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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 and over NCI ECOG-E3201 E3201, NCT00068692

Special Category: CTSU trial

Trial Description

Purpose:

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:

Eligibility criteria include the following:

• At least 18 years old
• No distant metastases
• No previous chemotherapy
• No previous radiation therapy to the pelvis
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

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:

• Group one: Patients will receive a 1.5-hour infusion of irinotecan and a 2-hour infusion of leucovorin on day 1. They will also receive a 2-day continuous infusion of fluorouracil beginning on day 1. Treatment may be repeated every 2 weeks for up to eight courses.



• Group two: Patients will receive a 2-hour infusion of oxaliplatin and a 2-hour infusion of leucovorin on day 1. They will also receive a 2-day continuous infusion of fluorouracil beginning on day 1. Treatment may be repeated every 2 weeks for up to eight courses.



• Group three: Patients will receive a 2-hour infusion of leucovorin and a 1-hour infusion of fluorouracil once a week for 6 weeks. Treatment may be repeated every 8 weeks for up to three courses.

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:

• Group one: Patients will receive a 1.5-hour infusion of irinotecan, a 2-hour infusion of leucovorin, and an infusion of fluorouracil on day 1. They will also receive a 2-day continuous infusion of fluorouracil beginning on day 1. Treatment may be repeated every 2 weeks for up to four courses.



• Group two: Patients will receive a 2-hour infusion of oxaliplatin, a 2-hour infusion of leucovorin, and an infusion of fluorouracil on day 1. They will also receive a 2-day continuous infusion of fluorouracil beginning on day 1. Treatment may be repeated every 2 weeks for up to four courses.



• Group three: Patients will receive a 2-hour infusion of leucovorin and a 1-hour infusion of fluorouracil once a week for 6 weeks. Patients will receive one course of treatment.

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 Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Al Benson, MD, FACP, Protocol chair		Ph: 312-695-6180
Bruce Giantonio, MD, Protocol co-chair(Contact information may not be current)		Ph: 215-662-8624
Neal Meropol, MD, Protocol co-chair		Ph: 215-728-2450; 888-369-2427

Related Information

PDQ® clinical trial NSABP-R-04

Registry Information
Official Title		Intergroup Randomized Phase III Study Of Postoperative Irinotecan, 5-Fluorouracil And Leucovorin Vs Oxaliplatin, 5-Flourouracil And Leucovorin Vs 5-Fluorouracil And Leucovorin For Patients With Stage II or III Rectal Cancer Receiving Either Preoperative Radiation And 5-Fluorouracil Or Postoperative Radiation And 5-Flourouracil
Trial Start Date		2003-10-15
Registered in ClinicalTrials.gov		NCT00068692
Date Submitted to PDQ		2003-08-04
Information Last Verified		2005-11-01
NCI Grant/Contract Number		CA21115

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