate in patients with E-SCLC treated with cisplatin and irinotecan versus cisplatin and etoposide. Assess the association between UGT1A1 polymorphisms and irinotecan-associated toxicities in patients with E-SCLC. Assess the association between ERCC-1 and XRCC-1 polymorphisms and non-response to cisplatin & irinotecan & to cisplatin and etoposide.

    NCT Registration ID (from clinicaltrials.gov): NCT00045162
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 12, 2004 Closing Date: March 01, 2007



    Permanently Closed
    BR7A Pilot Study of Radiotherapy Fractionation for the Treatment of Limited Small Cell Carcinoma of the Lung
    A Pilot Study of Radiotherapy Fractionation for the Treatment of Limited Small Cell Carcinoma of the Lung

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 15, 1987 Closing Date: May 17, 1988



    Permanently Closed
    BR10A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation
    A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation

    NCT Registration ID (from clinicaltrials.gov): NCT00002583
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 07, 1994 Closing Date: April 30, 2001



    Permanently Closed
    BR5A) Clinical Trial of Two Regimens of Combination Chemotherapy Compared to Best Supportive Care or B) Clinical Trial of Two Regimens of Combination Chemotherapy for the Treatment of Extensive Non-small Cell Carcinoma of the Lung
    A) Clinical Trial of Two Regimens of Combination Chemotherapy Compared to Best Supportive Care or B) Clinical Trial of Two Regimens of Combination Chemotherapy for the Treatment of Extensive Non-small Cell Carcinoma of the Lung

    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 22, 1982 Closing Date: January 01, 1986



    Permanently Closed
    BR14 (GEM/VIN 3)A Phase III Study of Gemcitabine Plus Vinorelbine Compared to Standard Cisplatin Containing Chemotherapy For Stage IIIb or IV Non-Small Cell Lung Cancer
    A Phase III Study of Gemcitabine Plus Vinorelbine Compared to Standard Cisplatin Containing Chemotherapy For Stage IIIb or IV Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00004100
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 17, 1999 Closing Date: March 15, 2001



    Permanently Closed
    BR2Clinical Trial in Bronchogenic Carcinoma of Specific Immunotherapy as an Adjuvant to Surgery
    Clinical Trial in Bronchogenic Carcinoma of Specific Immunotherapy 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: May 01, 1978 Closing Date: December 31, 1983



    Permanently Closed
    BR20A Phase II Study of ZD6474 or Placebo in Small Cell Lung Cancer Patients Who Have Complete or Partial Response to Induction Chemotherapy Plus Radiation Therapy
    A Phase II Study of ZD6474 or Placebo in Small Cell Lung Cancer Patients Who Have Complete or Partial Response to Induction Chemotherapy Plus Radiation Therapy

    Eligibility: Patients must have histological or cytological proof of small cell carcinoma of the lung. Patients must have achieved a complete or partial response after chemotherapy +/- radiotherapy. Patients must have received a minimum of 4 cycles of the first line combination chemotherapy within 28 days of randomization. Radiology must be performed within 28 days of randomization and must show continued CR or PR. Patients must have a current performance status of ECOG 0, 1 or 2. Patient must have a life expectancy of at least 12 weeks and be 16 years of age or older.aen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test. Patient is able and willing to complete the quality of life questionnaires in either English or French. Patients registered on this trial must be treated and followed at the participating centres.

    Objectives: To compare progression-free survival (PFS) for small cell lung cancer (SCLC) patients who have received either ZD6474 or placebo. To compare the response rate (for patients with measurable disease outside the radiation field at entry) for SCLC patients who have received either ZD6474 or placebo. To compare toxicity and tolerability for SCLC patients who have received either ZD6474 or placebo. To assess pharmacokinetics for SCLC patient who received either ZD6474 or placebo: To compare QoL for SCLC patients who have received either ZD6474 or placebo. To confirm the prognostic significance of VEGFR (? p-VEGFR) expression and microvessel density in tumour with outcomes and response to treatment for consenting patients who had a histological specimen at diagnosis (section 18). To provide a comprehensive tumour, plasma and urine bank (section 17 and 18) linked to a clinical database for the further study of molecular markers in SCLC.

    NCT Registration ID (from clinicaltrials.gov): NCT00066313
    Participation: Limited to 20 NCIC CTG centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 12, 2003 Closing Date: March 13, 2006



    Permanently Closed
    BR3Clinical Trial of Alternating versus Sequential Combination Chemotherapy and Loco-regional Chemotherapy for the Treatment of Limited Small Cell Carcinoma of the Lung
    Clinical Trial of Alternating versus Sequential Combination Chemotherapy and Loco-regional Chemotherapy for the Treatment of Limited Small Cell Carcinoma of the Lung

    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, 1981 Closing Date: October 01, 1984



    Permanently Closed
    BRC4 (N0723)A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib
    A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib

    Eligibility: Documented recurrence or disease progression of NSCLC Measurable disease of at least 2cm; ECOG PS = 0, 1 or 2; Negative pregnancy test; Ability to provide informed consent; Life expectancy > 12wks; Tissue available and willing to submit tissue for EGFR evaluation; Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); Able to take folic acid, vitamin B12 supplementation, and dexamethasone; Able to permanently discontinue aspirin dose of greater or equal to 1.3 grams/day 10 days before and after pemetrexed treatment; Stable brain mets; Willingness to return to enrolling institution for treatment and follow-up.

    Objectives: Primary: To evaluate whether there are differences in progression free survival due to treatment with erlotinib compared to pemetrexed for subsets of previously treated NSCLC patients defined by epidermal growth factor receptor (EGFR)-FISH positivity versus negativity

    NCT Registration ID (from clinicaltrials.gov): NCT00738881
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 14, 2009 Closing Date: November 13, 2009



    Permanently Closed
    BRC1 (RTOG 0214)A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer
    A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Patients with Stage IIIA or IIIB non-small cell lung cancer having completed all planned definitive locoregional therapy (chemotherapy alone does not constitute definitive therapy) or locoregional and systemic therapy (with or without surgery) with complete response, partial response or stable disease after therapy. Eligible patients must have had an MRI or CT scan of the head showing no suspicion for CNS metastases within 6 weeks of study entry. Patients will not be eligible for the study if there is evidence of progressive disease, extracranial distant metastatic disease or if treated with prior cranial irradiation

    Objectives: To determine whether prophylactic cranial irradiation (PCI) improves survival after effective locoregional/systemic therapy for patients with locally advanced non-small cell lung cancer. To determine the neurolopsychologic impact of PCI, the impact of PCI on quality of life, and the impact of PCI on the incidence of CNS metastases.

    NCT Registration ID (from clinicaltrials.gov): NCT00048997
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 04, 2002 Closing Date: August 30, 2007



    Permanently Closed
    BR9A Phase III Prospective Randomized Study of Combination Chemotherapy and Surgery Versus Radiotherapy for Stage IIIA Non-Small Cell Lung Cancer
    A Phase III Prospective Randomized Study of Combination Chemotherapy and Surgery Versus Radiotherapy for Stage IIIA 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: May 05, 1993 Closing Date: November 03, 1994



    Permanently Closed
    BR8A Randomized Phase III Study of CODE Plus Thoracic Irradiation Versus Alternating CAV and EP for Extensive Stage Small Cell Lung Cancer
    A Randomized Phase III Study of CODE Plus Thoracic Irradiation Versus Alternating CAV and EP for Extensive Stage 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 16, 1992 Closing Date: April 26, 1996



    Permanently Closed
    BR29A Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
    A Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

    Complexity Level: 2

    Objectives: This is a randomized, double blind, placebo controlled study of cediranib (AZD2171) given in combination with standard paclitaxel/carboplatin chemotherapy in patients with stage IIIB or IV non-small cell lung cancer. An early futility interim analysis is planned. Primary objective: To compare the overall survival between the 2 arms

    NCT Registration ID (from clinicaltrials.gov): NCT00795340
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 06, 2008 Closing Date: May 06, 2011



    Permanently Closed
    BR26A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease
    A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease

    Complexity Level: 2

    Eligibility: Advanced previously treated Non-Small Cell Lung Cancer

    Objectives: Progression free survival and Overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT01000025
    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 04, 2009 Closing Date: June 13, 2013



    Permanently Closed
    BR24A Phase II/III Double Blind Randomized Trial of AZD2171 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
    A Phase II/III Double Blind Randomized Trial of AZD2171 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Histologically or cytologically confirmed diagnosis of stage IIIB or stage IV NSCLC. For phase II, the first 150 patients must have unidimensionally measurable disease by RECIST criteria. Prior adjuvant chemotherapy permitted (completed >=12 months), prior EGFR inhibitor therapy permitted (completed >=14 days). No prior anti-angiogenesis therapy permitted, no prior chemotherapy for metastatic or recurrent disease permitted. Patients must be > 21 days since radiation therapy and > 14 days since previous surgery.

    Objectives: Phase II: To compare the progression-free survival between arms. To compare the objective tumour response rate in each arm. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To examine pharmacogenomic and pharmacodynamic aspects of treamtent. Phase III: To compare overall survival between the two arms. To compare progression-free survival between arms. To compare objective response rates (RR) in each arm. To estimate time to response and response duration. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To correlate the expression of tissue markers (at diagnosis) with outcomes and response. To compare Quality of Life between the two arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00245154
    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: September 07, 2005 Closing Date: February 25, 2008



    Permanently Closed
    BR23 (S0220)A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours)
    A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours)

    Complexity Level: 2

    Eligibility: Histologically confirmed newly diagnosed single primary bronchogenic NSCLC,selected Stage IIB,IIIA or IIIB due to involvement of superior sulcus(T3-4,NO-1).EKG.Evidence of disease by chest x-ray (PA & lateral views),chest CT preferable w/contrast)with bone windows,CT scan of upper abd or PET scan (not necessary if chest CT incl.liver and adrenals).Biopsy or aspiration of suspicious CT/MRI findings.Pleural effusion negative per Section 5.5.Pre-resection FEV1 greater than or equal to 2.0 L,or if FEV1 less than 2.0,predicted post-resection FEV1 greater than 1.0L. PS 0-2 (PS2 must have albuin greater than or equal to 0.85 x 1LLN, wt loss less than or equal to 10%).ANC greater than or equal to 1,500,PLTS greater than or equal to 100,000.Adequate hepatic function,total bili & SGOT or SGPT less than or equal to 1.5 x 1ULN (unless benign dz present).CrCl greater than or equal to 50 ml/min. Must have mediastinal exploration w/lymph nodes biopsied except if mediastinum neg by both CT/PET.

    Objectives: The main objective of this Phase II study is to assess whether a regimen of cisplatin and etoposide with concurrent RT, followed by surgical resection and consolidation therapy with docetaxel has promise in terms of its feasibility for treating patients with Pancoast tumours Stage IIIA.

    NCT Registration ID (from clinicaltrials.gov): NCT00062439
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2004 Closing Date: October 01, 2007



    Permanently Closed
    BR22 (S9900)A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II(T1-2N1, T3N0) and Selected IIIA(T3N1) Non-Small Cell Lung Cancer.
    A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II(T1-2N1, T3N0) and Selected IIIA(T3N1) Non-Small Cell Lung Cancer.

    Complexity Level: 2

    Eligibility: Patients must have pathologic documenation of non-small cell lung cancer. Clinical stage IB (T2N0), selected clinical stage II (T1-2N1 with negative mediastinoscopy or T3N0) or selected clinical stage IIIA (T3N1) with negative mediastinoscopies. Level 10 hilar nodes may be positive as long as the mediastinoscopy is negative. All patients must have measurable disease.

    Objectives: To assess whether preoperative chemotherapy with paclitaxel and carboplatin for 3 cycles improves survival compared to surgery alone in previously untreated patients with clinical Stage 1B II and Selected III A non-small cell lung cancer (NSCLC). To compare operative mortality and other toxicities in the two study arms. To evaluate the response rates (confirmed and unconfirmed, complete and partial) and the toxicities associated with the combination of paclitaxel and carboplatin. To obtain samples for correlation of pathologic, molecular and biologic factors with outcome.

    NCT Registration ID (from clinicaltrials.gov): NCT00004011
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 26, 2002 Closing Date: July 15, 2004



    Permanently Closed
    BR19 (BR19)A Phase III Prospective Randomized Double Blind Placebo Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 (IRESSA) in Completely Resected Stage 1B, II, and IIIA Non-Small Cell Lung Cancer
    A Phase III Prospective Randomized Double Blind Placebo Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 (IRESSA) in Completely Resected Stage 1B, II, and IIIA Non-Small Cell Lung Cancer

    Eligibility: Patients who have histologic evidence of stage IB, II or IIIA primary non-small cell lung cancer that has been completely resected.

    Objectives: To compare whether adjuvant treatment with ZD1839 (IRESSA) is superiour to placebo in patients with completely resected stage IB, II and IIIA non-small cell lung cancer in terms of : overall survival and disease-free survival. To confirm the prognostic significance and to assess the predictive ability of EGFR expression, phosphorylation and mutations and the likelihood of "response" to ZD1839 (IRESSA) in terms of overall survival. A comprehensive tumour bank will be established and linked to the clinical database for the further study of molecular markers in non-small cell lung cancer. The toxicity related to ZD1839 (IRESSA) will be further evaluated.

    NCT Registration ID (from clinicaltrials.gov): NCT00049543
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 13, 2002 Closing Date: April 22, 2005



    Permanently Closed
    BR17 (08983)Phase III Study of Tomudex and Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma
    Phase III Study of Tomudex and Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma

    Eligibility: Histologically proven diagnosis of malignant mesothelioma of the pleura. Independent review of the pathology slides will be carried out on all patients.

    Objectives: To compare overall survival between the two treatment regimens in patients with malignant pleural mesothelioma. To determine toxicity, progression-free survival and Quality of Life. In the patient population with measurable disease, objective response to treatment and duration of response will be assessed.

    NCT Registration ID (from clinicaltrials.gov): NCT00004920
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 14, 2000 Closing Date: January 03, 2003



    Permanently Closed
    BR15 (S0023)A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
    A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer

    Eligibility: Either histologic or cytologic proof of a newly diagnosed single, primary bronchogenic non-small cell lung cancer is required (adenocarcinoma, non-lobar and non-diffuse bronchioloalveolar cell carcinoma, large cell carcinoma or squamous cell carcinoma). A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e. a second biopsy will not be required).

    Objectives: To assess whether cisplatin plus etoposide with concurrent radiotherapy followed by three cycles of consolidation docetaxel followed by maintenance therapy with ZD1839 compared to placebo improves overall survival and progression-free survival in patients with unresectable Stage III non-small cell lung cancer (NSCLC). To describe the toxicity profile of long-term administration of ZD1839.

    NCT Registration ID (from clinicaltrials.gov): NCT00020709
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 10, 2002 Closing Date: April 15, 2005



    Permanently Closed
    BR15C (S9925)This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer
    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

    Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

    Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical data base to perform clinicopathologic correlation with the results of those studies. To test new hypotheses as they emerge.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 2002 Closing Date: April 15, 2005



    Permanently Closed

    Melanoma

    IDStudy TitleStatus
    ME14Prophylactic Mesalamine use to Reduce Immune-related Adverse Events Associated with Combination Ipilimumab/Nivolumab for the Treatment of Metastatic Melanoma
    Prophylactic Mesalamine use to Reduce Immune-related Adverse Events Associated with Combination Ipilimumab/Nivolumab for the Treatment of Metastatic Melanoma

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



    Planned
    ME13A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)
    A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)

    Complexity Level: 2

    Eligibility: Patients with unresectable / metastatic (stage III or stage IV) melanoma, who are eligible to receive Health Canada approved, publically-funded PD-1 inhibitors.

    Objectives: PRIMARY: To determine whether the Overall Survival (OS) of patients randomized to intermittent PD-1 inhibitor therapy is non-inferior to that of patients randomized to continuous PD-1 inhibitor therapy, in unresectable / metastatic (stage III or stage IV) melanoma. SECONDARY OBJECTIVES: (1) Progression-Free Survival, (2) Response rate and duration of response, (3) Adverse Events profile, (4) Quality of LIfe and (5) Economic Evaluation

    NCT Registration ID (from clinicaltrials.gov): NCT02821013
    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 04, 2016



    Open to Accrual
    ME10 (ECOG E1697)Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) Melanoma
    Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) Melanoma

    Complexity Level: 2

    Eligibility: Patients with resected melanoma in the following categories: (1) T3-N0 (1.5-4 mm), (2) T4-N0 (> 4 mm), (3) T1-4 (microscopic, one lymph node positive).

    Objectives: To compare the effect of treatment with four weeks of high dose IFN alpha-2b versus observation on relapse free survival and overall survival. Also, toxicities and quality-adjusted survival will be compared in the two groups.

    NCT Registration ID (from clinicaltrials.gov): NCT00003641
    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 14, 1999 Closing Date: October 26, 2010



    Closed to Accrual
    MEC4 (ALLIANCE A091201)Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma
    Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma

    Complexity Level: 2

    Eligibility: Patients with ocular melanoma that is metastatic or unresectable

    Objectives: Primary Objective: Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib or temozolomide / dacarbazine. Secondary Objectives: Estimate the distribution of progression-free survival (PFS) times; Estimate the distribution of overall survival (OS) times; Estimate the confirmed response rate as determined by the RECIST criteria; Assess the safety of these agents by examining the toxicity profile; Correlate the response of MET molecular status.

    NCT Registration ID (from clinicaltrials.gov): NCT01835145
    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 09, 2015 Closing Date: May 06, 2016



    Closed to Accrual
    MEC3 (ECOG E1609)A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma
    A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have a diagnosis of primary cutaneous melanoma (high risk stage IIIB - IV as per AJCC Melanoma Staging System), and must have completely surgically resected disease at baseline. Patients must have been surgically rendered free of disease with negative margins, and must have a disease free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Some patients with disease recurrence after adequate surgical excision of the original primary melanoma are allowed as well, as specified in the protocol. A total of 1500 patients will be enrolled over 3.3 years. Accrual rate is expected to be 38 per month, and with additional follow up time, a total duration of study is expected to be less than 6 years.

    Objectives: Primary Objectives: " To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). " To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). Secondary Objectives: " To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP).

    NCT Registration ID (from clinicaltrials.gov): NCT01274338
    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 02, 2012 Closing Date: August 15, 2014



    Closed to Accrual
    MEC5 (SWOG 1404)A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma
    A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have completely resected melanoma of cutaneous origin (stage IIIA (N2a), IIIB, IIIC, or Stage IV) or of unknown primary. Patients with melanoma of mucosal or other non-cutaneous origin are eligible except for those with melanoma of ocular origin. Patients with a history of brain metastases are ineligible. For all patients, all disease must have been resected with negative pathological margins and no clinical radiologic or pathological evidence of any incompletely resected melanoma. Patients must be registered with 98 day of the last surgery performed to render the patient free of disease. Accrual rate is expected to be 45 patients per month with a total of 1240 patients enrolled in less than 2.5 years.

    Objectives: Primary Objectives: a.Compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) b.Among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) c.Compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) d.Among patients who are PD-L1 positive, to compare RFS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) Secondary Objectives: a. Estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population. b. Compare OS and RFS of patients between the two regimens within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 and treatment arm.

    NCT Registration ID (from clinicaltrials.gov): NCT02506153
    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 15, 2016 Closing Date: November 02, 2017



    Closed to Accrual
    ME5National Intergroup Protocol For Intermediate Thickness Melanomas 1.0 to 4.0mm Evaluation of Optimal Surgical Margins (2 Vs 4cm) Around the Primary Melanoma and Evaluation of Elective Regional Lymph Node Dissection
    National Intergroup Protocol For Intermediate Thickness Melanomas 1.0 to 4.0mm Evaluation of Optimal Surgical Margins (2 Vs 4cm) Around the Primary Melanoma and Evaluation of Elective Regional Lymph Node Dissection

    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 01, 1983 Closing Date: March 16, 1993



    Permanently Closed
    ME1NCIC First Cooperative Clinical Trial of Adjuvant Immunotherapy for Malignant Melanoma
    NCIC First Cooperative Clinical Trial of Adjuvant Immunotherapy for 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: February 15, 1978 Closing Date: December 31, 1982



    Permanently Closed
    ME2NCIC Collaborative Study of Vinblastine, Bleomycin and Cisplatinum in the Treatment of Metastatic Malignant Melanoma
    NCIC Collaborative Study of Vinblastine, Bleomycin and Cisplatinum in the Treatment of Metastatic 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: February 11, 1981 Closing Date: June 08, 1982



    Permanently Closed
    ME7A Comparison of Immunomodulating Doses of Human Interferon Gamma with Levamisole for the Adjuvant Treatment of Poor Prognosis Malignant Melanoma
    A Comparison of Immunomodulating Doses of Human Interferon Gamma with Levamisole for the Adjuvant Treatment of Poor Prognosis 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: November 04, 1988 Closing Date: May 10, 1990



    Permanently Closed
    ME3NCIC Study of CCNU, Vincristine and Procarbazine in the Treatment of Metastatic Malignant Melanoma
    NCIC Study of CCNU, Vincristine and Procarbazine in the Treatment of Metastatic 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 30, 1982 Closing Date: September 01, 1983



    Permanently Closed
    ME6 (8593)A Randomized Trial of Prophylactic Isolation Perfusion for Stage I High Risk Malignant Melanoma of the Limbs
    A Randomized Trial of Prophylactic Isolation Perfusion for Stage I High Risk Malignant Melanoma of the Limbs

    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: June 14, 1988



    Permanently Closed
    ME8A Double-Blind, Placebo-Controlled, Randomized Phase III Study Comparing the Complete and Partial Response Rates of a Combination of Carmustine (BCNU), Dacarbazine (DTIC) and Cisplatin With and Without Tamoxifen in Patients with Metastatic Melanoma
    A Double-Blind, Placebo-Controlled, Randomized Phase III Study Comparing the Complete and Partial Response Rates of a Combination of Carmustine (BCNU), Dacarbazine (DTIC) and Cisplatin With and Without Tamoxifen in Patients with Metastatic 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: February 26, 1992 Closing Date: January 31, 1995



    Permanently Closed

    Others

    IDStudy TitleStatus
    PM1Canadian Profiling and Targeted agent Utilization tRial (CAPTUR). A Phase II Basket Trial.
    Canadian Profiling and Targeted agent Utilization tRial (CAPTUR). A Phase II Basket Trial.

    Complexity Level: 1

    Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and have an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug.

    Objectives: PRIMARY: To evaluate the objective response rate (based on disease-appropriate objective criteria) of targeted drugs matched to pre-specified molecular aberrations (at the level of the gene) within a tumor type, among patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL) with an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug. SECONDARY: (1) To evaluate the safety of commercially available anticancer agents in patients enrolled on CAPTUR; (2) To evaluate progression free survival (PFS) based on disease-appropriate objective criteria.

    NCT Registration ID (from clinicaltrials.gov): NCT03297606
    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 06, 2017



    Open to Accrual

    Sarcoma

    IDStudy TitleStatus
    SRC6 (COG ARST1321)Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib
    Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib

    Complexity Level: 2

    Eligibility: Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk. Patients must be 2 years or older at the time of the biopsy that established the diagnosis of NRSTS.

    Objectives: Primary:Determine feasibility of pazopanib + radiation or chemoradiation (phase II. Compare rates of complete pathologic response in patients receiving radiation or chemoradiation +/- pazopanib (phase II).Compare rates of EFS in patients receiving radiation +/- pazopanib (phase III) Secondary: Estimate and compare rates of local, regional and distant failure, DFS and OS. Compare patterns of recurrence. Define toxicities of pazopanib in combination with radiation or chemoradiation.

    NCT Registration ID (from clinicaltrials.gov): NCT02180867
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: December 05, 2014



    Open to Accrual
    SR4 (SWOG S0033)Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)
    Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)

    Complexity Level: 2

    Eligibility: Patients must have a biopsy proven diagnosis of gastrointestinal stromal tumour (GIST) which is distantly metastatic or unresectable. The primary must be of visceral or intraabdominal origin. All patients must have immunohistochemical documentation of KIT (CD117) expression by tumour documented by DAKO antibody staining. Patients must have an identified team (including a medical oncologist and a surgeon) to provide care.

