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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: April 18, 2014

Disease Sites

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

BRAIN

CE2
CE3
CE4
CE5
CE5S
CE6
CEC1
CEC2
CEC3

BREAST

MA17
MA17B
MA17L
MA17R
MA20
MA21
MA22
MA23
MA24
MA25
MA26
MA27
MA27B
MA27D
MA28
MA29
MA31
MA32
MA32D
MA32F
MA33
MA34
MA35
MA36
MAC1
MAC2
MAC3
MAC4
MAC4C
MAC5
MAC6
MAC7
MAC8
MAC9
MAC11
MAC12
MAC13
MAC14
MAC15
MAC16
MAC17
MAP1
MAP2
MAP3
MAP3B

GASTRO-INTESTINAL

BI1
CO13
CO14
CO16
CO17
CO20
CO21
CO22
CO23
CO24
CRC1
CRC2
CRC3
CRC4
CRC5
CRC6
CRC7
ES2
GA1
GA2
GAC1
HEC1
NEC2
NEC3
PA2
PA3
PA6
PAC1
PAC2
HE1

GENITO-URINARY

BL7
BL8
BL10
BL11
BL12
BLC1
PR3
PR7
PR8
PR9
PR10
PR10C
PR11
PR12
PR13
PR15
PR17
PRC2
PRC3
PRC4
PRP1
PRP1B
REC1
REC2

GYNECOLOGIC

CX4
CX5
CXC1
EN5
EN7
GT1
OV13
OV15
OV16
OV17
OV18
OV19
OV21
OV23

HEAD AND NECK

HN3
HN4
HN5
HN6

HEMATOLOGIC

AL3
AL4
AL5
ALC1
ALC2
ALC3
CL2
CL3
CLC1
CLC2
CM1
HD6
HD7
HD8
LY7
LY9
LY10
LY11
LY12
LY13
LY15
LY16
LYC1
MY7
MY10
MY11
MDC1

LUNG

BR15
BR15C
BR16
BR17
BR18
BR19
BR20
BR21
BR22
BR22C
BR23
BR23C
BR24
BR25
BR26
BR28
BR29
BRC1
BRC2
BRC2E
BRC3
BRC4
BRC5

MELANOMA

ME10
ME11
ME12
MEC3

SARCOMA

SR3
SR5
SRC1
SRC5
SR6

SYMPTOM CONTROL

SC18
SC19
SC20
SC20U
SC22
SC23
SC24

BRAIN STUDIES

CE2

Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas.

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

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

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

Chairs: (Canada) Dr. Normand J. Laperriere, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2127
(Canada) Dr. Meg Knowling, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2445

CE3

A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme

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

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

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

Chairs: (Switzerland) Dr. Roger Stupp, University Hospital CHUV, 01141(21) 314-0156
(Canada) Dr. Barbara J. Fisher, London Regional Cancer Program, 1(519) 685-8650

CE4

Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study.

Eligibility:

Objectives:

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

Chairs: (Canada) Dr. Luis Souhami, Montreal General Hospital, 1(514) 934-8040 Ext. 43163
(Canada) Dr. Rolando Del Maestro, Montreal Neurological Institute & Hospital, 1(514) 398-5791

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: April 11, 2013

Chairs: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2277
(Canada) Dr. Dorianne Rheaume, QEII Health Sciences Centre, 1(902) 473-6096

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.

Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Closed
Activation Date: June 11, 2007 , Closing Date: April 11, 2013

Chairs: (Canada) Ms. Maureen Parkinson, BCCA - Vancouver Cancer Centre, 1

CE6

A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients.

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

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

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

Chairs: (Canada) Dr. Normand J. Laperriere, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2127
(Canada) Dr. James Perry, Odette Cancer Centre, 1(416) 480-5000 Ext. 4766
(Australia) Dr. Claire Phillips, Trans-Tasman Radiation Oncology Group, 01161

CEC1

Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial. (RTOG 0834)

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: Open
Activation Date: July 22, 2009

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. egistration . 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: On Hold
Activation Date: July 28, 2010

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

CEC3

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

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

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

NCT Registration ID (from clinicaltrials.gov): NCT01372774
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(NCCTG)
Status: Open
Activation Date: September 29, 2011

Chairs: (Canada) Dr. David Roberge, CHUM - Hopital Notre-Dame, 1(514) 890-8254
(Canada) Dr. David Roberge, CHUM - Hopital Notre-Dame, 1(514) 890-8254

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: (Belgium) Dr. Martine Piccart, Institut Jules Bordet, 01132(2) 541-3111
(USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118
(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
(Switzerland) Dr. Monica Castiglione-Gertsch, SIAK/IBCSG Operations Office, 01141(31) 389-9191
(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 12, 2009

Chairs: (Belgium) Dr. Martine Piccart, Institut Jules Bordet, 01132(2) 541-3111
(USA) Dr. Nicholas J. Robert, , 1(703) 280-5390
(USA) Dr. Hyman B. Muss, Physicians Office Building, 1(919) 966-4431
(USA) Dr. Silvana Martino, John Wayne Cancer Institute, 1(310) 998-3961
(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

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

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: (Canada) Dr. Mark Levine, Henderson Hospital, 1(905) 527-4322 Ext. 42176
(USA) Dr. Edith Perez, Mayo Clinic Jacksonville, 1(904) 953-7283
(USA) Dr. Kathy S. Albain, Loyola University Medical Center, 1(708) 327-3102
(Canada) Dr. Margot Burnell, Atlantic Health Sciences Corporation, 1(506) 648-6884
(USA) Dr. Hope Rugo, University of California, 1(415) 353-7618

MA22

A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer

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

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

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

Chairs: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, 1(416) 480-5145
(Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, 1(416) 480-5145

MA23

Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients

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

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

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

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

MA24

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

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

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

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

Chairs: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032
(Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, 1(416) 480-4616

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

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. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495
(Canada) Dr. Eileen Rakovitch, Odette Cancer Centre, 1(416) 480-4806

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. 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
(USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, 1(507) 284-1887
(USA) Dr. Paul Goss, Massachusetts General Hospital Cancer Center, 1(617) 724-3118

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. Philip J. Stella, NCCTG, Mayo Clinic, 1(507) 284-1159
(USA) Dr. James N. Ingle, NCCTG, Mayo Clinic, 1(507) 284-1887
(Canada) Dr. Kathleen I. Pritchard, Odette Cancer Centre, 1(416) 480-4616
(USA) Dr. Wilma Lingle, NCCTG, Mayo Clinic, (507) 266-0954
(USA) Ms. Celine M. Vachon, NCCTG, Mayo Clinic, 1(507) 284-1159

MA28

Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment For Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer

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

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

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

Chairs: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032

MA29

A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.

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

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

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

Chairs: (Canada) Dr. Maureen E. Trudeau, Odette Cancer Centre, 1(416) 480-5145

MA31

A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer

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

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

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

Chairs: (Canada) Dr. Karen Gelmon, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032

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(NCIC CTG)
Status: Closed
Activation Date: June 25, 2010 , Closing Date: January 22, 2013

Chairs: (Canada) Dr. Pamela J. Goodwin, Univ. Health Network-Princess Margaret Hospital, 1(416) 586-8605
(UK) Prof. Judith Bliss, Institute of Cancer Research, 01144(208) 722-4297
(Switzerland) Dr. Manuela Rabaglio, IBCSG Coordinating Centre, 01141(44) 387-2550
(UK) Dr. Alastair Thompson, Institute of Cancer Research, 01144(0208) 722-4013

MA32D

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

Eligibility:

Objectives:

NCT Registration ID (from clinicaltrials.gov): NCT01666171
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ALLIANCE)
Status: Planned


Chairs: (Canada) Dr. Pamela J. Goodwin, Univ. Health Network-Princess Margaret Hospital, 1(416) 586-8605
(Canada) Dr. Pamela J. Goodwin, Univ. Health Network-Princess Margaret 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.

Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(NSABP)
Status: Closed
Activation Date: October 28, 2011 , Closing Date: January 25, 2013

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

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: Open
Activation Date: April 29, 2009

Chairs: (Canada) Dr. Ivo A. Olivotto, Tom Baker Cancer Centre, 1(403) 521-3105

MA34

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer

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

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

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

Chairs: (Canada) Dr. Susan Dent, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70167

MA35

Regional Irradiation in Limited Nodal Disease

Eligibility: T1, T2 invasive breast cancer treated by BCS+SLNB alone with 1-2 positive SLN (including micrometastases and ITCs) High-risk LN-ve (T > 2 cm and 1 additional RF: age < 40 years, Gr 3, ER-ve, LVI+, >30 RS) Age > 18 years Informed written consent to participate ECOG PS 0-2 Life expectancy > 5 years

Objectives: Primary: Disease Free Survival Secondary: Overall survival; Locoregional recurrence; Distant recurrence; Toxicity (lymphedema, pneumonitis, cardiac toxicity, brachial plexopathy); Cosmesis; Quality of life

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


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

MAC1

A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer

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

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

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

Chairs: (Canada) Dr. Debjani Grenier, CancerCare Manitoba, St. Boniface General Hospital, 1(204) 235-3728

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

MAC4

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

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

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

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

Chairs: (Canada) Dr. Barbara A. Walley, Tom Baker Cancer Centre, 1(403) 521-3688

MAC5

A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer

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

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

Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(IBCSG)
Status: Closed
Activation Date: October 07, 2003 , Closing Date: March 11, 2011

Chairs: (Canada) Dr. Barbara A. Walley, Tom Baker Cancer Centre, 1(403) 521-3688

MAC6

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

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

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

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

Chairs: (Canada) Dr. Barbara A. Walley, Tom Baker Cancer Centre, 1(403) 521-3688

MAC7

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

Eligibility: Post menopausal women with metastatic breast cancer

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

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

Chairs: (Canada) Dr. Ted A. Vandenberg, London Regional Cancer Program, 1(519) 685-8640

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 Health Research Institute - General Division, 1(613) 737-7700 Ext. 70166

MAC9

Randomized 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 Health Research Institute - General Division, 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 16, 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:

Objectives:

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

MAC14

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

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

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

NCT Registration ID (from clinicaltrials.gov): NCT01242800
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ECOG)
Status: Open
Activation Date: June 22, 2011

Chairs: (Canada) Dr. Mark Basik, McGill University, Dept. Oncology, 1(514) 340-8222 Ext. 8248

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:

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: Open
Activation Date: October 05, 2011

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

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
(Canada) Dr. David Warr, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 2260

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

BI1

Phase III Trial of Combined Gemcitabine Plus Capecitabine Chemotherapy Versus Gemcitabine Alone in Advanced Biliary Cancer.

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

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

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

Chairs: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2399

CO13

A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-fluorouracil (5-FU), and Irinotecan (CPT-11) as Initial Treatment of Patients with Advanced Adenocarcinoma of the Colon and Rectum

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

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

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

Chairs: (Canada) Dr. Brian Findlay, Niagara Health System, 1(905) 684-7271 Ext. 43801

CO14

Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon

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

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

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

Chairs: (Canada) Dr. Anthony Fields, Alberta Cancer Board, 1(780) 643-4482

CO16

A Randomized Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer.

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

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

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

Chairs: (Canada) Dr. Jean Couture, L'Hotel-Dieu de Levis, 1(418) 835-7121 Ext. 3048

CO17

A Phase III Randomized Study of Cetuximab (Erbitux TM, C225) and Best Supportive Care versus Best Supportive Care in Patients with Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR) - Positive Colorectal Carcinoma

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

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

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

Chairs: (Canada) Dr. Derek Jonker, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70168

CO20

A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination with Cetuximab (Erbitux) Versus Placebo in Combination with Cetuximab (Erbitux) in Patients With K-Ras Wild Type Tumours Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma

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

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

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

Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911
(Australia) Dr. Jeremy Shapiro, Alfred Hospital, 01161(3) 9276-3129

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

CO22

Phase II Study Of Radiation Versus Radiation Plus Chemotherapy With Palliative Intent In Locally Advanced Or Locally Recurrent Rectal Cancer

Eligibility: Inclusion Criteria . Biopsy proven primary rectal adenocarcinoma . Treatment with palliative intent . locally advanced unresectable, locoregionally recurrent or locoregional disease with metastases . Significant clinical symptoms related to the pelvic rectal cancer for which radiation is indicated . Expected survival . 6 months . ECOG 0 - 2 Exclusion Criteria: . Prior pelvic radiotherapy . Fistula . Rectal stents in situ, or clinical or radiographic evidence of pending bowel obstruction . Significant metastatic disease burden where it is expected that systemic chemotherapy would be required within 8 weeks of randomization . Prior chemotherapy is not an exclusion criterion provided it was given >=4 weeks prior to enrolment

Objectives: Primary: QoL Secondary: Overall Survival; Economic; QoL

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


Chairs: (Canada) Dr. James Biagi, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 4503
(Canada) Dr. Conrad Falkson, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 544-2631 Ext. 4509

CO23

A Randomized Phase III Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma

Eligibility: Patients with pre-treated advanced colorectal carcinoma.

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

NCT Registration ID (from clinicaltrials.gov): NCT01830621
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Open
Activation Date: April 15, 2013

Chairs: (Canada) Dr. Derek Jonker, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70168

CO24

Preoperative High Dose Rate Endorectal Brachtherapy as an Alternate Down Staging Modality for Patients with Resectable Rectal Cancer

Eligibility:

Objectives:

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


Chairs: (Canada) Dr. Te Vuong, Jewish General Hospital, 1(514) 340-8222

CRC2

A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

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

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

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

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

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. (Criteria not

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

CRC4

Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation

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

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

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

Chairs: (Canada) Dr. James D. Brierley, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2124

CRC5

A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

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

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

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

Chairs: (Canada) Dr. Scott Berry, Odette Cancer Centre, 1(416) 480-4270

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(CALGB)
Status: Open
Activation Date: March 28, 2011

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

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: Open
Activation Date: October 17, 2012

Chairs: (Canada) Dr. Hagen Kennecke, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032
(Canada) Dr. Erin Kennedy, Mount Sinai Hospital, 1(416) 586-4800 Ext. 6872

ES2

A Randomized Phase III Study in Advanced Oesophageal Cancer To Compare Quality of Life and Palliation of Dysphagia In Patients Treated With Radiotherapy Versus Chemo-Radiotherapy.

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

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

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

Chairs: (Canada) Dr. Rebecca Wong, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2126

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): ACTRN12609000035224
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, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2126

GA2

INTEGRATE-A Randomized Phase II Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Esophago-Gastric Cancer (AEGC)

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

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

NCT Registration ID (from clinicaltrials.gov): ACTRN12612000239864
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(AGITG)
Status: Closed
Activation Date: December 14, 2012 , Closing Date: March 13, 2013

Chairs: (Canada) Dr. Thierry Alcindor, McGill University - Dept. Oncology, 1(514) 934-1934 Ext. 43118

GAC1

Phase III Randomized Study of Adjuvant Chemoradiation After Resection in Patients with Gastric or Gastroesophageal Adenocarcinoma

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

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

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

Chairs: (Canada) Dr. Georg A. Bjarnason, Odette Cancer Centre, 1(416) 480-6100 Ext. 5847

HEC1

Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)

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

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

NCT Registration ID (from clinicaltrials.gov): NCT01015833
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(CALGB)
Status: Open
Activation Date: January 03, 2011

Chairs: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2399

NEC2

Randomized Phase II Study of Everolimus Alone versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours

Eligibility: Histologically documented well or moderately differentiated neuroendocrine tumor;Locally advanced or metastatic Clinical or histologic evidence of a pancreatic primary site; No prior therapy with temozolomide, VEGF or VEGFR inhibitors, everolimus or other mTOR inhibitors Patients must have measurable or non-measurable disease; Other prior treatments, including cytotoxic chemotherapy, alpha interferon, and radiopeptide therapy, are allowed; Prior embolization or ablative therapies are allowed if measurable disease remains; Somatostatin analog treatment is allowed, but not a requirement; Major surgery and cytotoxic regimens should be completed 4 weeks before start of treatment; Minor surgery should be completed 2 weeks before start of treatment. ECOG 0-2

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

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

Chairs: (Canada) Dr. Hagen Kennecke, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2032

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: Open
Activation Date: February 28, 2014

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

PA2

Phase III Adjuvant Trial In Pancreatic Cancer Comparing (1) 5FU And D-L Folinic Acid Vs (2) Gemcitabine Vs (3) No Adjuvant Treatment

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

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

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

Chairs: (Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4666
(Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4666

PA3

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

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

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

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

Chairs: (Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4666
(Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4666

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 0-2 (lead group may consider removing ECOG 2 at our request) - 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 . 1500 calories per day - free of significant nausea and vomiting - Adequate hematologic function - Adequate liver function (bilirubin . 1.5 times the institutional upper limit of normal) - Creatinine clearance > 50 mL/mn - Interval since the surgery between 21 and 56 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)

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

NCT Registration ID (from clinicaltrials.gov): 2011-002026-52
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(UNICANC)
Status: Open
Activation Date: July 18, 2012

Chairs: (Canada) Dr. James Biagi, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 4503
(Canada) Dr. Alice C. Wei, Univ. Health Network, 1(416) 340-4232

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) 235-3141

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

HE1

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

Eligibility:

Objectives:

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


Chairs: (Canada) Dr. Laura Ann Dawson, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2125

GENITO-URINARY STUDIES

BL7

Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy

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

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

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

Chairs: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, 1(519) 685-8261
(Canada) Dr. Malcolm Moore, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4666

BL8

Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.

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

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

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

Chairs: (Canada) Dr. Lori Wood, QEII Health Sciences Centre, 1(902) 473-6106
(Canada) Dr. Fred Saad, CHUM - Hopital Notre-Dame, 1(514) 890-8000 Ext. 27466

BL10

MVAC in Organ-Confined Bladder Cancer Based on p53 Status.

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

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

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

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

BL11

A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder

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

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

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

Chairs: (Canada) Dr. Louis Lacombe, CHUQ - Hotel Dieu de Quebec, 1(418) 691-5O50

BL12

A Multicenter Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen

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

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

NCT Registration ID (from clinicaltrials.gov): NCT02033993
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NCIC CTG)
Status: Open
Activation Date: January 27, 2014

Chairs: (Canada) Dr. Srikala Sridhar, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-4501 Ext. 2520

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: Histologically-proven T2, T3 or T4a bladder ca requiring radical cystectomy. Pt must not have clinical stage consistent with low-risk of node mets (CIS only, T1) nor T4b (fixed lesion. There must be plans for cystectomy and LND w/in 28 days of registration by study-specific credentialed surgeon. Prior neoadjuvant chemo ok if completed w/in 70 days prior to planned cystectomy and pt recovered from associated toxicities. No prior pelvic irradiation. No evidence of visceral or nodal mets. Pt must be offered specimen banking. Pt must have Zubrod PS of 0-2 and be medically suitable for cystectomy. No other prior malignancy. Pts with predominantly small cell, squamous cell, or adenocarcinoma histologies are not eligible. Laparoscopic surgery is not allowed. No prior partial cystectomy for invasive bladder ca. Pts must not have received any prior pelvic surgery that would obviate a complete extended lymphadenectomy.

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: Open
Activation Date: January 15, 2014

Chairs: (Canada) Dr. Wassim Kassouf, McGill University - Dept. Oncology, 1(514) 934-8246

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

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

PR8

Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.

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

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

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

Chairs: (Canada) Dr. Bryan Donnelly, Tom Baker Cancer Centre, 1(403) 259-2676

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, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2155
(Canada) Dr. Neil Fleshner, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2155

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, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2155

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

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

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: Open
Activation Date: September 27, 2007

Chairs: (Canada) Dr. Charles Catton, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 2121
(Canada) Dr. Fred Saad, CHUM - Hopital Notre-Dame, 1(514) 890-8000 Ext. 27466

PR15

Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

Eligibility: . Histologically confirmed CaP . PSA < 20 ng /ml . TNM classification . T2b to T2c, GS < 8/10 or . T1c-T2a GS 7/10 or . T1c-T2a, GS less than or equal to 7/10, 10 less than or equal to PSA < 20 . Prostate volume less than or equal to 60 cc

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

NCT Registration ID (from clinicaltrials.gov): NCT01982786
Participation: Limited to invited centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Open
Activation Date: November 05, 2013

Chairs: (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, 1(418) 691-5264
(Canada) Dr. Douglas Andrew Loblaw, Odette Cancer Centre, 1(416) 480-4806

PR17

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

Eligibility:

Objectives: Primary endpoint: Overall survival

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


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

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 - Hopital Notre-Dame, 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(CALGB)
Status: Open
Activation Date: October 15, 2007

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, may have measurable Disease or Non-Measurable Disease. Patients cannot have had treatment with prior taxane-based chemotherapy for metastatic disease and cannot have received prior enzalutamide, abiraterone, or other novel antiandrogen or androgen synthesis inhibitor. Patients must maintain ongoing androgen deprivation therapy. No known or suspected brain metastases, no planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery, no structurally unstable bone lesions suggesting impending fracture, no history of seizure or any condition that may increase the patient's seizure risk; no history of TIA, no clinically significant cardiovascular disease, no GI disorder that negatively affects absorption, no major surgery within 4 weeks p rior to enrollment.

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: Planned


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, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2155

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.

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, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2155

REC1

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

Eligibility: Patients with advanced renal cell cancer.

Objectives:

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

Chairs: (Canada) Dr. Simon Tanguay, McGill University Health Centre, 1(514) 934-8295 Ext. 48309

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

GYNECOLOGIC STUDIES

CX4

Phase III trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/L with Erythropoietin Versus Above 100 g/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer

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

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

NCT Registration ID (from clinicaltrials.gov): NCT00017004
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(GOG)
Status: Closed
Activation Date: October 19, 2001 , Closing Date: January 17, 2004

Chairs: (Canada) Dr. Peter S. Craighead, Tom Baker Cancer Centre, 1(403) 521-3701

CX5

SHAPE TRIAL: Simple Hysterectomy And Pelvic node dissection in Early cervix cancer 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

Eligibility:

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: Open
Activation Date: August 02, 2012

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

CXC1

A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage 1B2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis.

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

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

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

Chairs: (Canada) Dr. Luis Souhami, Montreal General Hospital, 1(514) 934-8040 Ext. 43163
(Canada) Dr. Peter S. Craighead, Tom Baker Cancer Centre, 1(403) 521-3701

EN5

A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium

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

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

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

Chairs: (Canada) Dr. Himu Lukka, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Ext. 64701
(Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495

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, with one of the following postoperative FIGO stages and grade: 1. stage IB grade 3 with documented LVSI 2. stage IC or IIA grade 3 3. Stage IIB 4. stage IIIA or IIIC (IIIA based on cytology alone only eligible if grade 3) 5. stage IB or IC, stage II or stage III with serous or clear cell histology WHO-performance status 0-2; WBC . 3.0 x 109/L; Platelets . 100 x 109/L; Bilirubin . 1.5 x UNL; ASAT/ALAT . 2.5 x UNL; Written informed consent

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 04, 2008 , Closing Date: December 20, 2013

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

GT1

A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia

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

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

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

Chairs: (Canada) Dr. Diane Provencher, CHUM - Hopital Notre-Dame, 1(514) 890-8444

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

OV16

A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer

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

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

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

Chairs: (Canada) Dr. Paul J. Hoskins, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2365

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: (Canada) Dr. Mark S. Heywood, Clinical Research Unit at Vancouver Coastal, 1(604) 877-6000 Ext. 2367
(France) Dr. Eric Pujade-Lauraine, Hopital Hotel Dieu, 01133(1) 4234-8325

OV18

A Randomized Trial of Concurrent Cediranib [AZD2171] (with Platinum-Based Chemotherapy) and Maintenance Cediranib in Women with Platinum-Sensitive Relapsed Ovarian Cancer.

Eligibility: Females aged ? 18 years with previous histologically proven diagnosis of Epithelial ovarian carcinoma Fallopian tube carcinoma Primary serous peritoneal carcinoma requiring treatment with further platinum-based chemotherapy > 6 months after their last cycle of first-line therapy.Signed informed consent and ability to comply with the protocol. Ability to commence treatment within 2 weeks of randomisation. CT or MRI proven relapsed disease (measurable or non-measurable), more than six months since completion of first-line platinum-based chemotherapy. ECOG performance status 0-1d. Life expectancy more than 12 weeks. If there is a past history of a solid tumour (other than ovarian cancer), this must have been treated curatively more than five years ago with no evidence of recurrence. If prior anthracycline or chest radiotherapy, Left Ventricular Ejection Fraction (LVEF) > institutional lower limit of normal. Adequate bone marrow function.

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

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

Chairs: (Canada) Dr. Hal Hirte, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495
(UK) Dr. Jonathan Ledermann, Cancer Research UK & UCL Cancer Trials Centre, 01144(20) 7679-9898

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

OV21

Phase II/III Trial 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: Progression-Free Survival Safety and Dose Tolerance; Feasibility; Regimen Selection

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: Open
Activation Date: September 11, 2009

Chairs: (Canada) Dr. Helen J. MacKay, Univ. Health Network-Princess Margaret Hospital, (416) 946-2253
(USA) Dr. Deborah Kay Armstrong, Southwest Oncology Group, Operations Office, 1(410) 614-2743
(Spain) Ms. Ana Oaknin-Benzaquen, GEICO-Sociedad Espanola de Oncologia Medica (SEOM), 01134
(UK) Dr. Chris Gallagher, UCL Cancer Trials Centre, 01144
(Canada) Dr. Diane Provencher, CHUM - Hopital Notre-Dame, 1(514) 890-8444

OV23

DPX-Survivac Ovarian Cancer Vaccine Study: A Randomized Phase 2 Trial

Eligibility: - histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube, or peritoneal cancer - completed IV or IP neo-adjuvant and/or adjuvant treatment (up to 8 cycles) of paclitaxela nd carboplatin or other acceptable chemotherapy brfore and after debulking surgery - evidence of complete or partial response by radiological imaging or evidence of CT scan with < 1 cm disease and normal CA-125 at study entry - first vaccination must be started within 90 days of last dose of chemotherapy

Objectives: Primary: progression free survival Secondary: overall survival; biologic correlates

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


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

HEAD AND NECK STUDIES

HN3

A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck

Eligibility: Patients with squamous cell carcinoma of the oral cavity, pharynx (oro, hypo and naso), or larynx, who are to receive radiation treatment to a significant part of the oral and/or pharyngeal mucosa where the reaction will be visible.

Objectives: To compare the toxicity of radiotherapy to the oral mucosa delivered in the morning and the late afternoon; to compare grades and duration of mucositis, incidence of clinically significant mucositis using a validated mucositis scoring system, treatment days lost because of treatment reactions, incidence of late toxicity, changes in body weight, complete response rates, survival and quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00004234
Participation: Not limited
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Closed
Activation Date: August 02, 1999 , Closing Date: November 15, 2004

Chairs: (Canada) Dr. Georg A. Bjarnason, Odette Cancer Centre, 1(416) 480-6100 Ext. 5847
(Canada) Dr. Robert G. MacKenzie, Odette Cancer Centre, 1(416) 480-4974

HN4

A Phase II Study of Cisplatin and Gemcitabine in Patients with Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumours

Eligibility: Patients will have documented evidence of locally advanced recurrent and/or metastatic malignant salivary gland tumours deemed to be incurable by surgery or radiation. Patients may have had up to one prior chemotherapy regimen for locally advanced recurrent/metastatic disease provided that it was non cisplatin/carboplatin or gemcitabine containing and at least 4 weeks have elapsed since chemotherapy discontinuation and study registration. Adjuvant chemotherapy (including cisplatin or carboplatin based regimens) is allowed provided that a minimum of 12 months has elapsed.

Objectives: Primary: To estimate the activity of combination cisplatin (or carboplatin) and gemcitabine among patients with malignant salivary gland tumours which are locally recurrent or metastatic. Secondary: Measurement of complete response Measurement of duration of response Assessment of the toxicity profile of the combination regimen Measurement of overall survival

NCT Registration ID (from clinicaltrials.gov): NCT00079079
Participation: Limited to invited centres only.
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Closed
Activation Date: October 23, 2003 , Closing Date: May 05, 2008

Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911

HN5

A Phase I Study of Adjuvant OSI-774 (Tarceva) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Eligibility: Patients with locally advanced squamous cell carcinoma of the head and neck (stages III, IVA or IVB) post treatment with combined chemo-radiotherapy (cisplatin based). Patients must have no evidence of disease or presence of inoperable minimal residual disease at the time of registration.

Objectives: To evaluate the toxicity and determine the recommended dose of OSI-774. To evaluate the effect(s) of OSI-774 on plasma and urinary angiogenic factors (specifically VEGF, VEGFR, VEGFR2, bFGF levels) before, during and after therapy. To correlate angiogenic factor levels with initial blood vessel concentration in the tumour and with the presence or absence of EGFRvIII mutation. To document disease free survival (DFS).

NCT Registration ID (from clinicaltrials.gov): NCT00079053
Participation: Limited to invited centres only.
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Closed
Activation Date: November 05, 2003 , Closing Date: March 31, 2008

Chairs: (Canada) Dr. Denis Soulieres, CHUM - Hopital Notre-Dame, 1(514) 890-8000 Ext. 25381

HN6

A Phase III Study Of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab In Patients With Locally Advanced Stage III And IV Squamous Cell Carcinoma Of The Head And Neck.

Eligibility: Patients with histologically confirmed squamous cell carcinoma of the head and neck of the oral cavity, oropharynx, larynx or hypopharynx which is locally advanced as defined by TanyN+M0 or T3-4N0M0.

Objectives: The primary objective is progression free survival. The secondary objectives include: overall survival, local progression free survival, regional progression free survival, distant metastasis, acute and late adverse events, quality of life, swallowing related quality of life, functional swallowing outcome (selected centres), significance of tissue and blood biomarkers, and health economics.

NCT Registration ID (from clinicaltrials.gov): NCT00820248
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Closed
Activation Date: December 18, 2008 , Closing Date: November 07, 2011

Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911
(Canada) Dr. John Waldron, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-6522

HEMATOLOGIC STUDIES

AL3

Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia

Eligibility: Diagnosis of acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by RT-PCR assay. Prior treatment: No systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient. Non-pregnant, non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Patients should not become pregnant or plan to become pregnant while on treatment.

Objectives: To compare the efficacy (event-free survival) and toxicities of two induction/consolidation therapies for patients with untreated APL: ATRA/ara-C/daunorubicin with or without arsenic trioxide (AS2O3). To evaluate the efficacy (disease-free survival) and toxicities of maintenance therapy with intermittent ATRA versus intermittent ATRA plus 6-MP/MTX for patients with APL who achieve a complete response.

NCT Registration ID (from clinicaltrials.gov): NCT00003934
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(CALGB)
Status: Closed
Activation Date: April 18, 2002 , Closing Date: March 29, 2005

Chairs: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, 1(902) 473-8562
(Canada) Dr. Stephen Couban, QEII Health Sciences Centre, 1(902) 473-8562

AL4

A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol

Eligibility: Patients must have pathologically documented de novo acute lymphoblastc leukemia, excluding mature B-cell ALL, which is diagnosed by the presence of either surface immunoglogulin, L3 morphology or one of the following cytogentic abnormalities t(8;14)(q24;q32), t(8;22), or t(2;8).

Objectives: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. To determine the safety and optimal dosing of L-asparaginase during the intensification period. To determine the pharmacokinetics of weekly E.coli L-asparaginase by evaluating serum asparaginase levels in all patients To determine the toxicity of individualized dosing of E.coli L-asparaginase based upon asparaginase levels To determine the prognostic significance of early response to induction chemotherapy within the context of our treatment program To evaluate the outcome of patients based upon bone marrow status after 15 days of multi-agent induction chemotherapy, comparing the outcome of patients with M3 status (>25% leukemia cells still present) at that time point versus those with M1/M2 status (<25% leukemia cells still present) or hypoplastic marrows. To evaluate the outcome of patients base

NCT Registration ID (from clinicaltrials.gov): NCT00136435
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(DFCI)
Status: Closed
Activation Date: January 24, 2005 , Closing Date: February 21, 2008

Chairs: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, 1(902) 473-8562
(Canada) Dr. Stephen Couban, QEII Health Sciences Centre, 1(902) 473-8562

AL5

DFCI 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

ALC1

A Phase III Study Of The Addition Of Mylotarg? During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg? Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia

Eligibility: Patients must have a morphologically confirmed diagnosis of acute myeloid leukemia (AML) with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration.

Objectives: -Compare DFS of patients under age 56 with previously untreated, de novo, non-M3, AML who receive Mylotarg as post-consolidation therapy versus patients who receive no post-consolidation therapy. -Compare CR rate achieved by the addition of Mylotarg to standard induction chemotherapy in patients under the age of 56 with previously untreated, de novo, non-M3 AML. The durability of complete response will also be measured. -Estimate the frequency and severity of toxicities of the addition of Mylotarg to induction therapy and post-consolidation therapy. -To evaluate the prognostic significance of CD33 expression on the response rate of patients who receive Mylotarg. -To evaluate the prognostic significance of FLT3 mutations and flow through cytometic detection prior to therapy, and of minimal residual disease in remission specimens collected before and after consolidation therapy and after post-consolidation therapy with Mylotarg.

NCT Registration ID (from clinicaltrials.gov): NCT00085709
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: April 27, 2006 , Closing Date: August 20, 2009

Chairs: (Canada) Dr. Thomas J. Nevill, Vancouver General Hospital, 1(604) 875-4863

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 Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat in Younger Patients with Previously Untreated 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: Open
Activation Date: September 10, 2013

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

CL2

A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia

Eligibility: Patients with previously untreated B-cell chronic lymphocytic leukemia, requiring treatment. Submission of blood samples for immunophenotyping, FISH and PCR studies are a requirement for participation.

Objectives: To determine overall (CR, PR) response rate. Secondary endpoints include assessment of molecular CR rate, toxicity, progression-free and treatment-free survival as well as determination of the incidence of defined genetic abnormalities in the study population. The prognostic and predictive significance of genetic abnormalities and immunophenotypic profile at the start of treatment, with respect to response to oral fludarabine, will be evaluated.

NCT Registration ID (from clinicaltrials.gov): NCT00049075
Participation: Limited to centres expecting to accrue > 4 patients/year
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Closed
Activation Date: August 08, 2002 , Closing Date: January 30, 2004

Chairs: (Canada) Dr. Chaim Shustik, Royal Victoria Hospital, 1(514) 398-1444

CL3

A Genetic, Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients with Symptomatic Previously Untreated Chronic Lymphocytic Leukemia

Eligibility: B-cell chronic lymphocytic leukemia (CLL); Creatinine ? 1.5 x ULN; Lymphocytosis > 5,000/?L with < 55% prolymphocytes; Bone marrow aspirate with > 30% of all nucleated cells being lymphoid or bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; Overall cellularity must be normocellular or hypercellular; Monoclonal B-cell population that is positive for ? 1 B-lineage markers (CD19, CD20, CD23) with co-expression of CD5 (bright surface immunoglobulin patients must co-express CD23): Symptomatic and active intermediate risk (lymphadenopathy and/or hepatosplenomegaly) or high risk (Hgb < 11 g/dL or platelets < 100,000/?L) category of modified Rai staging system; No prior therapy for CLL; No medical condition requiring chronic use of oral corticosteroids; Age ? 18 years; Performance Status 0 - 2; HIV patients may be eligible if the criteria are met; Non-pregnant and non-nursing

Objectives: Progression free survival

NCT Registration ID (from clinicaltrials.gov): NCT00602459
Participation: Limited to invited centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(CALGB)
Status: Closed
Activation Date: January 13, 2009 , Closing Date: August 17, 2012

Chairs: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, 1(902) 473-8562

CLC1

A Phase III Intergroup CLL Study of Asymptomatic, Untreated Chronic Lymphocytic Leukemia Patients Randomized to Early Intervention versus Observation in the High Risk Genetic Subset with IG VH Un-mutated Disease

Eligibility: Patients must be within 6 motnhs of the initial flow cytometric confirmation of b-cell chronic lymphocytic leukemia (CLL). This interval begins with the intial flow cytometric conformation of disease. Clinical and immunophenotypic documentation of CLL including: - Lymphocytosis >5000 uL with <55% prolymphocytes - Monoclonal B-cell population is positive for > 1 B-lineage marker (CD19, CD20, CD23) with co-expression of CD5. Patients with bright surface immunoglobulin levels must have CD23 co-expression and absence of t(11:14)on interphase sytogenetics or have negative tumor protein staining for cyclin D1. Asymptomatic low risk category of modified Rai staging system (Rai stage 0-1). No prior therapy for CLL including corticosteroids; Age > 18yrs; Performance status 0-1; No HIV disease; Non-pregnant and non-nursing.

Objectives: To determine if early treatment with chemoimmunotherapy extends the time to second treatment (TT2T), and overall survival in genetically high-risk (un-mutated Ig VH), newly diagnosed, asymptomatic CLL patients.

NCT Registration ID (from clinicaltrials.gov): NCT00513747
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(CALGB)
Status: Closed
Activation Date: July 18, 2008 , Closing Date: December 24, 2009

Chairs: (Canada) Dr. Matthew D. Seftel, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2262

CLC2

A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (65 Years of Age) with Chronic Lymphocytic Leukemia (CLL).

Eligibility:

Objectives:

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: Planned


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

CM1

A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.

Eligibility: Patients with chronic phase CML are eligible based on bone marrow aspirate, biopsy and peripheral blood counts obtained within 14 days before registration. Patients must have confirmed Philadelphia chromosome or variants of the (9-22) translation by cytogenetics or by FISH or be positive for BCR-ABL by RT-PCR. Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosomes. Patients must have a Zubroid performance status of 0 - 2. Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide. Patients must not have received prior chemotherapy for peripheral blood stem cell mobilization.

Objectives: 1.1 To test whether increasing the dose of imatinib (STI571, Gleevec?) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase. 1.2 To estimate rates of cytogenetic and hematologic responses to each of the two imatinib dose levels. 1.3 To evaluate in a preliminary manner the prognostic effects of der(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib. 1.4 To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment. 1.5 To estimate the frequency and severity of toxicities of the two treatment regimens.

NCT Registration ID (from clinicaltrials.gov): NCT00070499
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: September 30, 2005 , Closing Date: February 28, 2009

Chairs: (Canada) Dr. Jeffrey H. Lipton, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 2268

HD7

A Randomized Phase III Trial of ABVD Versus Stanford V With or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease

Eligibility: Previously untreated patients with histologically proven Hodgkin?s disease (HD). The diagnosis should be made by excisional biopsy whenever possible, but fine needle aspirate may suffice if 1) the morphology is unequivocal and 2) immunohistochemical studies are consistent with the diagnosis of HD. ECOG performance status must be 0 - 2.

Objectives: To compare the failure-free survival in patients with locally extensive and advanced stage Hodgkin?s disease treated with standard ABVD chemotherapy versus patients given Stanford V chemotherapy ? radiotherapy. To assess overall survival and freedom from progression in these patients at 5 and 10 years. To assess secondary endpoints: pulmonary function, incidence of second cancers, reproductive function (baseline and 5 years) and deaths from causes other than Hodgkin?s disease.

NCT Registration ID (from clinicaltrials.gov): NCT00003389
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ECOG)
Status: Closed
Activation Date: June 07, 2000 , Closing Date: June 15, 2006

Chairs: (Canada) Dr. Joseph M. Connors, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746

HD8

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

Eligibility: Patients will receive either 4 cycles of escalated BEACOPP and 4 cycles of baseline or 8 cycles of ABVD.

Objectives: To compare the effect of BEACOPP versus Standard ABVD regimen does the BEACOPP regimen improve event free survival when compared to the 8 cycles of the standard ABVD regimen in patients with measurable stage III or IV Hodgkin's disease with IPS score of 3 or higher.

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

LY7

Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma. A Phase III Randomized Clinical Trial

Eligibility: Patients with stage III or IV follicular non-Hodgkin's lymphoma (at initial diagnosis) who have relapsed after a maximum of two non-anthracycline containing systemic chemotherapy regimens. Lymphoma must be CD20 positive.

Objectives: To establish the effect of addition of rituximab to CHOP chemotherapy on the response rate and quality of remission in relapsed low grade non-Hodgkin's lymphoma To establish the effect of maintenance treatment with rituximab on progression free survival in relapsed low grade non-Hodgkin's lymphoma in remission after CHOP ? rituximab.

NCT Registration ID (from clinicaltrials.gov): NCT00004179
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(EORTC)
Status: Closed
Activation Date: May 15, 2000 , Closing Date: February 06, 2004

Chairs: (Canada) Dr. Richard J. Klasa, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2249

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

LY11

A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups

Eligibility: Patients must have biopsy proven intermediate or high grade non-Hodgkin's lymphoma (Working Formulation groups D through H and J) except lymphoblastic lymphoma (Working Formulation group I). Transformed lymphomas are not eligible. Mantle cell lymphomas are considered to be Working Formulation group E, but are ineligible for this study.

Objectives: To compare in a cooperative group setting the overall survival and progression free survival of patients in the age adjusted High-Intermediate and High Risk Prognostic Groups of the International Classification with diffuse aggressive non-Hodgkin?s lymphomas who are treated on a randomized trial that compares standard conventional chemotherapy to an abbreviated course of induction chemotherapy followed by early transplantation. To compare the toxicity of these treatment strategies.

NCT Registration ID (from clinicaltrials.gov): NCT00004031
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(SWOG)
Status: Closed
Activation Date: November 28, 2001 , Closing Date: December 15, 2007

Chairs: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, 1(902) 473-8562
(Canada) Dr. Stephen Couban, QEII Health Sciences Centre, 1(902) 473-8562

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): NCT0078949
Participation: Not limited.
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NCIC CTG)
Status: Closed
Activation Date: August 07, 2003 , Closing Date: December 31, 2012

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

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

LY15

A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma.

Eligibility: Patients enrolled in this study must have histologically confirmed peripheral T cell lymphoma (PTCL) or diffuse large B cell lymphoma, and must have received one or two previous treatment regimens (histologic proof of disease by biopsy is mandatory). There must be clinically or radiologically measurable disease at baseline.

Objectives: - To evaluate the safety and feasibility of the combination of gemcitabine, dexamethasone and cisplatin (GDP) and romidepsin in relapsed/refractory aggressive lymphomas (including PTCL and DLBCL). - To identify the maximum tolerated doses of romidepsin, gemcitabine, dexamethasone and cisplatin used in combination. - To evaluate preliminary evidence of anti-tumour activity. - To establish a recommended phase II dose of romidepsin to be given in combination with GDP in a planned randomized phase II trial in newly diagnosed untreated PTCL.

NCT Registration ID (from clinicaltrials.gov): NCT01846390
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Open
Activation Date: April 30, 2013

Chairs: (Canada) Dr. Anthony J. Reiman, Atlantic Health Sciences Corporation, 1(506) 648-6884
(Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2641

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: Open
Activation Date: June 17, 2013

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

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: Open
Activation Date: March 12, 2014

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

MY7

A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients

Eligibility: Patient with newly diagnosed, histologically proven, untreated, symptomatic Stage I or Stage II or III myeloma, with either a measurable serum M-protein or Bence Jones M-protein of >1.0g/24h and an ECOG performance status of <4.

Objectives: To Compare overall survival between patients receiving M+P versus M+D as induction therapy and patients maintained by dexamethasone versus observation. To compare time progression, response rates, incidences of toxicities and quality of life with the same groups of patients.

NCT Registration ID (from clinicaltrials.gov): NCT00002678
Participation: Not limited
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: NCIC CTG
Status: Closed
Activation Date: June 02, 1995 , Closing Date: July 16, 2003

Chairs: (Canada) Dr. Chaim Shustik, Royal Victoria Hospital, 1(514) 398-1444

MY10

A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma

Eligibility: Patients with histologically confirmed myeloma who had had an autologous stem cell transplant within one year of the beginning of initial treatment for their disease. Patients must be randomized within 60-100 days post transplant and have no other medical condition precluding long term use of prednisone or thalidomide.

Objectives: Primary: to determine if maintenance treatment post transplant with thalidomide and prednisone (TP) prolongs overall survival compared with observation alone. Secondary: to determine if TP prolongs progression-free survival compared with observation alone; to compare quality of life, toxic effects, and the incidence of venous thromboembolism between the two patient groups. Correlative Studies Endpoints: to correlate FISH-identified chromosome translocations at relapse with clinical outcome in the two patient groups; to determine if there is evidence of increased thrombin generation in patients receiving TP as compared with those not.

NCT Registration ID (from clinicaltrials.gov): NCT00049673
Participation: Not limited
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(NCIC CTG)
Status: Closed
Activation Date: September 16, 2002 , Closing Date: January 30, 2009

Chairs: (USA) Dr. Keith Stewart, Mayo Clinic, 1(480) 301-4411
(USA) Dr. Keith Stewart, Mayo Clinic, 1(480) 301-4411
(USA) Dr. Martha Q. Lacy, Mayo Clinic Rochester, 1(507) 284-8430

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

MDC1

A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) versus Azacitidine Alone versus 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: Open
Activation Date: November 22, 2012

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

LUNG STUDIES

BR15

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

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

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

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

Chairs: (Canada) Dr. Yee C. Ung, Odette Cancer Centre, 1(416) 480-4951

BR15C

This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

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

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

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

Chairs: (Canada) Dr. Yee C. Ung, Odette Cancer Centre, 1(416) 480-4951

BR16

Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer

Eligibility: Patients who have undergone complete resection of a histological proven stage 1A or 1B non-small cell lung cancer who are currently free of disease. Centres currently participating on BR.10 may not randomize patients with stage T2N0 until BR.10 closes to accrual.

Objectives: To evaluate the efficacy of selenium supplementation in reducing the incidence of second primary lung tumours in patients who have been treated for Stage 1 non-small cell lung cancer with complete surgical resection. To evaluate the qualitative and quantitative toxicity of selenium supplementation in a daily administration schedule. To compare the incidence of specific cancers and mortality from cancer as well as overall survival of patients treated with selenium supplementation versus patients treated with placebo.

NCT Registration ID (from clinicaltrials.gov): NCT00008385
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? No
Coordination: Intergroup(ECOG)
Status: Closed
Activation Date: November 23, 2000 , Closing Date: November 05, 2009

Chairs: (Canada) Dr. Michael R. Johnston, QEII Health Sciences Centre, 1(902) 473-2281

BR17

Phase III Study of Tomudex and Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma

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

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

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

Chairs: (Canada) Dr. Mark D. Vincent, London Regional Cancer Program, 1(519) 685-8640
(Belgium) Dr. Veerle Evrard, EORTC Data Center, 01132(2) 774-1087

BR18

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

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

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

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

Chairs: (Canada) Dr. Michael Smylie, Cross Cancer Institute, 1(780) 432-8757
(Canada) Dr. Natasha Leighl, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-4645
(Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4522
(Canada) Dr. Natasha Leighl, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-4645
(Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4522

BR19

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

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

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

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

Chairs: (Canada) Dr. Glenwood Goss, Ottawa Health Research Institute - General Division, 1(613) 737-8899 Ext. 73955
(USA) Dr. Katherine Pisters, M.D. Anderson Cancer Center, 1
(USA) Dr. James R. Jett, NCCTG, Mayo Clinic, 1(507) 284-3764
(USA) Dr. Martin J. Edelman, Univ. of Maryland - Greenebaum Cancer Centre, 1(410) 328-2703
(USA) Dr. Fadlo R. Khuri, Emory University/ Winship Cancer Institute (RTOG), 1(404) 778-4250
(USA) Dr. Hak Choy, , 1(214) 645-7600
(USA) Dr. Peter Roberts, (SWOG) US Naval Medical Center, 1(757) 953-2451
(USA) Dr. Greg Masters, Medical Oncology Hematology Consultants, PA, 1(302) 366-1200

BR20

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

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

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

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

Chairs: (Canada) Dr. Andrew Arnold, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Ext. 64613

BR21

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

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

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

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

Chairs: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4522
(Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4522

BR22

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

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

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

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

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

BR22C

This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

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

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

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

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

BR23

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

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

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

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

Chairs: (Canada) Dr. Thomas Waddell, Univ. Health Network-The Toronto General Hospital, 1(416) 340-3432
(Canada) Dr. Gad A. Perry, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70215
(Canada) Dr. Scott Laurie, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70173

BR23C

This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

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

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

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

Chairs: (Canada) Dr. Thomas Waddell, Univ. Health Network-The Toronto General Hospital, 1(416) 340-3432

BR24

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

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

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

NCT Registration ID (from clinicaltrials.gov): NCT00245154
Participation: Limited to invited centres only.
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Closed
Activation Date: September 07, 2005 , Closing Date: February 25, 2008

Chairs: (Canada) Dr. Scott Laurie, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70173
(Canada) Dr. Glenwood Goss, Ottawa Health Research Institute - General Division, 1(613) 737-8899 Ext. 73955

BR25

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

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

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

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

Chairs: (Canada) Dr. Patrick C.F. Cheung, Odette Cancer Centre, 1(416) 480-6165
(Canada) Dr. Sergio Luiz Faria, Montreal General Hospital, 1(514) 934-8040

BR26

A Double Blind Placebo Controlled Randomized Trial of PF-00299804 (PF-804) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease

Eligibility: Advanced previously treated Non-Small Cell Lung Cancer

Objectives: Progression free survival and Overall survival

NCT Registration ID (from clinicaltrials.gov): NCT01000025
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: NCIC CTG
Status: Closed
Activation Date: September 04, 2009 , Closing Date: June 13, 2013

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

BR28

Concurrent Once-Daily Versus Twice-Daily Radiotherapy: A 2-Arm Randomised Controlled Trial Of Concurrent Chemo-Radiotherapy Comparing Twice-Daily And Once-Daily Radiotherapy Schedules In Patients With Limited Stage Small Cell Lung Cancer (SCLC) And Good Performance Status.

Eligibility: Limited stage Small cell lung cancer

Objectives: Overall survival Local progression-free survival; Metastasis-free survival; CTCAE v3.0 toxicity; Cytotoxic dose intensity; Radiotherapy dose intensity; Prospective cost-effectiveness analysis.

NCT Registration ID (from clinicaltrials.gov): NCT00433563
Participation: Open to member centres
NCI US Affiliation? No
Clinical Trials Application (Canada)? No
Coordination: Intergroup(MLG)
Status: Closed
Activation Date: December 09, 2008 , Closing Date: July 22, 2013

Chairs: (Canada) Dr. Andrea Bezjak, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2132

BR29

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

Eligibility:

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

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

Chairs: (Canada) Dr. Scott Laurie, Ottawa Health Research Institute - General Division, 1(613) 737-7700 Ext. 70173
(Australia) Dr. Benjamin Solomon, Peter McCallum Cancer Institute, 01161(131) 9656-1517
(Australia) Dr. Martin Stockler, Royal Prince Alfred Hospital, 01161(2) 9515-5494

BRC1

A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer

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

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

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

Chairs: (Canada) Dr. Alexander Y. Sun, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-2126

BRC2

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB-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: To evaluate Overall Survival with chemotherapy with or without bevacizumab used in the adjuvant setting for resected stage IB-IIIA NSCLC.

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. Charles Butts, Cross Cancer Institute, 1(780) 432-8513
(Canada) Dr. Natasha Leighl, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-4645

BRC2E

A Prospective Economic Analysis of NCIC CTG BRC.2/E 1505. A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab For Patients With Completely Resected Stage 1B-IIIA Non-Small Cell Lung Cancer.

Eligibility: All Canadian patients registered to BRC.2.

Objectives: 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.

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, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-4645

BRC4

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

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

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

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

Chairs: (Canada) Dr. Geoffrey Liu, Univ. Health Network-Princess Margaret Hospital, 1(416) 946-4501 Ext. 3428

BRC5

A Phase III Trial of Lobectomy Versus Sub Lobular Resection For Small (<2cm) Peripheral Non-Small Cell Lung Cancer.

Eligibility: Non Small Cell Lung Cancer - Stage 1

Objectives: Overall survival Progression-free survival; Toxicity; QoL; Correlative molecular markers; Economic Analysis

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

Chairs: (Canada) Dr. Jean Deslauriers, University Institute of Cardiology and, 1(418) 656-4747

MELANOMA STUDIES

ME10

Phase III Randomized Study of Four Weeks High Dose IFN-ALPHA2b In Stage T2bNo, T3a-bNo, T4a-bNo, and T1-4, N1a,2a,3 (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

ME11

Adjuvant Peginterferon alfa-2b For 2 Years vs Observation in Patients with an Ulcerated Primary Cutaneous Melanoma with T(2-4)bN0M0: A Randomized Phase III Trial of the EORTC Melanoma Group

Eligibility: -Subjects must have histologically documented ulcerated primary cutaneous melanoma with a Beslow thickness >1mm that has been excised radically 3 months prior to randomization. Excision margins of at least 1 cm are required. In the head and neck areas and in case of locations distally on extremities narrower margins are acceptable as long as they are radical. - In case subjects have undergone Sentinel Node staging after the excision of the primary, this must be done within the time frame of 3 months between the date of final excision of the primary and the date of randomization. - Subjects must have an ECOG performance status of 0 or 1. - Subjects must be between 18-70 years old. - Subjects must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 4 weeks prior to initiation of study treatment. - Subjects must give informed consent according to ICH-GCP or national/local policy.

Objectives: Primary - Relapse Free Survival Secondary - Distant metastases free survival; Overall survival; toxicity; QoL

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


Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-5248

ME12

Melanoma Margins Trial (MelMarT)

Eligibility: Patients with cutaneous melanoma >1mm Breslow thickness

Objectives: Primary: Local recurrence rate; melanoma-specific survival Secondary: Regional recurrence rate; surgical complications; duration of hospital stay; QoL and Health economics

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


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). " Among patients enrolled by CCOPs, to compare the global QOL between the ipilimumab arms versus HDI using FACT-G fo

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: Open
Activation Date: October 02, 2012

Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-5248

SARCOMA STUDIES

SR3

Randomized phase III trial of adjuvant chemotherapy with high-dose doxorubicin ifosfamide and lenograstim in high grade soft tissue sarcoma (EORTC: 62931)

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

SRC1

A Phase III Randomized Double-Blind Study of Adjuvant STI571 Gleevec TM Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST)

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

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

NCT Registration ID (from clinicaltrials.gov): NCT00041197
Participation: Open to member centres
NCI US Affiliation? Yes
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(ACOSOG)
Status: Closed
Activation Date: October 04, 2002 , Closing Date: April 18, 2007

Chairs: (Canada) Dr. Martin Blackstein, Mount Sinai Hospital, 1(416) 586-5371

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

SR6

A Randomized Phase III, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

Eligibility:

Objectives:

NCT Registration ID (from clinicaltrials.gov): NCT01440088
Participation:
NCI US Affiliation? No
Clinical Trials Application (Canada)? Yes
Coordination: Intergroup(SARC)
Status: Closed
Activation Date: July 20, 2012 , Closing Date: December 26, 2013

Chairs: (Canada) Dr. Thierry Alcindor, McGill University - Dept. Oncology, 1(514) 934-1934 Ext. 43118

SYMPTOM CONTROL STUDIES

SC18

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

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

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

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

Chairs: (Canada) Dr. Neil MacDonald, McGill University, Gerald Bronfman Centre, 1(514) 398-8988

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, Univ. Health Network-Princess Margaret Hospital, 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: (USA) Dr. William Hartsell, Advocate Good Samaritan Cancer Center, 1(630) 275-2300
(Canada) Dr. Jackson Wu, Tom Baker Cancer Centre, 1(403) 521-3095
(Canada) Dr. Edward L.W. Chow, Odette Cancer Centre, 1(416) 480-4998
(UK) Dr. Peter Hoskin, Univ. College of London Clinical Trials Unit, 01144(1923) 844533
(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
(France) Dr. Jean-Leon Lagrange, Hopital Henri Mondor, 01133(14) 981-4524

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.

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

SC22

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

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

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

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

Chairs: (Canada) Dr. Bruno Gagnon, McGill University Hospital Centre - RVH, 1(514) 843-1564
(Canada) Dr. Ray Viola, Queen's University, 1(613) 549-6666 Ext. 3223

SC23

A Randomized 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: Open
Activation Date: November 22, 2010

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

SC24

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

Eligibility:

Objectives:

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


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

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