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Current Site Committee and Supportive Care Trials

Current = Active, Planned, Closed after January 01, 2002

This information is intended for use by doctors and other health care professionals. If you are a cancer patient, we recommend that you discuss this information with your doctor, who knows you, and who has the facts about your disease. If you are interested in taking part in a clinical trial, your doctor can help explain how this information may apply to you, and if this is the best treatment option in your particular case.

Last Updated: May 13, 2021

Disease Sites

BRAIN
BREAST
GASTRO-INTESTINAL
GENITO-URINARY
GYNECOLOGIC
HEAD AND NECK
HEMATOLOGIC
LUNG
MELANOMA
OTHERS
SARCOMA
SYMPTOM CONTROL

BRAIN

CE3
CE4
CE5
CE5S
CE6
CE7
CE8
CEC1
CEC2
CEC5
CEC6
CEC7

BREAST

MA17
MA17B
MA17L
MA17R
MA20
MA21
MA22
MA23
MA25
MA26
MA27
MA27B
MA27D
MA29
MA32
MA32D
MA32F
MA33
MA34
MA36
MA37
MA38
MA39
MA40
MA41
MAC2
MAC3
MAC4
MAC5
MAC6
MAC8
MAC9
MAC11
MAC12
MAC13
MAC14
MAC15
MAC18
MAC19
MAC20
MAC21
MAC22
MAC23
MAC24
MAC25
MAC26
MAC27
MAC28
MAP1
MAP2
MAP3
MAP3B
MAX1

GASTRO-INTESTINAL

BI1
CO13
CO14
CO16
CO17
CO20
CO21
CO26
CO27
CO28
CO29
CRC1
CRC2
CRC3
CRC4
CRC5
CRC6
CRC7
CRC8
CRC9
GA1
GA2
GA3
GAC1
HE1
HEC1
NEC2
NEC3
PA2
PA3
PA6
PA7
PAC1
PAC2
PAC3

GENITO-URINARY

BL7
BL8
BL10
BL11
BL13
BL13F
BLC1
BLC4
GCC1
PNC1
PR3
PR7
PR8
PR9
PR10
PR10C
PR11
PR12
PR13
PR17
PR19
PR20
PR21
PR22
PRC2
PRC3
PRC4
PRP1
PRP1B
REC1
REC2
REC3
REC4

GYNECOLOGIC

CX4
CX5
CX6
CXC1
CXC2
EN5
EN7
EN10
ENC1
GT1
OV13
OV15
OV16
OV17
OV19
OV21
OV25
OV26
OVC1
OVC2

HEAD AND NECK

HN3
HN4
HN5
HN6
HN9
HN10
HN11
HN12
HNC2

HEMATOLOGIC

AL3
AL4
AL5
AL6
ALC1
ALC2
ALC3
ALC4
ALC6
CL2
CL3
CLC1E
CLC2
CLC2E
CLC3
CM1
HD6
HD7
HD8
HD11
HD12
HDC1
LY7
LY9
LY10
LY11
LY12
LY13
LY16
LY17
LY18
LYC1
MDC1
MY7
MY10
MY11
MYC2

LUNG

BR15
BR15C
BR17
BR18
BR19
BR20
BR21
BR22
BR22C
BR23
BR23C
BR24
BR25
BR26
BR29
BR31
BR34
BR36
BRC1
BRC2
BRC2E
BRC3
BRC4
BRC5
BRC6
BRC6B
BRC6C
BRC6D
BRC6F
BRC6G
BRC6I
BRC7
BRC8

MELANOMA

ME10
ME13
ME15
MEC3
MEC5

OTHERS

PM1
PM1S

SARCOMA

SR3
SR5
SR6
SR7
SRC5
SRC6
SRC7

SYMPTOM CONTROL

IC8
ICC1
SC18
SC19
SC20
SC20U
SC22
SC23
SC24
SC26
SC27
SC28

BRAIN STUDIES

CE5

Primary Chemotherapy with Temozolomide vs. Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study.

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(EORTC)
Status: Closed
Activation Date: January 06, 2006 , Closing Date: March 28, 2013

Chairs: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2277

CE5S

Socio-behavioral Study Work, Marriage/Social Support, Anxiety and Depression NCIC CTG CE5S

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.

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Closed
Activation Date: January 22, 2007 , Closing Date: April 11, 2013

Chairs: (Canada) Dr. Anne Leis, University of Saskatchewan, 1(306) 966-7878
(Canada) Ms. Maureen Parkinson, BCCA - Vancouver Cancer Centre, 1

CE7

A Phase III Trial of Stereotactic Radiosurgery compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5-15 Brain Metastases

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

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

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

Chairs: (USA) Dr. Michael Chan, Wake Forest School of Medicine, 1(336) 713-3600
(Canada) Dr. David Roberge, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8254

CE8

A Phase III Trial of Marizomib in Combination with Standard Temozolomide-Based Radiochemotherapy versus Standard Temozolomide-Based Radiochemotherapy Alone in Patients with Newly-Diagnosed Glioblastoma

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

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

NCT Registration ID (from clinicaltrials.gov): NCT03345095
Participation: Limited to invited centres; Site Selection Open
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(EORTC)
Status: Closed
Activation Date: May 24, 2018 , Closing Date: September 17, 2020

Chairs: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2277

CEC1

Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

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(EORTC)
Status: Closed
Activation Date: July 22, 2009 , Closing Date: September 15, 2015

Chairs: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2277

CEC2

Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma

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(NCCTG)
Status: Closed
Activation Date: July 28, 2010 , Closing Date: January 14, 2015

Chairs: (Canada) Dr. Gregory Cairncross, Foothills Medical Centre, 1(403) 944-1260

CEC5

Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases

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 registrat ion.

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(ALLIANCE)
Status: Closed
Activation Date: December 23, 2016 , Closing Date: October 12, 2018

Chairs: (USA) Dr. Caroline Chung, M.D. Anderson Cancer Center, 1
(Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2277

CEC6

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

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(ALLIANCE)
Status: Open
Activation Date: March 22, 2016

Chairs: (Canada) Dr. Gregory Cairncross, Foothills Medical Centre, 1(403) 944-1260

CEC7

Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

Eligibility: This study will recruit patients 18 years or older with Karnofsky PS => 60 who have one non-CNS primary brain metastasis completely resected <= 30 days prior to registration measuring 2 cm or larger with resection cavity < 5.0 cm. At the time of screening, patients must have 3 or fewer unresected brain metastases (<4.0 cm). Patients must be able to complete an MRI of the head with contrast, have no evidence of leptomeningeal metastasis, may not have a primary germ cell tumor, small cell carcinoma, or lymphoma, and no prior whole brain radiation therapy. Past radiosurgery to other lesions is allowed, with exceptions. Brain metastasis must be located => 5 mm of the optic chiasm and outside the brainstem. No resection of more than one brain metastasis.

Objectives: The primary objective is to ascertain if time to surgical bed failure is increased with FSRS compared to SSRS in patients with resected brain metastasis. Secondary objectives include: emotional well-being at 9 months, overall survival, overall quality of life (QOL), functional independence, descriptively compare the post-treatment adverse events associated with the interventions, rates of radiation necrosis at 12 months, CNS failure patterns (local, distant brain failure, local leptomeningeal disease, widespread leptomeningeal disease), time to WBRT, emotional well-being and overall QOL in long-term survivors, time to surgical bed failure, and cognitive progression between FSRS and SSRS groups.

NCT Registration ID (from clinicaltrials.gov): NCT04114981
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ALLIANCE)
Status: Open
Activation Date: May 22, 2020

Chairs: (Canada) Dr. Jeffrey Greenspoon, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495

BREAST STUDIES

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

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: August 24, 1998 , Closing Date: September 04, 2002

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118
(USA) Dr. Hyman B. Muss, Physicians Office Building, 1(919) 966-4431
(USA) Dr. Nicholas J. Robert, , 1(703) 280-5390
(USA) Dr. Silvana Martino, John Wayne Cancer Institute, 1(310) 998-3961
(Switzerland) Dr. Monica Castiglione-Gertsch, SIAK/IBCSG Operations Office, 01141(31) 389-9191
(Belgium) Dr. Martine Piccart, Institut Jules Bordet, 01132(2) 541-3111
(USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, 1(507) 284-1887

MA17B

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: July 26, 2000 , Closing Date: August 30, 2002

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

MA17L

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: August 09, 1999 , Closing Date: May 02, 2002

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

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)

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: October 14, 2004 , Closing Date: May 08, 2009

Chairs: (Belgium) Dr. Martine Piccart, Institut Jules Bordet, 01132(2) 541-3111
(USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, 1(507) 284-1887
(USA) Dr. Nicholas J. Robert, , 1(703) 280-5390
(USA) Dr. Silvana Martino, John Wayne Cancer Institute, 1(310) 998-3961
(USA) Dr. Hyman B. Muss, Physicians Office Building, 1(919) 966-4431
(USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

MA20

A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: December 14, 1999 , Closing Date: February 02, 2007

Chairs: (Australia) Dr. Boon Chua, Prince of Wales Hospital, 01161(39) 656-1727
(USA) Dr. David Parda, Allegheny General Hospital, 1(412) 359-3400
(USA) Dr. Lori Pierce, University of Michigan Medical School, 1(734) 764-9922
(USA) Dr. Julia White, Medical College of Wisconsin, 1(215) 955-6700
(Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495
(USA) Dr. Laura A. Vallow, NCCTG Operations Office, 1(904) 953-1040

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

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: December 04, 2000 , Closing Date: April 29, 2005

Chairs: (USA) Dr. Hope Rugo, University of California, 1(415) 353-7618
(Canada) Dr. Margot Burnell, Atlantic Health Sciences Corporation, 1(506) 648-6884
(USA) Dr. Kathy S. Albain, Loyola University Medical Center, 1(708) 327-3102

MA25

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(SWOG)
Status: Closed
Activation Date: November 22, 2001 , Closing Date: June 15, 2003

Chairs: (Canada) Dr. David R. McCready, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-6510
(Canada) Dr. David R. McCready, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-6510
(Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495

MA26

Phase III Trial of Observation +/- Tamoxifen Vs. Rt +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) of The Female Breast

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(RTOG)
Status: Closed
Activation Date: January 09, 2002 , Closing Date: July 14, 2006

Chairs: (Canada) Dr. Eileen Rakovitch, Odette Cancer Centre, 1(416) 480-4974
(Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495

MA27

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: June 02, 2003 , Closing Date: July 31, 2008