    Objectives: To compare overall and progression-free survival for patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing KIT (CD 117) treated with low dose STI-571 versus high dose STI-571. To assess response rates (confirmed, unconfirmed, complete and partial) and toxicities of patients treated with these two doses of STI-571. To obtain tissue and blood samples from GIST patients before and following treatment with STI-571 for future correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT00009906
    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 10, 2001 Closing Date: September 01, 2001



    Closed to Accrual
    SRC7 (ALLIANCE A091105)A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)
    A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)

    Complexity Level: 2

    Eligibility: Patients must have confirmation of DT/DF by local pathologist prior to registration. Prior therapies must have been completed at least 4 weeks prior to registration. No prior treatment with sorafenib. No concomitant treatment, in therapeutic doses, with or antiplatelet agents, or with CYP3A4 inhibitors. Patients must have measurable disease and either have unresectable disese, disease progression by radiographic imaging, or symptomatic disease which is BPI score greater than or equal to 3 and unable to control pain with NSAIDs, OR >30% increase in current use of narcotics OR addition of a new opioid narcotic. Patient must be 18 years of age or older, ECOG PS less than or equal to 2, not pregnant or nursing, no history of cardiac disease, no inadequately controlled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, no clinically significant GI bleeding or bleeding diathesis within 30 days of registration, and adequate blood counts.

    Objectives: Primary Objective: To compare the progression-free survival (PFS) rates of patients with DT/DF who receive either sorafenib or placebo using a double-blinded randomized phase III study. Secondary Objectives: To assess toxicity, to assess time to surgical intervention, to assess tumor response rates and survival.

    NCT Registration ID (from clinicaltrials.gov): NCT02066181
    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 17, 2015 Closing Date: December 01, 2016



    Closed to Accrual
    SRC1 (ACOSOG Z9001)A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST)
    A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST)

    Complexity Level: 2

    Eligibility: Patient must have a diagnosis of primary GIST confirmed histologially by central pathology review. The patient's tumor must stain positive for the Kit receptor tyrosine kinase on immunohistochemistry as determined by the Central Pathologist using the Dako anti-CD 117 antibody (Dako Corp., Carpinteria, CA). The patient must have undergone complete gross resection (includes R0 [negative microscopic margins] and R1 [positive microscopic margins] resections) of a primary GIST within 70 days prior to registration. Tumor size must be > 3 cm in maximum dimension. Post-operative chemotherapy, radiation therapy or investigational treatment will cause the patient to be ineligible, as will prior therapy with STI-571. Patients will not be eligible for randomization if they have New York Heart Association Class 3 or 4 cardiac disease, or if they are taking full-dose warfarin.

    Objectives: To ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer recurrence-free survival and overall survival as compared to the patients randomized to the Placebo Arm. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and if the patient develops recurrence), blood specimens (before therapy with STI571), and serum specimens (before therapy with STI571, after completing therapy with STI571, and if the patient develops recurrence) for scientific correlative analyses. To assess the safety/efficacy of oral STI571 therapy in the adjuvant setting.

    NCT Registration ID (from clinicaltrials.gov): NCT00041197
    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 04, 2002 Closing Date: April 18, 2007



    Closed to Accrual
    OS4 (80861)A Randomized Trial of Two Chemotherapy Regimens in the Treatment of Operable Osteosarcoma - Doxorubicin-Cisplatin vs Methotrexate-Vincristine-Doxorubicin + Doxorubicin-Cisplatin + Bleomycin-Cyclophosphamide-Dactinomycin
    A Randomized Trial of Two Chemotherapy Regimens in the Treatment of Operable Osteosarcoma - Doxorubicin-Cisplatin vs Methotrexate-Vincristine-Doxorubicin + Doxorubicin-Cisplatin + Bleomycin-Cyclophosphamide-Dactinomycin

    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: September 02, 1986 Closing Date: March 15, 1993



    Permanently Closed
    SR1 (E62874)A Randomized Phase II/III Study of Neoadjuvant Chemotherapy In Soft Tissue Sarcomas in Adults
    A Randomized Phase II/III Study of Neoadjuvant Chemotherapy In Soft Tissue Sarcomas in Adults

    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: September 12, 1989 Closing Date: February 01, 1994



    Permanently Closed
    SR5 (62012)Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma
    Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma

    Complexity Level: 2

    Eligibility: Patients with advanced or metastatic soft tissue sarcoma (FNLCC grades 2-3) with RECIST measurable lesions and at least 6 months since adjuvant chemotherapy and PS < 1 (WHO).

    Objectives: Overall survival; Response, toxicity and treatment related mortality.

    NCT Registration ID (from clinicaltrials.gov): NCT00061984
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 03, 2007 Closing Date: May 11, 2010



    Permanently Closed
    OS2The Evaluation of Cis-platinum II, Dimminedi-chloroplatinum (DDP) (NSC - 119875) in Patients With Osteosarcoma Unresponsive to Adriamycin and High-Dose Methotrexate
    The Evaluation of Cis-platinum II, Dimminedi-chloroplatinum (DDP) (NSC - 119875) in Patients With Osteosarcoma Unresponsive to Adriamycin and High-Dose Methotrexate

    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 10, 1978 Closing Date: May 01, 1980



    Permanently Closed
    OS1NCIC Osteosarcoma. A Protocol for Clinical Investigation
    NCIC Osteosarcoma. A Protocol for Clinical Investigation

    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, 1976 Closing Date: November 11, 1980



    Permanently Closed
    SR6 (TH-CR-406 / SARC021)A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
    A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

    Complexity Level: 2

    Eligibility: Male or female 15 years of age or older, has provided informed consent to participate, has pathologically confirmed diagnosis of soft tissue sarcoma for which doxorubicin is appropriate single agent therapy (see main protocol for details), disease is locally advanced unresectable or metastatic with no standard curative therapy available, measurable disease by RECIST 1.1 criteria, ECOG PS of 0 or 1, recovered from prior therapy, life expectancy of at least 3 months, acceptable blood test results for liver, renal and bone marrow function, acceptable cardiac function, must agree to use contraception.

    Objectives: PRIMARY OBJECTIVES: To evaluate the efficacy and safety of TH-302 in combination with doxorubicin as determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy (neoadjuvant and adjuvant chemotherapy permitted) compared with doxorubicin alone. SECONDARY OBJECTIVES: To evaluate the efficacy of TH-302 in combination with doxorubicin as determined by progression-free survival and response rate in subjects; to investigate the pharmacokinetics of TH-302, Br-IPM, doxorubicin and doxorubicinol in plasma. TERTIARY OBJECTIVES: to evaluate the efficacy of TH-302 in combination with doxorubicin as determined by overall survival at 6 and 12 months, progression free rate at 3 and 6 months, duration of response, stable disease or better rate, change in ECOG and performance status; to explore and compare quality of life and derive health state utilities.

    NCT Registration ID (from clinicaltrials.gov): NCT01440088
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 2012 Closing Date: December 26, 2013



    Permanently Closed
    SRC5 (S0502)A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumours
    A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumours

    Eligibility: Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) that is distantly metastatic or unresectable. Patients must be determined to be unresectable for cure.

    Objectives: Progression free survival; Economic; Correlative Biology.

    NCT Registration ID (from clinicaltrials.gov): NCT00324987
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 2009 Closing Date: September 17, 2009



    Permanently Closed
    SR2A Phase III Study of Pre-Operative External Beam Radiotherapy Compared to Post-Operative External Beam Radiotherapy in the Local Management of Curable Extremity Soft Tissue Sarcoma
    A Phase III Study of Pre-Operative External Beam Radiotherapy Compared to Post-Operative External Beam Radiotherapy in the Local Management of Curable Extremity 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: September 21, 1994 Closing Date: December 12, 1997



    Permanently Closed
    SR3 (EORTC 62931)Randomized Trial of Adjuvant Chemotherapy with High-dose Doxorubicin, Ifosfamide and Lenograstim (G-CSF) in High Grade Soft Tissue Sarcoma
    Randomized Trial of Adjuvant Chemotherapy with High-dose Doxorubicin, Ifosfamide and Lenograstim (G-CSF) in High Grade Soft Tissue Sarcoma

    Complexity Level: 2

    Eligibility: Patients with histologically proven high grade soft tissue sarcoma (grade II or III) with no evidence of metastases.

    Objectives: To compare the effect of treatment with ifosfamide and high dose doxorubicin with filgrastim versus observation on overall survival and relapse free survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00002641
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 05, 1999 Closing Date: December 15, 2003



    Permanently Closed

    Symptom Control

    IDStudy TitleStatus
    SC25Dexmedetomidine versus Midazolam or Methotrimeprazine as a Sedative Co-analgesic for Patients with Intractable Pain - A Pilot Study Using a Cluster Randomized Crossover Design
    Dexmedetomidine versus Midazolam or Methotrimeprazine as a Sedative Co-analgesic for Patients with Intractable Pain - A Pilot Study Using a Cluster Randomized Crossover Design

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



    Planned
    SC24A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) versus Conventional Palliative Radiotherapy (CRT) for Patients with Spinal Metastases
    A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) versus Conventional Palliative Radiotherapy (CRT) for Patients with Spinal Metastases

    Complexity Level: 1

    Eligibility: Patients with tumours (excluding seminoma, small cell lung cancer and metastases from hematologic malignancies) who have MRI-documented spinal metastases, suitable for receiving radiation therapy, and fulfill the following criteria: (a) Pain secondary to spinal metastases requiring treatment; (b) <=3 consecutive spinal segments involved by tumour to be included in the target volume

    Objectives: PRIMARY ENDPOINT: Phase II study: The ability to accrue 54 patients over an 18 month period to a study that randomizes patients with spinal metastases to Stereotactic Body Radiotherapy (SBRT) or Standard Conventional Radiotherapy (CRT) within a Canadian multicentre setting. Phase III study: To assess complete pain response in the treatment area at 3 months post-radiation. SECONDARY ENDPOINTS: (1) Complete pain response in the treatment area at 6 months post-radiation; (2) Radiation site progression-free survival (RSS PFS) at 3 and 6 months; (3) Adverse event profile; (4) Radiotherapy Quality Assurance (RTQA) compliance. TERTIARY ENDPOINT: Biobanking for future correlative Studies.

    NCT Registration ID (from clinicaltrials.gov): NCT02512965
    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 28, 2015



    Open to Accrual
    SC10A Randomized Controlled Phase III Trial of Clodronate in the Treatment of Bone Pain Due to Metastatic Cancer
    A Randomized Controlled Phase III Trial of Clodronate in the Treatment of Bone Pain Due to Metastatic Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 27, 1992 Closing Date: January 31, 1994



    Permanently Closed
    SC14A Phase III Double Blind Study of Theophylline versus Placebo for the Treatment of Dyspnea in Cancer Patients
    A Phase III Double Blind Study of Theophylline versus Placebo for the Treatment of Dyspnea in Cancer Patients

    NCT Registration ID (from clinicaltrials.gov): NCT00003684
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 24, 1998 Closing Date: November 08, 1999



    Permanently Closed
    SC15A Phase III Trial of Single versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patientswith Non-Small Cell Lung Cancer
    A Phase III Trial of Single versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patientswith Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003685
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1997 Closing Date: January 23, 2001



    Permanently Closed
    SC16A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth.
    A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth.

    NCT Registration ID (from clinicaltrials.gov): NCT00003686
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 22, 1998 Closing Date: November 08, 1999



    Permanently Closed
    SC17A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex Sr for Chronic Cancer Pain Relief in Terminally Ill Patients
    A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex Sr for Chronic Cancer Pain Relief in Terminally Ill Patients

    Eligibility: Patients requiring morphine for the treatment of chronic cancer pain who have been managed by a stable dose of MS contin.

    Objectives: To compare the efficacy of statex SR with that of MS contin and to assess the analgesic potential of dextromethorphan with morphine SR.

    NCT Registration ID (from clinicaltrials.gov): NCT00003687
    Participation: Limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 11, 1998 Closing Date: July 23, 2001



    Permanently Closed
    SC9An Assessment of the Effect of Schedule and Maintenance on the Antiemetic Efficacy and Safety of Ondansetron Combined With Dexamethasone as Acute and Maintenance Therapy in Patients Receiving Moderately Emetogenic Chemotherapy
    An Assessment of the Effect of Schedule and Maintenance on the Antiemetic Efficacy and Safety of Ondansetron Combined With Dexamethasone as Acute and Maintenance Therapy in Patients Receiving Moderately Emetogenic Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1991 Closing Date: August 02, 1991



    Permanently Closed
    SC18 (989255)Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement versus Both for the Treatment of Cancer Cachexia and Anorexia
    Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement versus Both for the Treatment of Cancer Cachexia and Anorexia

    Eligibility: Histologic or cytologic proven cancer other than brain, breast, ovarian, endometrial cancer or prostate cancer. If the patient has multiple primaries or an unknown primary, the currently active cancer cannot be known to be of brain, breast, ovarian, endometrial, or prostate cancer. Patient must be able to take oral medication reliably, and have a history of losing at least 5 pounds over the preceding two months or less.

    Objectives: To compare the appetite-stimulating properties of megestrol acetate versus an eicosapentaenoic acid-enriched supplement versus both for the treatment of cancer-related (and cancer treatment related) cachexia and anorexia by following patient weight, rate of weight change, and appetite. To evaluate the effect of these treatments on nausea and vomiting in patients with advanced metastatic disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00031707
    Participation: Limited to centres with a current CPA #.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 11, 2000 Closing Date: August 15, 2002



    Permanently Closed
    IC2Protocol for the Management of Febrile Granulocytopenic Patients. Tobramycin/Ticarillin versus Moxalactam/Ticarcillin as Initial Treatment for Febrile Granulocytopenic Patients
    Protocol for the Management of Febrile Granulocytopenic Patients. Tobramycin/Ticarillin versus Moxalactam/Ticarcillin as Initial Treatment for Febrile Granulocytopenic Patients

    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 31, 1981 Closing Date: October 31, 1982



    Permanently Closed
    SC7A Randomized Double-Blind Efficacy, Safety and Pharmacokinetic Study of Six Doses of the Antiemetic BMY-25801 and Methylprednisone Among Out-Patients Receiving Moderately Emetogenic Chemotherapy
    A Randomized Double-Blind Efficacy, Safety and Pharmacokinetic Study of Six Doses of the Antiemetic BMY-25801 and Methylprednisone Among Out-Patients Receiving Moderately Emetogenic Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 14, 1989 Closing Date: February 16, 1990



    Permanently Closed
    IC1A Study of the Efficacy of Lethium in Preventing Infections in Patients With Acute Leukemia
    A Study of the Efficacy of Lethium in Preventing Infections in Patients With Acute 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: December 01, 1979 Closing Date: June 01, 1982



    Permanently Closed
    IC4Comparison of Azthreonam Plus Antistaphylococcal Therapy, Azthreonam Plus Aminoglycoside, or Moxalactam Plus Aminoglycoside for the Therapy of Febrile Neutropenic Episodes in Cancer Patients Undergoing Cytotoxic Chemotherapy
    Comparison of Azthreonam Plus Antistaphylococcal Therapy, Azthreonam Plus Aminoglycoside, or Moxalactam Plus Aminoglycoside for the Therapy of Febrile Neutropenic Episodes in Cancer Patients Undergoing Cytotoxic Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1983 Closing Date: April 01, 1985



    Permanently Closed
    SC2To Evaluate the Efficacy of Methylprednisone Acetate (Depo-Medrol) in Maintaining the Anti-nauseant Effect of Methylprednisone Sodium Succinate (Solu-Medrol) in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy
    To Evaluate the Efficacy of Methylprednisone Acetate (Depo-Medrol) in Maintaining the Anti-nauseant Effect of Methylprednisone Sodium Succinate (Solu-Medrol) in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1985 Closing Date: October 06, 1986



    Permanently Closed
    SC5A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BRL 43694a in Comparison With Dexamethasone and Prochlorperazine in Patients Receiving Moderately Emetogenic Chemotherapy
    A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BRL 43694a in Comparison With Dexamethasone and Prochlorperazine in Patients Receiving Moderately Emetogenic Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 08, 1988 Closing Date: March 03, 1989



    Permanently Closed
    SC6An Assessment of the Antiemetic Efficacy, Tolerance, and Safety of GR38032f versus Dexamethasone Plus Metoclopramide in Patients With Breast Cancer Receiving "CMF" Chemotherapy
    An Assessment of the Antiemetic Efficacy, Tolerance, and Safety of GR38032f versus Dexamethasone Plus Metoclopramide in Patients With Breast Cancer Receiving "CMF" Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 1989 Closing Date: November 02, 1990



    Permanently Closed
    SC12A Phase III Study of an Assessment of the Efficacy of Dexamethasone in the Prophlaxis of Radiation Induced Emesis
    A Phase III Study of an Assessment of the Efficacy of Dexamethasone in the Prophlaxis of Radiation Induced Emesis

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 27, 1995 Closing Date: September 29, 1997



    Permanently Closed
    IC7A Multicentric, Randomized Study to Evaluate the Safety and Efficacy of Ofloxacin versus Ofloxacin Plus Rifampin versus Norfloxacin in the Prevention of Fever and Sepsis in Patients Expected to Become Neutropenic
    A Multicentric, Randomized Study to Evaluate the Safety and Efficacy of Ofloxacin versus Ofloxacin Plus Rifampin versus Norfloxacin in the Prevention of Fever and Sepsis in Patients Expected to Become Neutropenic

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 14, 1989 Closing Date: June 30, 1992



    Permanently Closed
    SC8A Double Blind Comparator Study for the Prophylactic Use of Granisetron Both Alone and in Combination With Dexamethasone Over a 7 Day Period in Controlling Nausea and Vomiting Associated With High Dose Cisplatin Therapy in Patients With Malignant Disease
    A Double Blind Comparator Study for the Prophylactic Use of Granisetron Both Alone and in Combination With Dexamethasone Over a 7 Day Period in Controlling Nausea and Vomiting Associated With High Dose Cisplatin Therapy in Patients With Malignant Disease

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 25, 1991 Closing Date: June 20, 1994



    Permanently Closed
    IC6 (46852)Empiric Antibiotic Therapy for Infection in Febrile Granulocytopenic Patients. A Prospective, Randomised Evaluation of Ceftazidime Plus Amikacin versus Ceftazidime Plus Amikacin Plus Vancomycin
    Empiric Antibiotic Therapy for Infection in Febrile Granulocytopenic Patients. A Prospective, Randomised Evaluation of Ceftazidime Plus Amikacin versus Ceftazidime Plus Amikacin Plus Vancomycin

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 01, 1986 Closing Date: December 21, 1987



    Permanently Closed
    SC4A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BrL 43694a in Comparison With High Dose Metoclopromide, Dexamethasone and Diphenhydramine in Patients Receiving Highly Emetogenic Cisplatin Chemotherapy
    A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BrL 43694a in Comparison With High Dose Metoclopromide, Dexamethasone and Diphenhydramine in Patients Receiving Highly Emetogenic Cisplatin Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 08, 1988 Closing Date: July 31, 1989



    Permanently Closed
    SC1A Comparison of Methylprednisolane Sodium Succinate and Metoclopramide Hydrochloride in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy
    A Comparison of Methylprednisolane Sodium Succinate and Metoclopramide Hydrochloride in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 30, 1982 Closing Date: March 01, 1984



    Permanently Closed
    SC11A Phase III Double-Blind Comparison of Dolasetron Mesylate With Ondansetron and an Evaluation of the Additive Role of Dexamethasone in the Prevention of Acute (IV) and Delayed (Oral) Emesis Due to Moderately Emetogenic Chemotherapy
    A Phase III Double-Blind Comparison of Dolasetron Mesylate With Ondansetron and an Evaluation of the Additive Role of Dexamethasone in the Prevention of Acute (IV) and Delayed (Oral) Emesis Due to Moderately Emetogenic Chemotherapy

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 05, 1993 Closing Date: January 27, 1995



    Permanently Closed
    SC19A Phase III Study of Ondansetron and Dexamethasone versus Ondansetron and Placebo in the Prophylaxis Against Radiation-induced Emesis
    A Phase III Study of Ondansetron and Dexamethasone versus Ondansetron and Placebo in the Prophylaxis Against Radiation-induced Emesis

    Eligibility: Patients at risk of developing radiation-induced emesis secondary to a fractionated course of radiotherapy consisting of at least 15 fractions to a field encompassing the upper abdomen.

    Objectives: To compare the effectiveness in complete protection from radiation-induced emesis and nausea using a 5-day regimen of prophylactic ondansetron and dexamethasone versus ondansetron and placebo. To compare the toxicity of the regimens and quality of life of patients in the two groups.

    NCT Registration ID (from clinicaltrials.gov): NCT00016380
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 28, 2001 Closing Date: January 31, 2004



    Permanently Closed
    SC20 (SC20)A Phase III International Randomized Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases
    A Phase III International Randomized Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases

    Complexity Level: 2

    Eligibility: Patients with painful bone metastases after previous palliative radiotherapy had been given to the diseased bone.

    Objectives: To assess the factors that influence response to re-irradiation and to determine the incidence of severe radiation side effects.

    NCT Registration ID (from clinicaltrials.gov): NCT00080912
    Participation: Not Limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 07, 2004 Closing Date: May 24, 2012



    Permanently Closed
    SC20U (SC20U)A phase III study of the effect of re-irradiation for bone pain on urinary markers of osteoclast activity.
    A phase III study of the effect of re-irradiation for bone pain on urinary markers of osteoclast activity.

    Complexity Level: 2

    Eligibility: Patients with painful bone metasteses after previous palliative radiotherapy had been given to the diseased bone.

    Objectives: To correlate the response of re-irradiation to the change of urinary markers of osteoclast activity.

    Participation: Patients randomized to SC.20 in selected centres in Canada and the United Kingdom.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 06, 2004 Closing Date: May 24, 2012



    Permanently Closed
    SC22A Phase I Study To Determine The Dose of Methadone As A First Line Agent In The Treatment of Chronic Neuropathic Cancer Pain.
    A Phase I Study To Determine The Dose of Methadone As A First Line Agent In The Treatment of Chronic Neuropathic Cancer Pain.

    Eligibility: Patients with chronic neuropathic cancer pain who need to be started on strong opioids or require an increase in their opioid dose and are currently taking opioids at a dose less than or equal to 75mg daily oral morphine equivalent.

    Objectives: To determine the optimum starting dose of methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain. To assess parameters of pain control achieved with methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain including: number and timing of BTA usage, number of episodes of breakthrough pain, total daily dose of methadone, average pain score. To determine the safety and adverse event profile of methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain. To assess the frequency and severity of sleep disturbance associated with the use of methadone. To determine the feasibility of recruiting patients with chronic neuropathic cancer pain in a reasonable time frame for a future phase III study of methadone versus morphine.

    NCT Registration ID (from clinicaltrials.gov): NCT00930332
    Participation: Limited to Canadian centres with a physician licensed to prescribe methadone.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 17, 2009 Closing Date: May 16, 2011



    Permanently Closed
    SC23A Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases.
    A Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases.

    Complexity Level: 2

    Eligibility: Cancer patients requiring treatment with radiotherapy in a single fraction of 8 Gy for bone metastases in one or two painful areas.

    Objectives: - To compare the effectiveness of prophylactic dexamethasone versus placebo in protecting against radiation-induced pain flare associated with a single 8 Gy course of treatment by examining the difference in incidence of pain flare in the first 10 days after therapy. - To compare in patients treated with dexamethasone versus placebo: the incidences of pain flare occurring on Days 0-5 and Days 6-10; the nature, severity and frequencies of adverse events; and quality of life. - To validate the EORTC QLQ-BM22 module with the EORTC QLQ-C15-PAL. - To investigate if pain flare following palliative radiotherapy is correlated with a surge of inflammatory cytokines and baseline levels of the bone turnover markers pyridinoline and N-telopeptide. - To investigate if dexamethasone prophylaxis is mediated through a decrease in inflammatory cytokines and if prophylaxis failure is due to rapid metabolism of drug, intrinsic glucocorticoid recepter defects or variations in SNPs.

    NCT Registration ID (from clinicaltrials.gov): NCT01248585
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 2010 Closing Date: December 12, 2014



    Permanently Closed