Gastro-Intestinal Disease Site

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


Complexity Level: 3

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

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

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

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


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

Complexity Level: 3

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

Objectives: Protocol specified organ preservation rate

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

Chair: (USA) Dr. Hagen Kennecke, Virginia Mason Medical Center, (206) 223-6600, (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 72791


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

Complexity Level: 2

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

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

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

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


Closed to Accrual
I208Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination with Panitumumab in Patients with Metastatic or Advanced RAS-Wild Type Colorectal Cancer.
The main purpose of this study is to determine the recommended dose of BKM120 in combination with panitumumab therapy and to determine the safety, tolerability, adverse events (side effects) and dose limiting events of BKM120 and panitumumab. Additional research will investigate tissue samples from previously removed melanoma lesions by looking and response rates and early progression rates and the correlation, if any between response and certain biomarkers in the archival tumour tissue.

Complexity Level: 1

Eligibility: Patients with histologic proof of a primary colorectal cancer which is recurrent or metastatic. Tumour must be K-Ras wild type by means of mutation analysis and patient must have a representative sample of tumour tissue available. Patient must have failed, or have been unable to receive prior irinotecan, oxaliplatin and thymidylate synthase inhibitor therapy. Phase I-patients may have measureable or non-measurable disease. Phase II-patients must have measureable disease. At least 4 weeks since major surgery, chemotherapy, investigational agent or radiation therapy. ECOG 0-2. Age > 18 years.

Objectives: Phase I-To determine the recommended phase II dose of BKM120 in combination with standard panitumumab therapy and determine the safety, tolerability, toxicity profile and dose limiting toxicities. Phase II-To assess the anti-tumour activity as evidenced by response rates and early progression and investigate the correlation, if any, between response and molecular biomarkers in archival FFPE tumour.

NCT Registration ID (from clinicaltrials.gov): NCT01591421
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: May 01, 2012 Closing Date: July 14, 2015

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

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

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

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

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


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


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

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


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

Chair: (USA) Dr. Henry C. Pitot, Mayo Foundation, (507) 284-3903


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


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

Chair: (Canada) Dr. Christine Cripps, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70176


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


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

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

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

Chair: (USA) Dr. Heidi Nelson, Mayo Clinic, (507) 284-3329


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

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

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

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

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


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

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

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

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

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

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

Chair: (Canada) Dr. Renaud Whittom, Hopital du Sacre-Coeur de Montreal, (514) 338-2050


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

Complexity Level: 2

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

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

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

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


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

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

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

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

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168


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


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

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

Complexity Level: 2

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

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

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

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


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


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

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


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

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


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

Chair: (Canada) Dr. Lois Shepherd, Canadian Cancer Trials Group, Queen's University, (613) 533-6430 Ext. 77714


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


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

Chair: (Canada) Dr. Bernard Cummings, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2129


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


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

Chair: (Belgium) Dr. Harry Bleiberg, Institut Jules Bordet, (2) 541-3196, (Italy) Dr. Silvia Marsoni, SENDO (Southern Europe New Drug Organ), (2) 764-2041, (Italy) Dr. R. Labianca, Lab of Clinical Epidemiology(2)


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


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

Chair: (Canada) Dr. Barbara J. Fisher, London Regional Cancer Program, (519) 685-8650


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


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

Chair: (USA) Dr. Michael J. O'Connell, Allegheny General Hospital, (412) 359-8208


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


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

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


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

Chair: (USA) Dr. Michael J. O'Connell, Allegheny General Hospital, (412) 359-8208


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


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

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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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

Complexity Level: 2

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

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

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

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

Complexity Level: 2

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

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

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

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


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

Complexity Level: 2

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

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

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

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


Permanently Closed
I112NCIC CTG Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Locally Advanced or Metastatic Colorectal Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 11, 1998 Closing Date: September 29, 1999

Chair: (Canada) Dr. Christine Cripps, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70176


Permanently Closed
I135A Phase I/II Study Of CPT-11 (Irinotecan), Oxaliplatin and Raltitrexed (COT) in Patients With Advanced Colorectal Cancer


Eligibility: Histologically documented colon or rectal cancer that is metastatic or locally recurrent.

Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of COT given as intravenous infusions on day 1 every 3 weeks. To determine the toxic effects of COT. To determine the pharmacokinetics IF the toxicity of the combined regimen is not in keeping with the toxicity expected from single or double agent studies. To assess clinical response rates of the combination.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 28, 2000 Closing Date: February 07, 2002

Permanently Closed
I146A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
The purpose of this study is to find out what effects the experimental drug SarCNU has on bowel cancer. In addition, this study will evaluate the side effects of SarCNU. This research is being done because SarCNU has not been tested in bowel cancer and it comes from a family of drugs which are known to be effective in some patients.

Eligibility: Histologically proven colorectal cancer, either locally recurrent or metastatic following first-line chemotherapy for recurrent/metastatic disease. Clinically or radiological documented unidimensional measurable disease (RECIST criteria). Must have received one previous chemotherapy regimen for recurrent/metastatic disease. Prior nitrosourea not permitted.

Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent/metastatic colorectal cancer. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

NCT Registration ID (from clinicaltrials.gov): NCT00028015
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 30, 2001 Closing Date: August 14, 2003

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


Permanently Closed
I168A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
The purpose of this study is to find out what effects an experimental drug, SB-715992, will have on primary liver cancer (hepatocellular carcinoma). In addition this study will evaluate the side effects of SB-715992, its blood levels, and in some patients who consent to special laboratory studies, the effect of the drug in white blood cells. As well, researchers will look at tumour tissue samples (samples from patients who have had liver cancer tissue previously removed) to learn about which types of primary liver cancer are most likely to be affected by SB-715992. Patients who meet all of the eligibility criteria will be given SB-715992 by needle into a vein once every 3 weeks.

Eligibility: Patients with histologically or cytologically documented hepatocellular carcinoma with locally advanced, recurrent or metastatic disease. Unidimensionally measurable disease by RECIST criteria. Prior intra-hepatic chemotherapy permitted; no prior systemic chemotherapy permitted. Patients must be > 4 weeks since major surgery, radiation therapy, local ablative therapy or intra-hepatic chemotherapy and must have hepatic reserve of Child-Turcotte-Pugh Class A or better. Patients with histological diagnosis must have archival tumour specimen available for correlative study.

Objectives: To assess the efficacy (response rate and stable disease rate) of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma. To assess the toxicity of SB-715992 in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma, as well as early progression rate, and, if responses are observed, response duration. To characterize the population pharmacokinetic (PK) parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints. To describe the relationship between tumour expression of B-tubulin and KSP in archival paraffin fixed tumour tissue with clinical outcome of treatment with SB-715992. In a subset of separately consenting patients, to describe the changes in molecular markers of SB-715992 effect in PBMCs.

NCT Registration ID (from clinicaltrials.gov): NCT00095992
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 24, 2004 Closing Date: May 04, 2006

Chair: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2399, (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2734


Permanently Closed
I171A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination with Standard Chemotherapy Regimens (CT) in Patients with Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumour Types Suitable for Treatment with Capecitabine


Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer or other tumour types with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; 14 days since major surgery; no prior therapy with angiogenesis inhibitor. For NSCLC: maximum of 1 prior single agent non-platinum chemotherapy for metastatic disease; no prior taxane therapy; no peripheral neuropathy > grade 1. For colorectal: suitable for first line therapy with capecitabine; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines. For other tumour types: suitable for treatment with capecitabine; patients with no more than 2 prior chemotherapy; LVEF >50% if prior anthracyclines/trastuzumab/cardiotoxic agents; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines.

Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colon cancer or other tumour types suitable for treatment with capecitabine and to determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. Also to assess the anti-tumour activity of AZD2171 in patients with measurable disease and to correlate patient outcomes (response) with baseline (tumour) and serial (urine and plasma) biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT00107250
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 13, 2005 Closing Date: February 17, 2009

Chair: (Canada) Dr. Derek Jonker, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70168, (Canada) Dr. Scott Laurie, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70173


Permanently Closed
I173A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic Cancer


Eligibility: Patients with unresectable, locally advanced or metastatic pancreatic cancer. No prior chemo therapy permitted except for 5FU(+/-folinic acid) or gemcitabine given concurrently with radiation.

Objectives: To determine the toxicity and RPII dose of AZD0530 when given in combination with Gemcitabine in patients with pancreatic cancer. To assess the efficacy of AZD0530 in combination with Gemcitabine in patients with pancreatic cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00265876
Participation: Participation is limited to invited centres only.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 19, 2005 Closing Date: May 29, 2008

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


Permanently Closed
I175A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer
The main purpose of this study is to find out what dose of an experimental drug called AZD2171 is safe to give to patients with advanced non-small cell lung cancer (NSCLC), when given in combination with a standard drugs called gemcitabine and cisplatin, and to find out what dose of this experimental drug called AZD2171 is safe to give to patients with advanced colorectal cancer when given in combination with a standard treatment called FOLFOX-6 (oxaliplatin, fluoruracil and leucovorin). As well, researchers will look at the side effects (good or bad) these drugs in combination cause when given all together. As well, researchers will look at blood levels fo find out how the drug combinations affect how the AZD2171 is distributed in the blood.

Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; at least 14 days since major surgery; no prior therapy with angiogenesis inhibitor. ECOG PS of 0,1 OR 2. No uncontrolled hypertension or CVD. No peripheral neuropathy > grade 1. Adequate bone marrow reserve and renal and liver function. For NSCLC: maximum of one prior single agent non-platinum chemotherapy for metastatic disease; no prior gemcitabine therapy. For colorectal: suitable for first line therapy with FOLFOX-6; no prior oxaliplatin patients with DPD deficiency or history of severe hand- foot syndrome from fluoropyrimidines are not eligible.

Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colorectal cancer. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. To assess the anti-tumour activity of AZD2171 in combination with standard chemotherapy regimens in patients with measurable disease.

NCT Registration ID (from clinicaltrials.gov): NCT00343408
Participation: Limited to invited centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 08, 2005 Closing Date: March 30, 2007

Chair: (Canada) Dr. Eric (Xueyu) Chen, University Health Network, (416) 946-2263, (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
I187A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer
The main purpose of this study is to find out what dose of an experimental drug called AZD2281 is safe to give to patients with advanced cancer in combination with another drug called Irinotecan without too many side-effects. Researchers will also look at blood levels to find out how the drug is distributed in the blood and will also investigate epithelial cells, previously removed tumour sample and new tumour biopsies (optional) to see what effects the drug will have on these samples.

Complexity Level: 1

Eligibility: Patients with histologically or cytologically documented colorectal cancer and must have locally advanced and/or metastatic colorectal cancer that is considered incurable and suitable for treatment with single agent irinotecan as a palliative intervention by the investigator. No anti-cancer treatment <= 21 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No GI tract disease resulting in an iability to adsorb oral medication.

Objectives: 1.1 To determine the recommended phase II dose of irinotecan given on day 1 by 90 minute infusion every 21 days with a biologically active dose of AZD2281 given orally bid continuously, in patients with locally advanced or metastatic incurable colorectal cancer. 1.2 To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of the combination of AZD2281 and irinotecan in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. 1.3 To assess preliminary evidence of the anti-tumour activity of AZD2281 in combination with irinotecan in patients with colorectal cancer with measurable disease. 1.4 To demonstrate the pharmacodynamic activity of AZD2281 in combination with irinotecan by establishing its effects in tumour biopsies, cheek swabs and blood samples. 1.5 To assess the correlation, if any, between patients with tumours demonstrating microsatellite instability and anti-tu

NCT Registration ID (from clinicaltrials.gov): NCT00535353
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 13, 2007 Closing Date: March 08, 2012

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


Permanently Closed
I1CNCIC CTG Phase II Study of Acivicin (AT125) in Colorectal Cancer


NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 03, 1981 Closing Date: May 31, 1982

Permanently Closed
I23NCIC CTG Phase II Study of Acivicin in Colon


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 17, 1985 Closing Date: April 28, 1986

Permanently Closed
I58NCIC CTG Phase II Study of DuP 937 in Patients With Colorectal Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 1991 Closing Date: November 10, 1991

Permanently Closed
I8NCIC CTG Phase II Study of N-methylformamide in Colon


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 14, 1984 Closing Date: April 29, 1985

Permanently Closed
I9NCIC CTG Phase II Study of TCAR in Colon


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 1985 Closing Date: March 05, 1986

Permanently Closed
I90NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 12, 1995 Closing Date: June 21, 1996

Chair: (Canada) Dr. Christine Cripps, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70176


Permanently Closed
I98NCIC CTG Phase I/II Study of Tomudex and Doxorubicin in Patients With Locally Advanced, Inoperable or Metastatic Gastric Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 24, 1996 Closing Date: April 07, 1999

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


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

Complexity Level: 2

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

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

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

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


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

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

Complexity Level: 2

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

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

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

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


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

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

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

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

Eligibility: Patients with advanced pancreatic cancer

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

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


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


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

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


Permanently Closed