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118
(USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, 1(507) 284-1887
(USA) Dr. Matthew J. Ellis, Washington University School of Medicine, 1(314) 362-8903
(USA) Dr. G. Thomas Budd, Cleveland Clinic Foundation, Desk R35, 1(216) 444-6480
(USA) Dr. George W. Sledge, Indiana Cancer Pavilion, RT-473, 1(317) 278-7576

MA27B

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: April 24, 2006 , Closing Date: May 30, 2008

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

MA27D

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(NCCTG)
Status: Closed
Activation Date: April 24, 2006 , Closing Date: July 31, 2008

Chairs: (USA) Dr. Wilma Lingle, NCCTG, Mayo Clinic, (507) 266-0954
(USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, 1(507) 284-1887
(USA) Ms. Celine M. Vachon, NCCTG, Mayo Clinic, 1(507) 284-1159
(USA) Dr. Philip J. Stella, NCCTG, Mayo Clinic, 1(507) 284-1159

MA32

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

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: Intergroup(CCTG)
Status: Closed
Activation Date: June 25, 2010 , Closing Date: January 22, 2013

Chairs: (USA) Dr. Ingrid Mayer, Vanderbilt University Medical Center, 1(615) 936-3524
(USA) Dr. Priya Rastogi, National Surgical Adjuvant Breast, 1(412) 330-4600
(UK) Prof. Judith Bliss, Institute of Cancer Research, 01144(208) 722-4297
(UK) Dr. Daniel W. Rea, Institute of Cancer Research, 01144(208) 722-4054
(Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, 1(416) 586-8605
(Switzerland) Dr. Manuela Rabaglio, IBCSG Coordinating Centre, 01141(44) 387-2550
(USA) Dr. Dawn Hershman, Herbert Irving Cancer Center, 1(212) 305-1945

MA32D

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

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(ALLIANCE)
Status: Closed
Activation Date: March 18, 2015 , Closing Date: October 13, 2017

Chairs: (Canada) Dr. Swati Kulkarni, Windsor Regional Cancer Centre, 1(519) 253-5353
(Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, 1(416) 586-8605
(Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, 1(416) 586-8605

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)

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(NSABP)
Status: Closed
Activation Date: October 28, 2011 , Closing Date: January 25, 2013

Chairs: (USA) Dr. Patricia A. Ganz, University of California at Los Angeles (UCLA), (310) 206-3566
(Canada) Dr. Julie Lemieux, CHA-Hopital Du St-Sacrement, 1(418) 649-5726

MA33

A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast

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(TROG)
Status: Closed
Activation Date: April 29, 2009 , Closing Date: June 20, 2014

Chairs: () Dr. Ivo A. Olivotto, , 1(778) 440-7322

MA36

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

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(BIG)
Status: Closed
Activation Date: July 20, 2015 , Closing Date: April 29, 2019

Chairs: (Canada) Dr. Andrea Eisen, Odette Cancer Centre, 1(416) 480-4617

MA37

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

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(BIG)
Status: Closed
Activation Date: January 25, 2017 , Closing Date: November 30, 2018

Chairs: (Canada) Dr. Julie Lemieux, CHA-Hopital Du St-Sacrement, 1(418) 649-5726

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

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
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NCIC CTG)
Status: Closed
Activation Date: December 16, 2015 , Closing Date: February 10, 2017

Chairs: (Canada) Dr. Anil A. Joy, Cross Cancer Institute, 1(780) 432-8762

MA39

Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer

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

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

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

Chairs: (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495

MA40

A Double-Blind Placebo Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor (FINER)

Eligibility: INCLUSION CRITERIA: Histologically/cytologically confirmed ER+, HER2- breast cancer. Females must be post-menopausal or pre-menopausal with ovarian supression using LHRH agonist. Clinical/radiographic progression during treatment with/within 28 days of discontinuation of 1st line treatment with CDK4/6 inhibitor and AI for advanced disease. Clinicallyradiologically documented disease. 18 years of age or older. ECOG 0 or 1. No concurrent anti-cancer therapy. Must not have received > 1 prior line of treatment with a CDK 4/6 inhibitor + AI in advanced setting. Treatment with CDK 4/6 inhibitor + AI must be most recent treatment. Adequate hematology and organ function.MAIN EXCLUSION CRITERIA: Untreated or symptomatic CNS metastases, radiation for CNS within 28 days. Active inflammatory bowel disease. Prior treatment with fulvestrant, SERDs or PI3K inhibitors. QTc>/=480 msec. Active infections. Type 1/2 diabetes requiring insulin. Hypercholesterolemia. Coagulation disorde rs.

Objectives: PRIMARY: Investigator assessed PFS (per RECIST 1.1) in ipatasertib + fulvestrant vs. placebo + fulvestrant arms SECONDARY: compare treatment arms with respect to investigator assessed PFS in PIK3CA/AKT1/PTEN altered cohort, investigator assessed PFS in non-altered PIK3CA/AKT1/PTEN cohort, PFS as assessed by blinded central radiology review in all patients, response rate (RR) [per RECIST 1.1], duration of response (DoR), clincial benefit rate (CBR), overall survival (OS), time to commencement of subsequent line systemic therapy or death (TSST), safety and tolerability (CTCAE version 5.0). quality of life (QOL) (EORTC QLQ-C30 and PRO-CTCAE), economic evaluation (EQ-5D-5L). TERTIARY: compare PFS in two treatment arms based on PIK3CA/AKT1/PTEN altered status as determined using archival tissue, identification of prognostic biomarkers, creation of a biobank of FFPE, cfDNA, and digital images, characterize pharmacokinetics

NCT Registration ID (from clinicaltrials.gov): NCT04650581
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Open
Activation Date: December 01, 2020

Chairs: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752

MA41

De-Escalation of adjuvant ChemotheRapy in HER-2 positive, EStrogen reCEptor-negative, Node-negative, early breast cancer patients who achieved pathological complete response after neoadjuvant chemotherapy and Dual HER-2 blOckade (DECRESCENDO)

Eligibility: Male or female, > or = 18 years old, ECOG 0 or 1,tumour measures 15 to 50 mm, histologically confirmed diagnosis of HER2-positive and ER-negative/PR-negative breast cancer, ER-negative/PR-negative, N0, left ventricular ejection fraction > or = 55%,

Objectives: To evaluate 3-year RFS in subjects with HER2-enriched, ER-negative/PR-negative, clinically node-negative breast cancers who achieve a pCR after neoadjuvant treatment with weekly paclitaxel (or docetaxel every 3 weeks) and dual HER2 blockade with pertuzumab and trastuzumab FDC SC. To evaluate 3-year RFS in all subjects with HER2-positive, ER-negative/PR-negative, clinically node-negative breast cancers who achieve a pCR after neoadjuvant treatment with weekly paclitaxel (or docetaxel every 3 weeks) and dual HER2 blockade with pertuzumab and trastuzumab FDC SC. To assess pCR rates in the overall population and by primary tumour dimension, 3-year RFS, Recurrence-free interval (RFI), 3-year invasive disease-free survival (iDFS), 3-year distant disease-free survival (dDFS), 3-year overall survival (OS).

Participation: Limited to invited centres; Site Selection Open
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(BIG)
Status: Planned


Chairs: (Canada) Dr. Philippe Bedard, University Health Network, 1(416) 946-4501 Ext. 4534

MAC2

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).

Eligibility:

Objectives:

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

Chairs: (Canada) Dr. Andrea Eisen, Odette Cancer Centre, 1(416) 480-4617

MAC3

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 ha ve 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(ECOG)
Status: Closed
Activation Date: June 26, 2002 , Closing Date: May 26, 2004

Chairs: (Canada) Dr. Tamara N. Shenkier, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2707

MAC8

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

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(NSABP)
Status: Closed
Activation Date: February 11, 2005 , Closing Date: November 30, 2007

Chairs: (Canada) Dr. Mark Clemons, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 70166

MAC9

Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

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(SWOG)
Status: Closed
Activation Date: July 24, 2006 , Closing Date: February 01, 2010

Chairs: (Canada) Dr. Mark Clemons, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 70166

MAC11

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.

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(SWOG)
Status: Closed
Activation Date: November 22, 2006 , Closing Date: January 15, 2012

Chairs: (Canada) Dr. Jean Latreille, Hopital Charles LeMoyne, 1(450) 466-5009

MAC12

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

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(ECOG)
Status: Closed
Activation Date: September 21, 2006 , Closing Date: October 06, 2010

Chairs: (Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, 1(416) 480-4616

MAC13

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

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(NCCTG)
Status: Closed
Activation Date: July 10, 2008 , Closing Date: August 31, 2011

Chairs: (Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, 1(416) 480-4616

MAC15

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.

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(SWOG)
Status: Closed
Activation Date: October 05, 2011 , Closing Date: October 15, 2015

Chairs: (Canada) Dr. Sukhbinder Dhesy-Thind, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Ext. 64431
(Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752

MAC18

POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy

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(ALLIANCE)
Status: Closed
Activation Date: March 16, 2016 , Closing Date: January 02, 2020

Chairs: (Canada) Dr. Ellen Warner, Odette Cancer Centre, 1(416) 480-4617

MAC19

A Randomized Phase III Trial Evalulating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

Eligibility: Please refer to the protocol for a complete list of eligibility criteria. Patients > 18 years of age. Clinical stage T1-3 N1 M0 breast cancer at Dx prior to start of neoadjuvant chemotherapy. No inflammatory breast cancer. No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix. Axillary ultrasound with FNA or core needle biopsy of axillary lymph nodes at time of diagnosis documenting axillary metastasis prior to or within 14 days of starting neoadjuvant chemotherapy. ER, PgR and HER-2 status (by IHC and/or ISH) evaluated from diagnostic core bx prior to start of neoadjuvant chemotherapy Pt must have completed at least 4 cycles of neoadjuvant chemotherapy prior to 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(ALLIANCE)
Status: Open
Activation Date: December 17, 2015

Chairs: (Canada) Dr. Steven Latosinsky, London Regional Cancer Program, 1(519) 685-8500 Ext. 58740

MAC20

Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

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(ALLIANCE)
Status: Closed
Activation Date: November 11, 2016 , Closing Date: February 15, 2021

Chairs: (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, 1(416) 586-8605
(Canada) Dr. Vanessa Bernstein, BCCA - Vancouver Island Centre, 1(250) 519-5571

MAC21

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

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

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

NCT Registration ID (from clinicaltrials.gov): NCT02927249
Participation:
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(ALLIANCE)
Status: Closed
Activation Date: September 29, 2017 , Closing Date: December 04, 2020

Chairs: (Canada) Dr. Muhammad Salim, Allan Blair Cancer Centre, 1(306) 766-2691

MAC22

Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

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
Participation:
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ECOG-ACRIN)
Status: Open
Activation Date: October 13, 2017

Chairs: (Canada) Dr. Martin Yaffe, Odette Cancer Centre, (416) 480-5715

MAC23

RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction

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

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

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

Chairs: (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495

MAC24

A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy

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

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

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

Chairs: (Canada) Dr. Christine Desbiens, CHA-Hopital Du St-Sacrement, 1(418) 682-7511

MAC25

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2 Positive Metastatic Breast Cancer

Eligibility: This study will recruit women and men =>18 with ECOG performance status 0-1 with histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease (HER 2-positive). Patients must have measurable disease based on RECIST 1.1. Adequate hematologic, hepatic and renal function within 14 days prior to randomization is required. Patients must not have cardiac disease history and history or risk of autoimmune disease.

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

NCT Registration ID (from clinicaltrials.gov): NCT03199885
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NRG)
Status: Open
Activation Date: January 08, 2020

Chairs: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752

MAC26

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

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

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

NCT Registration ID (from clinicaltrials.gov): NCT03598257
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Open
Activation Date: May 28, 2019

Chairs: (Canada) Dr. Eileen Rakovitch, Odette Cancer Centre, 1(416) 480-4974

MAC27

COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

Eligibility: Confirmed HER2-positive breast cancer, who received neoadjuvant chemotherapy, have had total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision. Must have axilla evaluated with either sentinel node biopsy or axillary lymph node dissection. Patients must have adequate hepatic, renal, and bone marrow function. Patients must not be pregnant and not nursing, must be 18 years or older (male or female), and ECOG Performance Status of 1 or less.

Objectives: The primary objective is to determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high-risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. Secondary objectives: (1) To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: overall survival (OS), breast cancer free survival (BCFS), distant recurrence-free survival (DRFS), disease-free survival (DFS), brain metastases-free survival (BMFS). (2) To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.

NCT Registration ID (from clinicaltrials.gov): NCT04457596
Participation:
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ALLIANCE)
Status: Planned


Chairs: (Canada) Dr. Phillip Blanchette, London Regional Cancer Program, 1(519) 685-8640

MAC28

Phase III Evaluating De-escalation of Breast Radiation (DEBRA) for Conservative Treatment of Stage 1, HR+, HER2 -, RS <18 Breast Cancer

Eligibility:

Objectives:

Participation:
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(NRG)
Status: Planned


Chairs: (Canada) Dr. Valerie Theberge, CHUQ-Pavillon Hotel-Dieu de Quebec, 1(418) 691-5264

MAP1

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
Status: Closed
Activation Date: December 05, 2000 , Closing Date: June 09, 2006

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

MAP2

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
Status: Closed
Activation Date: August 01, 2001 , Closing Date: June 09, 2006

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

MAP3

A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

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
Status: Closed
Activation Date: February 11, 2004 , Closing Date: March 23, 2010

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

MAP3B

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

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
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Closed
Activation Date: January 23, 2008 , Closing Date: March 23, 2010

Chairs: (USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

GASTRO-INTESTINAL STUDIES

CO21

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).

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: Intergroup(NCIC CTG)
Status: Open
Activation Date: December 03, 2008

Chairs: (Australia) Dr. Janette Vardy, Sydney Cancer Centre, 01161(29) 767-6345
(Canada) Dr. Chris Booth, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 4505
(Australia) Dr. Janette Vardy, Sydney Cancer Centre, 01161(29) 767-6345
(Canada) Dr. Kerry Courneya, University of Alberta, 1(780) 492-1031

CO26

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

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: Intergroup(CCTG)
Status: Closed
Activation Date: August 10, 2016 , Closing Date: June 29, 2017

Chairs: (Canada) Dr. Eric (Xueyu) Chen, University Health Network, 1(416) 946-2263

CO27

A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting

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(UNICANC)
Status: Open
Activation Date: May 02, 2017

Chairs: (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2734

CO28

NEOadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The NEO Trial

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: Intergroup(CCTG)
Status: Closed
Activation Date: August 22, 2017 , Closing Date: May 19, 2020

Chairs: (Canada) Dr. Carl Brown, St. Paul's Hospital, (604) 806-8711

CO29

Circulating Tumor DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC III)

Eligibility: - Patients aged >=18 years of age - Subjects with curatively resected stage III (Any T, N1 or N2, M0) colorectal cancer - Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients must have had TME type surgery with negative (R0) resection margins. - A representative tumour sample is available for molecular testing up to 6 weeks after surgery (refer to section 9.1.1 for a more specific timeframe) - Fit for at least single agent fluoropyrimidine adjuvant chemotherapy - ECOG performance status 0-2 - No metastatic disease

Objectives: Primary objective: To evaluate the impact of a de-escalation/escalation treatment strategy using ctDNA-informed management. The ctDNA positive and negative cohorts will be evaluated separately: (a) For ctDNA negative patients: de-escalation treatment strategy is non-inferior to standard of care (b) For the ctDNA positive patients: escalation treatment strategy is superior to standard of care. Secondary objectives: To demonstrate (1) ctDNA-informed adjuvant therapy approach will not compromise RFS in patients with NEGATIVE post-op ctDNA; (2) an acceptable rate of de-escalation in the ctDNA-informed negative cohort; (3) 3-year RFS rates between ctDNA-informed therapy and standard of care in patients with POSITIVE post-op ctDNA; (4) OS between ctDNA-informed therapy and standard of care in patients with POS & NEG post-op ctDNA; (5) end of treatment ctDNA results with RFS and OS; (6) feasibility of adjuvant chemo strategy based on post-op ctDNA results; (7) Heath economic impact

Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(AGITG)
Status: Open
Activation Date: February 09, 2021

Chairs: (Canada) Dr. Jonathan Loree, BCCA - Vancouver Cancer Centre, (604) 877-6000

CRC3

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

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(ECOG)
Status: Closed
Activation Date: April 27, 2006 , Closing Date: February 11, 2011

Chairs: (Canada) Dr. Sheryl Koski, Cross Cancer Institute, 1(780) 432-8513

CRC6

A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo For Patients With Resected Stage III Colon Cancer

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(ALLIANCE)
Status: Closed
Activation Date: March 28, 2011 , Closing Date: November 20, 2015

Chairs: (Canada) Dr. Felix Couture, CHUQ - Hotel-Dieu de Quebec, 1(418) 691-5225

CRC7

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)

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(ALLIANCE)
Status: Closed
Activation Date: October 17, 2012 , Closing Date: December 28, 2018

Chairs: (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 72791

CRC8

A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer

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

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

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

Chairs: (Canada) Dr. Michael Vickers, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 70185

CRC9

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomarRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

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

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

NCT Registration ID (from clinicaltrials.gov): NCT04068103
Participation:
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NRG)
Status: Open
Activation Date: April 21, 2020

Chairs: (Canada) Dr. Howard Lim, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672699

GA1

A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)

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(TROG)
Status: Open
Activation Date: July 31, 2013

Chairs: (Canada) Dr. Rebecca Wong, University Health Network, 1(416) 946-2126

GA3

A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

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(AGITG)
Status: Closed
Activation Date: January 09, 2017 , Closing Date: February 03, 2021

Chairs: (Canada) Dr. Thierry Alcindor, The Research Institute of the McGill University, 1(514) 934-1934 Ext. 43118

HE1

Phase III Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases

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
Status: Open
Activation Date: July 23, 2015

Chairs: (Canada) Dr. Laura Ann Dawson, University Health Network, 1(416) 946-2125

NEC3

Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors

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(ALLIANCE)
Status: Closed
Activation Date: February 28, 2014 , Closing Date: October 07, 2016

Chairs: (Canada) Dr. Tim Asmis, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 79556

PA6

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

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(UNICANC)
Status: Closed
Activation Date: July 17, 2012 , Closing Date: September 07, 2016

Chairs: (USA) Dr. Alice C. Wei, Memorial Sloan Kettering Cancer Center, 1
(Canada) Dr. James Biagi, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 4503

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

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: Intergroup(CCTG)
Status: Closed
Activation Date: August 22, 2016 , Closing Date: July 26, 2018

Chairs: (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672357

PAC1

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

Objectives:

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

Chairs: (Canada) Dr. Ralph P.W. Wong, CancerCare Manitoba, St. Boniface General Hospital, 1(204) 235-3044

PAC2

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

Eligibility:

Objectives:

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

Chairs: (Canada) Dr. James Biagi, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 4503

PAC3

Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

Eligibility: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma, TNM Stage: Tx-4, N0-1, M0 Local radiographic reading consistent with resectable disease Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio Determined to be appropriate candidate for curative-intent pancreatectomy No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy or surgery for pancreatic cancer Not pregnant and not nursing Age > or = to 18 years ECOG Performance Status 0-1 Total Neuropathy Score < 2 No known Gilbert's Syndrome or known homozygosity for UGATA1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors and/or inducers of CYP3A4 is not allowed Measurable disease and/or non-measurable disease

Objectives: The primary objective of this study is to evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma (PDAC) treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

NCT Registration ID (from clinicaltrials.gov): NCT04340141
Participation:
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ALLIANCE)
Status: Open
Activation Date: May 03, 2021

Chairs: (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672357

GENITO-URINARY STUDIES

BL13

A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer

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

Objectives: The overall objective of this phase II randomized trial is to determine if Durvalumab when used in combination following standard trimodality therapy improves disease-free-survival when compared to surveillance alone in patients with T2 or more muscle-invasive bladder cancer.

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

Chairs: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, 1(514) 934-8246

BL13F

Electronic 'Real-Time' Patient Self-Reporting of Immunotherapy Symptomatic Adverse Events using the SYMPTOM-IQ Tool on the uMotif Mobile Health Application (APP): A Prospective Feasibility Sub-Study of BL13 [e-PRISM]

Eligibility: Participants on both arms of the main BL.13 study are eligible for the BL.13F sub-study. Participants must be willing to complete symptom reports on a mobile phone application in English or French.

Objectives: To assess feasibility (recruitment, retention, adherance) and acceptability of remote patient self-reporting of ten common symptomatic immune-related adverse events, using the uMotif mobile phone application.

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Open
Activation Date: July 15, 2020

Chairs: (Canada) Dr. Doris Howell, University Health Network, 1(416) 946-4501 Ext. 3419

BLC1

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

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(SWOG)
Status: Closed
Activation Date: January 15, 2014 , Closing Date: February 15, 2017

Chairs: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, 1(514) 934-8246

BLC4

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer

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

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

NCT Registration ID (from clinicaltrials.gov): NCT02844816
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: April 07, 2017 , Closing Date: July 05, 2019

Chairs: (Canada) Dr. Peter Black, Clinical Research Unit at Vancouver Coastal, 1(604) 875-5003
(Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, 1(514) 934-8246

GCC1

A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumours

Eligibility: Male or female patients must have a new diagnosis of a germ cell tumor. If surgery is planned, male patients with CSI Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration. All primary sites, stages, histological subtypes of germ cell tumor and metachronous secondary germ cell tumors are eligible. Patients must be registered within 42 days after diagnosis and prior to initiation of a management plan or treatment for the disease. Additionally, within 42 days prior to registration, patients must: have initial imaging, laboratory and other clinical evaluations performed as defined in the protocol and have beta-human chorionic gonadotropin (beta- HCG), alpha-fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments. Finally patients must: be >/= 18 years of age, have risk of relapse assessment determined by the local investigator prior to registration and agree to submit required specimens for defined translation al medicine studies.

Objectives: Primary Objective To estimate the positive predictive value within each of the early stage seminoma and non-seminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy. Secondary Objectives a. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data. b. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531.

NCT Registration ID (from clinicaltrials.gov): NCT04435756
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(SWOG)
Status: Open
Activation Date: August 27, 2020

Chairs: (Canada) Dr. Lucia Nappi, BCCA - Vancouver Cancer Centre, (604) 877-6000

PNC1

InPACT: International Penile Advanced Cancer Trial

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

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

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

Chairs: (Canada) Dr. Juanita Crook, BCCA - Cancer Centre for the Southern Interior, 1(250) 712-3900 Ext. 3979

PR3

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: February 08, 1995 , Closing Date: August 31, 2005

Chairs: (USA) Dr. Srinivasan Vijayakumar, The University of Chicago Medical Center, 1(312) 791-2514
(USA) Dr. Richard Whittington, Veteran's Hospital, 1(215) 823-5855
(Canada) Dr. Padraig Warde, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 2122
(USA) Dr. George Wilding, Univ. of WI Comprehensive Can Ctr., 1(608) 263-0209

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

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: January 05, 1999 , Closing Date: November 30, 2005

Chairs: (Canada) Dr. Juanita Crook, BCCA - Cancer Centre for the Southern Interior, 1(250) 712-3900 Ext. 3979
(USA) Dr. Celestia S. Higano, University of Washington, 1(206) 548-4518
(Canada) Dr. Laurence Klotz, Odette Cancer Centre, 1(416) 480-4673
(UK) Dr. David Dearnaley, Royal Marsden Hospital, 01144(20) 8661-3271
(USA) Dr. Eric Horwitz, Fox Chase Cancer Centre, 1(215) 728-2995

PR9

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(RTOG)
Status: Closed
Activation Date: February 25, 2004 , Closing Date: May 07, 2004

Chairs: (Canada) Dr. Laurence Klotz, Odette Cancer Centre, 1(416) 480-4673

PR10

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(ACOSOG)
Status: Closed
Activation Date: February 19, 2002 , Closing Date: April 09, 2004

Chairs: (Canada) Dr. Neil Fleshner, University Health Network, 1(416) 946-4501 Ext. 2899
(Canada) Dr. Neil Fleshner, University Health Network, 1(416) 946-4501 Ext. 2899

PR10C

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(ACOSOG)
Status: Closed
Activation Date: September 19, 2003 , Closing Date: April 09, 2004

Chairs: (Canada) Dr. Neil Fleshner, University Health Network, 1(416) 946-4501 Ext. 2899

PR11

A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: June 15, 2007 , Closing Date: May 13, 2011

Chairs: (USA) Dr. Adam S. Kibel, Washington University School of Medicine, 1(314) 362-8295
(Canada) Dr. Laurence Klotz, Odette Cancer Centre, 1(416) 480-4673

PR12

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
Status: Closed
Activation Date: March 03, 2008 , Closing Date: November 12, 2009

Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746
(Canada) Dr. Michael McKenzie, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2380

PR13

RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery.

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(MRC)
Status: Closed
Activation Date: September 27, 2007 , Closing Date: December 30, 2016

Chairs: (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8000 Ext. 27466
(Canada) Dr. Charles Catton, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 2121

PR17

Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

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(ANZUP)
Status: Closed
Activation Date: February 02, 2015 , Closing Date: March 24, 2017

Chairs: (Canada) Dr. Scott North, Cross Cancer Institute, 1(780) 432-8762

PR19

A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

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, PSA progression, PSA nadir, local disease progression, regional disease progression, regional disease progression, distant disease progression, 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: Intergroup(CCTG)
Status: Open
Activation Date: November 04, 2016

Chairs: (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, 1(418) 691-5264
(Canada) Dr. Gerard Morton, Odette Cancer Centre, 1(416) 480-6165

PR20

A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]

Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven oligometstatic adenocarcinoma of the prostate and no evidence of small cell cancer,(3) Stage: IV (newly diagnosed at presentation or relapse after curative intent therapy); M1 dx less than/= to 5 mets; N1 disease can be included as site of metastases only in patients in relapse after curative intent prostate surgery or radiotherapy (4) Less than/= 3 mets in any non-bone organ system (5) All patients must receive Zoladex (LHRHa),(6)all tumours must be amenable to local ablative therapy (Radiation or surgery),(7) ECOG PS 0-1, (8)patient is medically suitable for all treatment options. EXCLUSION: prior adj/neoadj ADT, unless stopped >12 months & 36 mo. max duration; recurrent/metstatic disease previously treated with systemic or radiation therapy; Castration resistant prostate cancer (per PCWG3); Untreated pelvic lymph nodes as only site of disease; inability to treat all sites of disease with LAT; parenchym al brain mets.

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

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

Chairs: (Canada) Dr. Patrick C.F. Cheung, Odette Cancer Centre, 1(416) 480-6165
(Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, 1(514) 340-8288

PR21

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

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

Objectives: (Primary): To compare radiographic progression-free survival (rPFS) of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA radioligand therapy vs. docetaxel in the post androgen receptor (AR)-targeted therapy setting. (Secondary): Second rPFS in patients who meet criteria for rPFS and crossover to the alternate therapy (Secondary):Time to commencement of third line therapy (Secondary): Overall survival (Secondary):proportion of patients with decreased PSA from baseline and the magnitude of change (Secondary):Clinical benefit rate (CBR) and response duration including partial response (PR), complete response (CR) or stable disease > 24 weeks (Secondary): Determine adverse event (AE) profile (Secondary): Patient reported QOL (Secondary): Cost-effectiveness (Tertiary): explore biomarkers of response and resistance using cell free DNA (Tertiary): retrospectively explore a dosimetry-based approach to determine administered activity.

NCT Registration ID (from clinicaltrials.gov): NCT04663997
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Open
Activation Date: December 17, 2020

Chairs: (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8000 Ext. 27466
(Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746
(Canada) Dr. Francois Benard, BCCA - Vancouver Cancer Centre, (604) 675-8206

PR22

DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate. A Randomized Phase III Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localized Prostate Cancer

Eligibility: Men with either very high risk localised prostate cancer or very high risk features with PSA persistence/rise within 12 months following radical prostatectomy, suitable for EBRT with or without brachytherapy. CT/MRI and bone scan negative for distant metastases (allow pelvic LN).

Objectives: Primary: Metastasis-free survival Secondary: Overall survival; prostate cancer-specific survival; PSA-progression free surival; time to subsequent hormonal therapy; time to castration-resistance; frequency and esverity of adverse events; health-related QoL; fear of cancder recurrence Tertiary: Incremental cost-effectiveness; prognostic/predictive biomarkers

NCT Registration ID (from clinicaltrials.gov): NCT04136353
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(ANZUP)
Status: Open
Activation Date: November 27, 2020

Chairs: (Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, 1(514) 340-8288

PRC2

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

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(CALGB)
Status: Closed
Activation Date: February 07, 2006 , Closing Date: April 02, 2012

Chairs: (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8000 Ext. 27466

PRC3

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.

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(ALLIANCE)
Status: Closed
Activation Date: October 15, 2007 , Closing Date: October 02, 2015

Chairs: (Canada) Dr. Martin E. Gleave, Clinical Research Unit at Vancouver Coastal, 1(604) 875-4111

PRC4

Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

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(ALLIANCE)
Status: Closed
Activation Date: October 27, 2014 , Closing Date: August 31, 2016

Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746

PRP1

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
Status: Closed
Activation Date: November 28, 2001 , Closing Date: July 23, 2004

Chairs: (Canada) Dr. Neil Fleshner, University Health Network, 1(416) 946-4501 Ext. 2899

PRP1B

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.

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to subjects enrolled on the PRP.1 study.
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Closed
Activation Date: July 29, 2005 , Closing Date: April 17, 2009

Chairs: (Canada) Dr. Neil Fleshner, University Health Network, 1(416) 946-4501 Ext. 2899

REC2

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

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(ECOG)
Status: Closed
Activation Date: September 14, 2006 , Closing Date: September 02, 2010

Chairs: (Canada) Dr. Lori Wood, QEII Health Sciences Centre, 1(902) 473-6106
(Canada) Dr. Michael A.S. Jewett, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2909

REC3

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)

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(SWOG)
Status: Closed
Activation Date: July 27, 2016 , Closing Date: December 15, 2019

Chairs: (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, 1(403) 521-3166

REC4

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

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

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

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

Chairs: (Canada) Dr. Anil Kapoor, St. Joseph's Healthcare Charlton Campus, 1(905) 522-1155 Ext. 33218
(Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, 1(403) 521-3166

GYNECOLOGIC STUDIES

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)

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: August 02, 2012 , Closing Date: November 29, 2019

Chairs: (The Netherlands) Dr. Cor de Kroon, The Dutch Gynecological Oncology Group (DGOG), 01131(61) 540-8037
(Canada) Dr. Marie Plante, CHUQ - Hotel-Dieu de Quebec, 1(418) 691-5392

CX6

International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer SENTICOL III

Eligibility: - With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy), - Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), - Maximum diameter . 40 mm by clinical examination and/or magnetic resonance imaging (MRI), - No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1),

Objectives: - To assess that Disease Free Survival (DFS) is similar between pN0 patients after SLN biopsy versus SLN biopsy + PLN - To assess a superiority of SLN biopsy for quality of life (HR-QoL)

NCT Registration ID (from clinicaltrials.gov): NCT03386734
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(GINECO)
Status: Open
Activation Date: July 24, 2020

Chairs: (Canada) Dr. Vanessa Samouelian, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8444

CXC2

A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Eligibility: Patient has a new, untreated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone. The presence or absence of para-aortic lymph node metastasis will be based on pre-therapy (18)F FDG PET/CT. NOTE: If the baseline (18)F FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible. The patient must be able to tolerate imaging requirements of an (18)F FDG PET/CT scan.

Objectives: Primary Objective:To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase overall survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer. Secondary Objective: To determine the relative progression-free survival impact of triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy.

NCT Registration ID (from clinicaltrials.gov): NCT02466971
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NRG)
Status: Open
Activation Date: April 30, 2021

Chairs: (Canada) Dr. Eric Leung, Odette Cancer Centre, 1(416) 480-5000 Ext. 6165

EN7

Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.

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(DCGOG)
Status: Closed
Activation Date: September 03, 2008 , Closing Date: December 20, 2013

Chairs: (The Netherlands) Dr. Carien L. Creutzberg, The Dutch Gynecological Oncology Group (DGOG), 01131(71) 526-3052
(Canada) Dr. Paul Bessette, Centre hospitalier universitaire de Sherbrooke, 1(819) 346-1110 Ext. 13120
(Canada) Dr. Anthony Fyles, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-6522

EN10

Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype/NSMP Early Stage Endometrial Cancer (TAPER)

Eligibility:

Objectives:

Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Planned


Chairs: (Canada) Dr. Jessica McAlpine, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2395

ENC1

A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC#776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

Eligibility: women with measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.

Objectives: Primary Objective: To evaluate the efficacy of pembrolizumab in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer. Efficacy will be determined via investigator assessed progression free survival (PFS) in two distinct populations referred to as proficient and deficient mismatch repair (pMMR and dMMR).

NCT Registration ID (from clinicaltrials.gov): NCT03914612
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NRG)
Status: Open
Activation Date: October 29, 2019

Chairs: (Canada) Dr. Stephen Welch, London Regional Cancer Program, 1(519) 685-8640

OV13

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

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(EORTC)
Status: Closed
Activation Date: May 13, 1999 , Closing Date: November 30, 2006

Chairs: (Canada) Dr. Gavin Stuart, University of British Columbia, 1(604) 822-5767
(Canada) Dr. Gavin Stuart, University of British Columbia, 1(604) 822-5767

OV15

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(AGO)
Status: Closed
Activation Date: October 17, 2000 , Closing Date: April 15, 2002

Chairs: (Germany) Dr. Jacobus Pfisterer, Staedtisches Klinikum Solingen, 01149(212) 547-2371
(Canada) Dr. Marie Plante, CHUQ - Hotel-Dieu de Quebec, 1(418) 691-5392

OV17

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

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(GINECO)
Status: Closed
Activation Date: October 17, 2005 , Closing Date: September 25, 2007

Chairs: (France) Dr. Eric Pujade-Lauraine, Hopital Hotel Dieu, 01133(1) 4234-8325

OV19

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.

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(MRC)
Status: Closed
Activation Date: March 19, 2007 , Closing Date: February 13, 2009

Chairs: (Canada) Dr. Mark S. Carey, Clinical Research Unit at Vancouver Coastal, 1(604) 877-6000
(Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2818
(UK) Dr. Timothy Perren, St. James University Hospital, 01144(113) 206-6927

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.

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: September 11, 2009 , Closing Date: May 27, 2015

Chairs: (Canada) Dr. Helen MacKay, Odette Cancer Centre, 1(416) 480-5145
(USA) Dr. Deborah Kay Armstrong, Southwest Oncology Group, Operations Office, 1(410) 614-2743
(UK) Dr. Chris Gallagher, UCL Cancer Trials Centre, 01144
(Spain) Ms. Ana Oaknin-Benzaquen, GEICO-Sociedad Espanola de Oncologia Medica (SEOM), 01134
(Canada) Dr. Diane Provencher, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8444

OV25

A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs)

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

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

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

Chairs: (Canada) Dr. Stephanie Lheureux, University Health Network, 1(416) 946-4501 Ext. 2415
(Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2818

OV26

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

Eligibility: Histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with second-line platinum-based chemotherapy. CT or MRI proven relapsed disease at first recurrence (measurable or non-measurable) prior to starting second-line treatment or surgically debulking. Completed a minimum of 4 cycles of platinum-based chemotherapy for first relapse (2nd line treatment)

Objectives: I. Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) II. Overall survival measured from the date of randomisation to the date of death from any cause I. Toxicity II. Adherence to maintenance therapy- compliance and dose reductions and interruptions III. PFS and OS measured from the start of second-line chemotherapy IV. TSST (the time from randomisation to start of second subsequent treatment or death) V. Quality of Life using EORTC QLQC30 and OV28 VI. Cost effectiveness using EQ-5D-5L for economic evaluation VII. Progression free survival by CA125 - GCIG criteria VIII. Response rate (RECIST v1.1 and/or CA125) at 16 weeks of treatment in patients who had RECIST v1.1 measurable disease or elevated CA125 at randomisation. RECIST measurements will be based on investigator assessment not central review

NCT Registration ID (from clinicaltrials.gov): NCT03278717
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(UCLCTU)
Status: Open
Activation Date: November 26, 2020

Chairs: (Canada) Dr. Helen MacKay, Odette Cancer Centre, 1(416) 480-5145

OVC1

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

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(NRG)
Status: Closed
Activation Date: January 04, 2017 , Closing Date: November 10, 2017

Chairs: (Canada) Dr. Helen MacKay, Odette Cancer Centre, 1(416) 480-5145

OVC2

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)

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(NRG)
Status: Closed
Activation Date: January 19, 2017 , Closing Date: October 02, 2020

Chairs: (Canada) Dr. Diane Provencher, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8444

HEAD AND NECK STUDIES

HN9

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)

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 N1 (smoking >10 pack-years) - T3 N0-N1 (smoking >10 pack-years) - T1-3 N2 (any smoking history) 2) Human papillomavirus (HPV)-related as determined by positive p16 immunohistochemical staining on any tumoural specimens. 3) Performance status of 0 or 1. 4) > 18 years of age. 5) Patient must consent to release of tumour tissue, blood, saliva and throat swab samples for correlative studies. 6) Adequate normal organ and marrow function.

Objectives: Primary: To estimate the efficacy (in terms of event-free survival) of 3 treatment Arms: (A) radiotherapy (RT) and cisplatin; (B) RT and durvalumab followed by adjuvant durvalumab; and (C) RT and durvalumab followed by adjuvant durvalumab and tremelimumab in patients with intermediate risk, HPV-positive, locally advanced oropharyngeal squamous cell carcinoma of the head and neck (LA-OSCC). Secondary: 1) To assess differences between arms in change in FACT-HN score from baseline to 36 months post-RT; 2) To estimate and describe the following in each of the 3 treatment arms: Locoregional control; Distant metastasis-free survival (DMFS); OS; Toxicity; Incidence of second cancer; Dysphagia; PRO-CTCAE Radiation related late toxicity; Cost effectiveness; Cost utility; and lost productivity. Tertiary: 1) Correlative Studies; 2) Event-free survival as defined by iRECIST.

NCT Registration ID (from clinicaltrials.gov): NCT03410615
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(CCTG)
Status: Open
Activation Date: January 31, 2018

Chairs: (Canada) Dr. Anna Spreafico, University Health Network, 1(416) 946-4501 Ext. 4012
(Canada) Dr. Khalil Sultanem, The Jewish General Hospital, 1(514) 340-8288

HN10

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

Eligibility: Patients with pathologically proven diagnosis of HPV-related OPSCC. Clinical stage T1-3 N0-1 M0. Patients must be eligible for definitive RT or CRT, >= 18 years of age, ECOG 0-2. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. Patients must be accessible for treatment and follow up.

Objectives: Primary Objective: To evaluate the efficacy of primary definitive radiotherapy (RT) or chemoradiotherapy (CRT) utilizing volume reduced elective nodal irradiation (ENI) as measured by 2-year progression-free survival (PFS) in patients with low-risk HPV-related OPSCC. Secondary Objectives: To evaluate other metrics for efficacy and safety, early and late toxicities of treatment, objective swallowing and salivary functions, quality of life (QOL), utilization of healthcare resources, work productivity, and prognostic biomarkers. Tertiary Objectives: To assemble an imaging and biospecimen bank for future research that could improve risk stratification and patient selection for volume-reduced ENI.

NCT Registration ID (from clinicaltrials.gov): NCT03822897
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(CCTG)
Status: Open
Activation Date: February 20, 2019

Chairs: (Canada) Dr. Scott Bratman, University Health Network, (416) 946-4501
(Canada) Dr. Kathy Han, University Health Network, 1(416) 946-4501 Ext. 2919

HN11

SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer (SELECT): A Phase III Randomized Controlled Trial

Eligibility:

Objectives:

Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Planned


Chairs: (Canada) Dr. Ali Hosni Abdalaty, University Health Network, (416) 946-4501 Ext. 2126
(Canada) Dr. John de Almeida, University Health Network, 1(416) 946-4501

HN12

PROMOTE-HN PembROlizumab with or without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma

Eligibility:

Objectives:

Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Planned


Chairs: (Canada) Dr. Anna Spreafico, University Health Network, 1(416) 946-4501 Ext. 4012

HNC2

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

Eligibility: Eligibility Criteria include: p16 and PD-L1 status by submission of tissue samples, pathologically confirmed, previously untreated, unresected squamous cell carcinoma of larynx, hypopharynx, oropharynx, oral cavity or unknown head and neck primary within 60 days of registration (locoregionally advanced HNSCC), contraindication to cisplatin, adequate hematological hepatic and renal function, negative pregnancy test (if applicable)

Objectives: Phase II: Primary objective is PFS. Phase III: Primary objective is OS. Secondary objectives include: Toxicity profile, effects of anti-PD-L1 therapy, OS, response, loco-regional failure, distant metastasis, and competing mortality, Quality of Life, swallowing related QoL and performance, gastronomy tube retention Exploratory objectives include: immune response, short term QoL, short term swallowing related QoL, patient reported fatigue, and health utilities

NCT Registration ID (from clinicaltrials.gov): NCT03258554
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NRG)
Status: Open
Activation Date: May 10, 2019

Chairs: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, 1(519) 685-8261

HEMATOLOGIC STUDIES

AL5

Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial

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(DFCI)
Status: Closed
Activation Date: September 10, 2008 , Closing Date: January 08, 2013

Chairs: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, 1(514) 252-3400 Ext. 3404

AL6

A Measurable Residual Disease (MRD) Driven, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients with AML

Eligibility:

Objectives:

Participation:
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Planned


Chairs: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, 1(514) 340-8207
(Canada) Dr. Mary Lynn Savoie, Tom Baker Cancer Centre, 1(403) 944-1564

ALC2

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).

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(CALGB)
Status: Closed
Activation Date: April 21, 2009 , Closing Date: October 14, 2011

Chairs: (Canada) Dr. Joseph Brandwein, University of Alberta Hospital (UAH), 1(780) 407-7482

ALC3

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)

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(SWOG)
Status: Closed
Activation Date: September 10, 2013 , Closing Date: November 04, 2015

Chairs: (Canada) Dr. Mary Lynn Savoie, Tom Baker Cancer Centre, 1(403) 944-1564

ALC4

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.

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(ECOG)
Status: Closed
Activation Date: March 24, 2017 , Closing Date: October 15, 2019

Chairs: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, 1(514) 252-3400 Ext. 3404

ALC6

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (A Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL

Eligibility: Patients who are 18 to 39 years old and are newly diagnosed with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible for this study. Patients with Burkitt type ALL or who have BCR-ABL fusion transcript determined by FISH or RT-PCR or t(9;22)(q34;q11) by cytogenetics are not eligible. No prior therapy is allowed for ALL except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. Patients must complete remission induction therapy and have M2 marrow or better by the time of randomization.

Objectives: To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS), without censoring for transplant. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response.To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved, with censoring for transplant.To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.To determine the prognosis based on patients' LDA gene signature. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the regimen used in CALGB 10403.

NCT Registration ID (from clinicaltrials.gov): NCT03150693
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(ALLIANCE)
Status: Open
Activation Date: April 12, 2019

Chairs: (Canada) Dr. Matthew D. Seftel, Clinical Research Unit at Vancouver Coastal, 1

CLC1E

A Canadian Economic Analysis of CLC.1

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): no NCT
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(NCIC CTG)
Status: Closed
Activation Date: July 13, 2009 , Closing Date: December 24, 2009

Chairs: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, 1(416) 480-5000 Ext. 4757

CLC2

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).

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(ALLIANCE)
Status: Closed
Activation Date: February 05, 2015 , Closing Date: May 01, 2016

Chairs: (Canada) Dr. Carolyn Owen, Tom Baker Cancer Centre, 1(403) 521-3621

CLC2E

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

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
Status: Closed
Activation Date: March 13, 2015 , Closing Date: May 01, 2016

Chairs: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, 1(416) 480-5000 Ext. 4757

CLC3

Randomized Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus DeLayed Therapy with VEnetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Eligibility: Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) diagnosed withing 12 months prior to registration. Must have CLL-International Prognostic Index Score greater or equal to 4 and/or complex cytogenics. Cytogenic and FISH analyses within 12 months prior to registration. TP53 mutation status if done completed wihtin 12 months prior to registration. IgVH status obtained prior to registration. Serum beta-2 microglobulin level obtainted within 28 days prior to registration. Must not meed any of the IWCLL specified criteria for active CLL therapy.

Objectives: Primary: To evaluate whether early treatment with venetoclax and obinutuzumab (V-O) extends overall survival (OS) compared with delayed treatment with V-O in high-risk (chronic lymphocytic leukemia [CLL] international prognostic indicator [CLL-IPI] .4 or complex cytogenetics), newly diagnosed asymptomatic CLL/SLL patients. Secondary: Compare overall reponse reated between arms. To evaluate saftey and tolerability of each arm. To compare time to second CLL-directed treatment between arms. To compare relapse-free survival (RFS) and time to second objective disease response. To compare rates of Richter's transformation between arms. To describe Cumulative Illness Rating Scale across the study, in each treatment arm and to estimte the interation betrween the scale and treatment and OS. Teritary: To assess impact of early intervention with V-O versus delayed therapy with V-O in CLL patients to HRQoL using FACT-Leukemia. Additional correlative objectives

NCT Registration ID (from clinicaltrials.gov): NCT04269902
Participation: Limited to invited centres; Site Selection Open
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Planned


Chairs: (Canada) Dr. Versha Banerji, CancerCare Manitoba, 1(204) 787-4904

HD8

BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma

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(EORTC)
Status: Closed
Activation Date: May 13, 2003 , Closing Date: January 08, 2010

Chairs: (Canada) Dr. Ralph Meyer, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9711 Ext. 63004

HD11

A Randomized Phase II Trial of Pembrolizumab and Brentuximab Vedotin versus GDP Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma

Eligibility: Patients 18 years and up must have had a history of classic Hodgkin lymphoma by histopathology and have relapsed or refractory disease after anthracycline-containing chemotherapy. Patients must have ECOG performance of 0-1 and are eligible for high dose chemotherapy and autologous stem cell transplant. No prior salvage systemic therapy for relapsed/refractory disease. No history of peripheral neuropathy or dyspnea > grade 2, active CNS disease, cerebral vascular event, progressive multifocal leukoencephalopathy (PML), (non-infectious) pneumonitis requiring steroids, HIV, nor other malignancies (with exceptions). No diagnosis of immunodeficiency, no active autoimmune disease requiring treatment in past 3 years. No active Hepatitis C or B infection or any uncontrolled active systemic infection. No clinically significant cardiovascular disease. Any serious active disease or co-morbid medical condition. No live vaccination. No allogenic tissue/solid organ transplant. No RT within 14 days.

Objectives: Primary:To determine the complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy. Secondary: PFS, EFS, OS, successful stem cell collection rate, transplantation rate, toxicity and safety, patient reported quality of life, health economics including patient reported financial toxicity and cost per quality adjusted life years Exploratory: To identify markers of disease response and/or tumour biology that provide prognostic or predictive information, to evaluate PET radiomic parameters beyond those identified in the Lugano 2014 response criteria, and to evaluate response and outcome using the RECIL criteria

Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Planned


Chairs: (Canada) Dr. John Kuruvilla, University Health Network, 1(416) 946-2827
(Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2641

HD12

A Randomized Phase III Trial with a PET Response Adapted Design Comparing ABVD +/- ISRT with A2VD +/- ISRT in Patients with Previously Treated Stage IA/IIA Hodgkin Lymphoma (RADAR)

Eligibility: Patients, 16-69 years old, may be enrolled in this study if they have histologically confirmed stage I or II classical Hodgkin lymphoma with no mediastinal bulk disease or B symptoms. Patients must have ECOG status of 0 to 2.Patients must not have received prior treatment for Hodgkin lymphoma, but should be fit to receive anthracycline-based chemotherapy. Patient must have the following lab values: creatinine clearance >40 ml/min, total bilirubin <1.5 x ULN, ALT or AST <2 x ULN, haemoglobin > or equal to 8g/dL, neutrophils > or equal to 1.0 x109/l, and platelets > or equal to 100 x109/l. Patients are excluded if they have nodular lymphocyte Hodgkin lymphoma, other cancer diagnosed within last 5 years with exceptions, or recurrent of persistent other cancer within last 5 years. Patients are excluded if there is an absence of FDG-avid lymphoma lesions on baseline PET scan, or they have a pre-existing grade > or equal to 1 sensory or motor peripheral neuropathy.
< BR> Objectives:

Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(NCRI(UK))
Status: Planned


Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567

HDC1

A Phase III Randomized Study of Nivolumab (Opdivo) or Brentuximab Vedotin (Adcetris) plus AVD in Patients (age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

Eligibility: All patients must have histologically confirmed newly diagnosed, previously untreated Stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)). Nodular lymphocyte predominant Hodgkin Lymphoma is not eligible. Patients must have bidimensionally measurable disease (at least one lesion with longest diameter greater than or equal to 1.5 cm). Patients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. Pts. must be greater than or equal to 12 years of age.

Objectives: Primary: To compare the PFS in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD versus that obtained with BV-AVD. Secondary:To compare OS, EFS, CR in pts rand. to N-AVD vs. BV-AVD and the safety and tolerability of N-AVD vs BV-AVD. To compare physician-reported treatment related AE rates b/w arms stratified by age. To compare pt reported symptoms using selected PRO-CTCAE items between arms stratified by age.

NCT Registration ID (from clinicaltrials.gov): NCT03907488
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Open
Activation Date: December 08, 2020

Chairs: (Canada) Dr. Kelly Davison, The Research Institute of the McGill University, 1
(Canada) Dr. Angela Punnett, The Hospital for Sick Children, 1(416) 813-5872
(Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567

LY9

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)

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(MINT)
Status: Closed
Activation Date: May 08, 2001 , Closing Date: October 17, 2003

Chairs: (Canada) Dr. Kevin R. Imrie, Odette Cancer Centre, 1(416) 480-5000 Ext. 5145

LY10

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
Status: Closed
Activation Date: December 12, 2000 , Closing Date: July 12, 2002

Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567
(Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567

LY12

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.

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: Intergroup(CCTG)
Status: Closed
Activation Date: August 07, 2003 , Closing Date: December 31, 2012

Chairs: (Italy) Prof. Massimo Federico, Gruppo Italiano Studio Linfomi (GISL), 01139(59) 422-4383
(Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567

LY13

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
Status: Closed
Activation Date: December 14, 2006 , Closing Date: March 06, 2009

Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567
(Canada) Dr. Laurie Sehn, BCCA - Vancouver Clinic, 1(604) 877-6000 Ext. 2736

LY16

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

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(LYSARC)
Status: Closed
Activation Date: June 17, 2013 , Closing Date: November 10, 2014

Chairs: (Canada) Dr. Laurie Sehn, BCCA - Vancouver Clinic, 1(604) 877-6000 Ext. 2736

LY17

A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

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: Intergroup(CCTG)
Status: On Hold
Activation Date: May 05, 2015

Chairs: (Canada) Dr. John Kuruvilla, University Health Network, 1(416) 946-2827
(Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567

LY18

A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma

Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at most recent relapse, with clinically and/or radiologically measureable disease. Patients with de novo aggressive B-cell lymphoma must have relapsed or progressed, or have biopsy proven refractory disease, after one prior line of therapy (R-CHOP chemotherapy or equivalent). Patients with histological transformation from low-grade lymphoma may have had up to 3 prior treatment regimens. Patients with transformed low grade lymphoma treated with a non-anthracycline regimen may be enrolled at investigator discretion Patients must be 16 years old or older, must be an appropriate candidate to receive second-line salvage chemotherapy, and must be considered fit for intensive chemotherapy and ASCT.

Objectives: The primary objective is to establish the recommended phase II dose of new combination therapy in individuals with relapsed and refractory lymphoma. Secondary objectives include determining the overall response rate using RECIL and Lugano response criteria, evaluating the tolerability and toxicity, determining the stem cell collection rate and transplantation rate, and determine overall survival and event free survival. An exploratory objective is to assess molecular factors, which may be prognostic or predictive of response.

NCT Registration ID (from clinicaltrials.gov): NCT04161248
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(CCTG)
Status: Open
Activation Date: December 06, 2019

Chairs: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, 1(514) 340-8207

LYC1

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)

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(ECOG)
Status: Closed
Activation Date: March 12, 2014 , Closing Date: September 09, 2016

Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567

MDC1

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)

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(SWOG)
Status: Closed
Activation Date: November 22, 2012 , Closing Date: November 15, 2014

Chairs: (Canada) Dr. Rena Buckstein, Odette Cancer Centre, 1(416) 480-5000 Ext. 5847

MY11

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
Status: Closed
Activation Date: December 13, 2005 , Closing Date: March 27, 2008

Chairs: (Canada) Dr. Darrell White, QEII Health Sciences Centre, 1(902) 473-4642

MYC2

Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

Eligibility: STEP 1 (REG) - (1) Confirmed diagnosis of symptomatic multiple myeloma that required systemic induction therapy prior to stem cell transplant (ASCT). (2) No organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction. (3) No prior progressive disease. (4) Refractory to or intolerant to either lenalidomide or daratumumab/rHuPH20 (5) Must have initiated induction therapy within 12mo prior to reg Step 1 (at least 2 cycles therapy). (6) over 18 under 75 years of age, physical exam, Zubrod 2 or less, adequate renal and liver function (7) mandatory had/will have standard stem cell transplant (8) - STEP 2 (Rand 1) - (1) ASCT within 180 days and no maintenance therapy and no progressive disease (2) scan for disease assessment (3) adequate hepatic and renal function - STEP 3 (Rand 2) (1) completed 24 cycles of maintenance lenalidomide or lenalidomide+dara (2) be 24mo MRD neg in very good partial remission.

Objectives: Primary objective: To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients. Secondary objectives: Overall Response Rate (ORR), Progression-Free Survival (PFS), Evaluate MRD-negativity between arms, compare toxicity and tolerability of long term therapy between arms. Compare OS between MRD negative patients between groups. Additional objectives: To report the findings of the 24-month MRD analysis as early as 24 months after all patients have been accrued.

NCT Registration ID (from clinicaltrials.gov): NCT04071457
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Planned


Chairs: (Canada) Dr. Christopher Venner, Cross Cancer Institute, 1(780) 432-8757

LUNG STUDIES

BR31

A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer

Eligibility: Completely resected primary stage IB (>= 4cm), II and IIIA non-small cell lung cancer patients (with or without adjuvant platinum based chemotherapy).

Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Disease free survival (DFS) in all randomized patients. Secondary Objectives: Overall survival (OS) for patients with NSCLC that is PD-L1 positive, OS for all randomized patients, lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients, adverse effects and tolerability of MEDI4736, Quality of Life, survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, economic evaluation (cost effectiveness and cost utility), evaluation of predictive/prognostic significance of PD-L1 expression, evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event, exploratory pharmacogenomic assays (baseline only).

NCT Registration ID (from clinicaltrials.gov): NCT02273375
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(CCTG)
Status: Closed
Activation Date: October 09, 2014 , Closing Date: March 27, 2020

Chairs: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, 1(613) 737-8899 Ext. 73955
() Dr. Yi-Long Wu, Chinese Thoracic Oncology Group,
(Italy) Dr. Francesco Perrone, Istituto Nazionale Tumori, 01139(81) 590-3571

BR34

A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Eligibility: - histologically and/or cytologically confirmed squamous or non-squamous NSCLC confirmed by IHC. Known EGFR mutations or ALK fusions are NOT eligible. - stage IVA or IVB per TNM version 8 staging criteria - 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: Intergroup(CCTG)
Status: Closed
Activation Date: February 15, 2017 , Closing Date: November 07, 2018

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BR36

A Biomarker-Directed, Open Label, Multi-Centre Phase II Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients with Non-Small Cell Lung Cancer

Eligibility: MAIN INCLUSION CRITERIA: Histologically or cytologically confirmed stage IV EGFR and ALK negative NSCLC or T4NX (Stage IIIB) with nodule in ipsilateral lobe if patient not a candidate for chemotherapy + radiation. PD-L1 expression TPS 50% or more. Eligible to receive treatment with pembrolizumab. ECOG 0 or 1. Measurable disease per RECIST 1.1. Available tissue block from primary or metastatic tumor. Mandatory blood collection for ctDNA analysis. MAIN EXCLUSION CRITERIA: Active or prior autoimmune disorders. Active brain or leptomeningeal metastases. Untreated or uncontrolled cardiovascular conditions.

Objectives: Primary: Identify optimal time points for molecular response as assessed by ctDNA assay and validate concordance of molecular response with radiologic response. Secondary: evaluate time to molecular response, correlate molecular response to RECIST response, PFS and OS,to explore degree of ctDNA reduction with clinical outcomes. Tertiary: collect archival tumour tissue for translational research studies.

NCT Registration ID (from clinicaltrials.gov): NCT04093167
Participation: Limited to invited centres; Site Selection Closed
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Open
Activation Date: October 17, 2019

Chairs: (USA) Valsamo Anagnostou, The Sidney Kimmel Comprehensive Cancer Centre, (410) 502-3696
(Canada) Dr. Cheryl Ho, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2445

BRC2

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)

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(ECOG)
Status: Closed
Activation Date: August 28, 2007 , Closing Date: September 20, 2013

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645
(Canada) Dr. Charles Butts, Cross Cancer Institute, 1(780) 432-8513

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)

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).

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(NCIC CTG)
Status: Closed
Activation Date: August 28, 2007 , Closing Date: September 20, 2013

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BRC5

A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (

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 resec tion.

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

Chairs: (Canada) Dr. Massimo Conti, University Institute of Cardiology and, 1(418) 656-8711

BRC6

A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer

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(SWOG)
Status: Closed
Activation Date: April 15, 2016 , Closing Date: July 12, 2018

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BRC6B

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)

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
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: April 15, 2016 , Closing Date: December 13, 2016

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BRC6C

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)

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
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: April 15, 2016 , Closing Date: September 01, 2016

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BRC6D

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

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
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: April 15, 2016 , Closing Date: October 31, 2016

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BRC6G

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)

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.

Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: September 20, 2017 , Closing Date: July 12, 2018

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BRC6I

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)

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
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: April 15, 2016 , Closing Date: April 23, 2018

Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645

BRC7

INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis

Eligibility: Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC (includes M1a, M1b, and M1c stage disease. Patients with T4NX disease (Stage IIIB) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation. Patients must have PD-L1 expression Tumor Proportion Score (TPS)greater than or equal to 1% in tumor cells. Patients must have measurable or non-measureable disease.

Objectives: Co-primary objective is to evaluate overall survival (OS) in each of the 2 experimental arms (Arms A and B) to control (Arm C). To evaluate progression-free survival (PFS) for Arm C versus each of Arms A and B; best objective response rates for Arm C versus each of Arms A and B; to estimate toxicity within each of the treatment arms via the CTCAE criteria, compare outcomes b/w Arms A & B, and outcomes by treatment arm within subgroups defined by a cutpoint of PD-L1 expression at > 50%.

NCT Registration ID (from clinicaltrials.gov): NCT03793179
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(ECOG-ACRIN)
Status: Open
Activation Date: July 10, 2019

Chairs: (Canada) Dr. Andrew Robinson, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 8104

BRC8

MRI Brain Surveillance Alone versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Eligibility: Disease Related Criteria: a) Patient must have a histologically confirmed diagnosis of small-cell lung cancer(SCLC). b) Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease. Prior/Concurrent Therapy Criteria: a) Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating pysician. b) All adverse events from prior treatment must have resolved to Grade 2 (CTCAE Version 5.0) prior to randomization. c) Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. d) No more then 8 weeks elapsed between D1 of last cycle of chemotherapy and radomization e) Patient must not have received prior radiotherapy to the brain or WBRT.

Objectives: Primary Objective: To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). Secondary Objectives: To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms. To compare brain-metastasis-free survival between the arms. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms. To compare the frequency and severity of toxicities between the two arms. Additional Objectives: To collect blood for banking.

NCT Registration ID (from clinicaltrials.gov): NCT04155034
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Open
Activation Date: May 27, 2020

Chairs: (Canada) Dr. Jonathan Greenland, Dr. H. Bliss Murphy Cancer Centre, 1(709) 777-7802

MELANOMA STUDIES

ME10

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

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(ECOG)
Status: Closed
Activation Date: September 14, 1999 , Closing Date: October 26, 2010

Chairs: (Canada) Dr. Michael Smylie, Cross Cancer Institute, 1(780) 432-8757

ME13

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

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: Intergroup(CCTG)
Status: Open
Activation Date: July 04, 2016

Chairs: (Canada) Dr. Tara Baetz, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 6654
(Canada) Dr. Xinni Song, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 70208

ME15

Melanoma Margins Trial: A Phase III, Multi-centre, Multi-national Randomized Control Trial Investigating 1cm vs 2cm Wide Excision Margins for Primary Cutaneous Melanoma (MelMarT-II)

Eligibility: Patients are eligible if all the following requirements are met: 18 years or older, Histologically confirmed, primary invasive cutaneous melanoma: AJCC 8th edition Stage IIA-IIC (pT2b-pT4b), ECOG performance status 0-1 at randomisation, able to give informed consent, and comply with protocol treatment and follow up, randomisation and treatment must be performed within 120 days of diagnosis, patients must have no previous malignancy or primary except low-risk non-melanoma skin cancer (unless in remission and >5 years since diagnosis).

Objectives: This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition).The study is designed to be able to prove or disprove that there is no difference in risk of melanoma recurrence between the two groups of patients. This study is designed to show that the risk of long-term pain associated with surgery can be reduced. If the study achieves its primary objective and demonstrates safety with a narrower margin, then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.

NCT Registration ID (from clinicaltrials.gov): NCT03860883
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(MASC)
Status: Open
Activation Date: July 30, 2020

Chairs: (Canada) Dr. Frances C. Wright, Odette Cancer Centre, 1(416) 480-5000 Ext. 3835

MEC3

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma

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(ECOG)
Status: Closed
Activation Date: October 02, 2012 , Closing Date: August 15, 2014

Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-4270

MEC5

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

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(SWOG)
Status: Closed
Activation Date: January 15, 2016 , Closing Date: November 02, 2017

Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-4270

OTHERS STUDIES

PM1

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

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: Intergroup(CCTG)
Status: Open
Activation Date: October 06, 2017

Chairs: (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672357
(Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911

PM1S

Insight of the Use and Value of Genomic Analysis in Cancer Patients: A Pan-Canadian Survey of Oncologists and Patients

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 will haveundergone standard testing as indicated by local/provincial practice for diagnosis Medical oncologists must be QIs or SIs active on the PM.1 Participants List and must be from a site which is participating on the PM.1/CAPTUR trial..

Objectives: Primary Objective 1. To determine how Canadian oncologists, from academic cancer centres, use Next-Generation Sequencing (NGS) tests to evaluate patients with metastatic disease who have already undergone standard of care diagnostic testing and inform treatment recommendations, pre- and post-testing. Secondary Objectives 1. To determine patient's satisfaction with their decision-making using a validated tool, pre- and post-NGS testing 2. To obtain feedback from oncologists on the decision impact of NGS and requirements to increase the usage of precision medicine

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Open
Activation Date: June 08, 2020

Chairs: (Canada) Dr. Philippe Bedard, University Health Network, 1(416) 946-4501 Ext. 4534

SARCOMA STUDIES

SR3

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

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(EORTC)
Status: Closed
Activation Date: October 05, 1999 , Closing Date: December 15, 2003

Chairs: (Canada) Dr. Vivien H. Bramwell, Tom Baker Cancer Centre, 1(403) 521-3707

SR5

Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma

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(EORTC)
Status: Closed
Activation Date: July 03, 2007 , Closing Date: May 11, 2010

Chairs: (Canada) Dr. Stewart Rorke, Dr. H. Bliss Murphy Cancer Centre, 1(709) 777-7802

SR7

A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

Eligibility: Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis, unifocal resectable tumour, radiologically measurable disease (RECIST 1.1), 18 years old or older, WHO ps 0-2, adequate haematological and organ function, ASA < 3, negative serum pregnany test, consent to use higly effective birth control measures throughout duration of study and for at least 6 months after last treatment. No sarcoma originating from bone structure, abdominal or gynecological viscera, no metastatic disease, no previous treatment to present tumour, no hypersensitivity to doxorubicin, ifosfamide, dacarbazine or any of their metabolites/excipients, no recent or uncontrolled cardiac disease, no active or uncontrolled infections, and/or no live vaccines within 30 days of study entry.

Objectives: The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of patients with high risk de-differentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) as measured by disease-free survival.

NCT Registration ID (from clinicaltrials.gov): NCT04031677
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(EORTC)
Status: Open
Activation Date: February 01, 2021

Chairs: (Canada) Dr. Rebecca Gladdy, Sinai Health System, 1

SRC5

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(SWOG)
Status: Closed
Activation Date: April 15, 2009 , Closing Date: September 17, 2009

Chairs: (Canada) Dr. Karen Mulder, Cross Cancer Institute, 1(780) 432-8514

SRC6

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

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(COG)
Status: Closed
Activation Date: December 05, 2014 , Closing Date: October 22, 2018

Chairs: (Canada) Dr. Mohamed A.M. Akra, CancerCare Manitoba, 1(204) 787-1210

SYMPTOM CONTROL STUDIES

IC8

COV-IMMUNO - A Randomized, Phase III Trial of Immunization with IMM-101 versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

Eligibility: Patients must be: -undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma, requiring them to present to the hospital or cancer clinic at least twice/month for assessments and/or treatments, anticipated for at least 3 months. - have one or more of the following risk factors for a severe COVID-19 infection: Age > 65 years old; Hypertension (on medications); Type 1 or 2 Diabetes (on medication); A relevant chronic condition as per the investigator based on the medical record including heart, lung, liver and/or serious kidney disease; receiving systemic therapy; Body Mass Index > 40; Living in a nursing home or long term care facility. - Age 18 or greater and an ECOG PS of 0-2

Objectives: Primary objective: to investigate the effectiveness of IMM 101 at preventing "influenza-like illnesses" (ILI), as defined by the WHO, OR a confirmed viral/bacterial respiratory infection (via microbiology or radiography), AND that results in a change or delay in a priori planned cancer treatment or requirement for an unscheduled medical assessment (i.e. emergency room visit, family physician assessment, etc.), hospitalization, or death compared to control subjects. Numerous Secondary and Tertiary/Exploratory Objectives planned.

NCT Registration ID (from clinicaltrials.gov): NCT04442048
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Open
Activation Date: June 25, 2020

Chairs: (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 72791

ICC1

NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Eligibility: Patients must have a prior or current cancer diagnosis, that fits into one of the following categories: - Patient is receiving active treatment (current or within the last 6 weeks) for metastatic cancer - Patient is receiving adjuvant treatment + had IV chemotherapy, immuno or targeted therapy, endocrine therapy, or RT in the last 6 weeks - Patient received ASCT, CAR-T or modified cell therapy at any time - Patient is receiving treatment or prophylaxis or host disease, or received bone marrow transplant within the past 2 years. Patients must have had a positive COVID-19 test within the last 14 days using any specimen source. Patients with brain mets or HIV are eligible. Co-enrollment on other clinical trials is allowed.

Objectives: 1. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. 2. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. 3. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics. 4. Correlative study objectives by collection, storage, and research of blood specimens and radiological images.

NCT Registration ID (from clinicaltrials.gov): NCT04387656
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(NCRI)
Status: Open
Activation Date: June 18, 2020

Chairs: (Canada) Dr. Nathalie Daaboul, Hopital Charles LeMoyne, 1(450) 466-5000

SC19

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
Status: Closed
Activation Date: February 28, 2001 , Closing Date: January 31, 2004

Chairs: (Canada) Dr. Rebecca Wong, University Health Network, 1(416) 946-2126

SC20

A Phase III International Randomized Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases

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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: January 07, 2004 , Closing Date: May 24, 2012

Chairs: (France) Dr. Jean-Leon Lagrange, Assistance Publique Hopitaux de Paris (APHP), 01133(14) 981-4524
(The Netherlands) Dr. Yvette van der Linden, Radiotherapeutic Institution Friesland, 01131(58) 286-6667
(Australia) Dr. Daniel Roos, Royal Adelaide Hospital, 01161(8) 8222-4000
(UK) Dr. Peter Hoskin, Univ. College of London Clinical Trials Unit, 01144(1923) 844533
(Canada) Dr. Edward L.W. Chow, Odette Cancer Centre, 1(416) 480-4998
(Canada) Dr. Jackson Wu, Tom Baker Cancer Centre, 1(403) 521-3095
(USA) Dr. William Hartsell, Advocate Good Samaritan Cancer Center, 1(630) 275-2300

SC20U

A phase III study of the effect of re-irradiation for bone pain on urinary markers of osteoclast activity.

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.

NCT Registration ID (from clinicaltrials.gov): no NCT
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: Intergroup(NCIC CTG)
Status: Closed
Activation Date: July 06, 2004 , Closing Date: May 24, 2012

Chairs: (UK) Dr. Peter Hoskin, Univ. College of London Clinical Trials Unit, 01144(1923) 844533
(Canada) Dr. Edward L.W. Chow, Odette Cancer Centre, 1(416) 480-4998

SC23

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

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
Status: Closed
Activation Date: November 22, 2010 , Closing Date: December 12, 2014

Chairs: (Canada) Mr. Carlo DeAngelis, Odette Cancer Centre, 1(416) 480-6100 Ext. 1085
(Canada) Dr. Alysa Fairchild, Cross Cancer Institute, 1(780) 432-8516
(Canada) Dr. Edward L.W. Chow, Odette Cancer Centre, 1(416) 480-4998

SC24

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

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) Spinal Instability Neoplastic Score at 3 and 6 months; (4) Overall Surivval; (5) Adverse event profile; (6) Healthe-related Quality of Life; (7) Economic Analysis; (8) Radiotherapy Quality Assurance (RTQA) compliance. TERTIARY ENDPOINTS: (1) Radiomics; (2) Biobanking for future correlative studies 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: Intergroup(CCTG)
Status: Closed
Activation Date: July 28, 2015 , Closing Date: September 27, 2019

Chairs: (Canada) Dr. Arjun Sahgal, Odette Cancer Centre, (416) 480-4834

SC26

Emotion and Symptom-focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals with Acute Leukemia

Eligibility: Patients with newly-diagnosed acute leukemia (AL) within 2 weeks of admission who will be receiving induction chemotherapy with curative intent. Patients must be fluent in English and must pass the cognitive screening test.

Objectives: PRIMARY OBJECTIVE: To determine the effectiveness of EASE vs. usual care (UC) to reduce psychological distress and physical symptom severity in adults with newly diagnosed acute leukemia after 8 weeks of implementation. SECONDARY OBJECTIVE: (1) To determine the effectiveness of EASE vs. UC to reduce psychological distress and physical symptom severity after 4 and 12 weeks, 6 months, and 1 year; (2) to determine the effects of EASE vs UC on other domains of health-related quality of life; and (3) to conduct post-trial, an economic analysis of EASE to determine the cost-effectiveness of EASE delivery in relation to its effect on reduction of distress in individuals with AL compared to UC.

NCT Registration ID (from clinicaltrials.gov): NCT04224974
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Open
Activation Date: December 23, 2019

Chairs: (Canada) Dr. Gary Rodin, University Health Network, (416) 946-4504
(Canada) Dr. Camilla Zimmermann, University Health Network, 1(416) 946-2135

SC27

Living with Cancer in the Time of COVID-19: A Cohort Study of the Impact of the COVID-19 Pandemic on Cancer Patients During Treatment and Survivors

Eligibility: >=18 years of age: any cancer diagnosis in the last 10 years, any stage; must be able to read/ write english or french

Objectives: Primary objectives 1. Describe the pattern of psychosocial and physical symptom severity, and QOL over time and differences by sub-groups (e.g., age, gender, cancer stage) 2. Assess participants' perceptions of their experience and satisfaction of cancer care over time 3. Identify the coping strategies, and health and safety actions used by patients and survivors during cancer diagnosis, treatment, and recovery in the context of COVID-19 Secondary objectives 4. Examine factors associated with psychosocial and physical symptom severity, poor QOL and other clinical outcomes (e.g., COVID-19 status, hospitalization, and mortality). 4a. Explore effect modification by selected subgroups (e.g., age, sex, gender, cancer stage)

NCT Registration ID (from clinicaltrials.gov): no NCT
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Open
Activation Date: June 30, 2020

Chairs: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, 1(403) 355-3207

SC28

The SEEMLESS Study: A randomized trial of a SmartphonE App-based MindfuLnEss intervention for cancer SurvivorS

Eligibility:

Objectives:

Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Planned


Chairs: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, 1(403) 355-3207

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