Alternate Title Phase III Randomized Study of Adjuvant Irinotecan, Fluorouracil, and Leucovorin Calcium Versus Oxaliplatin, Fluorouracil, and Leucovorin Calcium Versus Fluorouracil and Leucovorin Calcium in Patients With Stage II or III Rectal Cancer Receiving Combined Radiotherapy and Fluorouracil Either Preoperatively or Postoperatively
Special Category: CTSU trial Trial Description Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer. This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer. Eligibility criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Patients will be assigned to receive chemoradiotherapy either before or after surgery. Chemoradiotherapy before surgery and chemotherapy after surgery: Patients will receive one of three chemoradiotherapy regimens for up to 5.5 weeks. Within 3-8 weeks after completing chemoradiotherapy, they will undergo surgery to remove the tumor. Within 3-8 weeks after surgery, patients will be randomly assigned to one of three groups:
Chemoradiotherapy and chemotherapy after surgery: Patients will undergo surgery to remove the tumor. Within 8 weeks after surgery, patients will be randomly assigned to one of three groups:
Within 4 weeks after completing chemotherapy, patients will receive one of three chemoradiotherapy regimens for up to 5.5 weeks. Within 6 weeks after completing chemoradiotherapy, patients in groups one and two will receive up to four additional courses of chemotherapy and patients in group three will receive up to two additional courses of chemotherapy. All patients will be evaluated every 3 months for 3 years, every 6 months for 2 years, and once a year for 5 years. Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site. Trial Lead Organizations Eastern Cooperative Oncology Group
Related Information PDQ® clinical trial NSABP-R-04
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