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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) National Surgical Adjuvant Breast and Bowel Project (NSABP) North Central Cancer Treatment Group National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303628 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: bevacizumab Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | 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 |
Estimated Enrollment: | 2100 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | May 2020 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.
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Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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Arm II: Experimental
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.
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Drug: bevacizumab
Given IV
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 vs 1), clinical staging (high risk [T3, N+, M0 or T4, any N, M0] vs low risk [T1-2, N+, M0 or T3, N0, M0]), prior pre-operative oxaliplatin (yes vs no), and prior radiotherapy dose (40-50 Gy vs > 50-55.8 Gy pre-operatively). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients who received prior neoadjuvant oxaliplatin including patients on protocol NSABP-R-04 receive up to 9 courses of treatment followed by leucovorin calcium IV and fluorouracil IV with (arm II) or without (arm I) bevacizumab for up to 3 courses.
Patients complete 10-15 minute questionnaires about bowel function 4 times during study treatment.
After completion of study treatment, patients are followed periodically for approximately 10 years.
PROJECTED ACCRUAL: A total of 2,100 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following clinical (e.g., before neoadjuvant therapy) or pathologic staging criteria:
T4, N0-2, M0 disease must meet 1 of the following criteria:
Must have undergone complete tumor resection ≥ 28 days ago and able to begin treatment by day 56
Must have undergone concurrent neoadjuvant chemoradiotherapy*
Must have undergone prior radiotherapy at a dose of 40-55.8 Gy** AND received 1 of the following chemotherapy regimens:
NOTE: **Intensity-modulated radiotherapy allowed
PATIENT CHARACTERISTICS:
INR ≤ 1.5
INR > 1.5 allowed provided patient is on full-dose anticoagulants AND meets all of the following criteria:
No other previous or concurrent malignancy except nonmelanoma skin cancer, breast cancer in situ, carcinoma in situ of the cervix, or previously treated nonpelvic cancer that has been disease-free for > 5 years
No nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study treatment including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No prior invasive procedure, including either of the following:
Study Chair: | Al B. Benson, MD, FACP | Robert H. Lurie Cancer Center |
Investigator: | Neal J. Meropol, MD | Fox Chase Cancer Center |
Study Chair: | Nicholas J. Petrelli, MD | Helen F. Graham Cancer Center at Christiana Hospital |
Study Chair: | Frank Sinicrope, MD | Mayo Clinic |
Study Chair: | J. D. Brierley, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000467561, ECOG-E5204, NSABP-ECOG-E5204, NCCTG-ECOG-E5204 |
Study First Received: | March 15, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00303628 |
Health Authority: | Unspecified |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Rectal neoplasm Calcium, Dietary Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients |