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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 Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Bevacizumab in Patients Who Have Undergone Surgery and Neoadjuvant Chemoradiotherapy for Stage II or III Rectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI	ECOG-E5204 E5204, NSABP-ECOG-E5204, NCCTG-ECOG-E5204, NCT00303628

Special Category: NCI Web site featured trial, NCI - CMS pilot project trial

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery to completely remove the tumor within the past 4-8 weeks
• Received chemotherapy and radiation therapy before undergoing surgery
• No other previous chemotherapy or radiation therapy to the pelvis
• More than 4 weeks since surgery or open biopsy
• 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 randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive 2-hour infusions of oxaliplatin and 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 repeat every 2 weeks for up to 12 courses. Some patients may receive up to nine courses of treatment followed by infusions of leucovorin and fluorouracil with or without bevacizumab for up to three courses.

Patients in group two will receive a 30- to 90-minute infusion of bevacizumab, 2-hour infusions of oxaliplatin and 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 repeat every 2 weeks for up to 12 courses. Some patients may receive up to nine courses of treatment followed by infusions of leucovorin and fluorouracil with or without bevacizumab for up to three courses.

Patients will also complete questionnaires about bowel function four times during treatment.

After finishing treatment, patients will be evaluated periodically for approximately 10 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
Neal Meropol, MD, Protocol co-chair		Ph: 215-728-2450; 888-369-2427

National Surgical Adjuvant Breast and Bowel Project

Nicholas Petrelli, MD, Protocol chair		Ph: 302-623-4500 Email: npetrelli@christianacare.org

North Central Cancer Treatment Group

Frank Sinicrope, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

NCIC-Clinical Trials Group

J. D. Brierley, MD, Protocol chair		Ph: 416-946-2124 Email: james.brierly@rmp.uhn.on.ca

Related Information

PDQ® clinical trial NSABP-R-04
Featured trial article

Registry Information
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
Trial Start Date		2006-02-17
Trial Completion Date		2020-05-01 (estimated)
Registered in ClinicalTrials.gov		NCT00303628
Date Submitted to PDQ		2006-01-30
Information Last Verified		2009-04-30
NCI Grant/Contract Number		CA21115