Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Ha… (NCT00217737) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
United States2,431 participantsStarted 2005-09-06
Plain-language summary
This randomized phase III trial studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. 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, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* STEP 1: INITIAL REGISTRATION
* The distal extent of the tumor must be \>= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be \>= 12 cm from the anal verge as determined by surgical examination; colonoscopy should be performed postoperatively for those unable to have a preoperative colonoscopy to guarantee there are no synchronous lesions
* 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
* High-risk patients will be randomized to treatment Arms A or B
* Low-risk patients will be registered to Arm C for observation
* NOTE: Every effort should be made to submit blocks (tumor and normal mucosa) to the Principal Coordinates Analysis (PCO) immediately; blocks CANNOT be accepted after day 50 (post surgery) in order to allow for molecular assessment
* Specific laboratory requirements for Step 2 must be obtained within 2 weeks prior to Step 2 randomization
* Patients must not have synchronous tumors
* Patients must not have appendiceal tumors
* Patients must not have a history of inflammatory bowel disease (IBD)
* Patients with hereditary non-polyposis colorectal cancer (HNPCC) are eligible
* Patients must have no history of isolated, distant, or non-contiguous intra-abdominal metastases, even if restricted
* Patients mus…
What they're measuring
1
Disease-free Survival Rate at 5 Years
Timeframe: Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization