Name of the Trial
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 (ECOG-E5204). See the protocol summary at http://cancer.gov/clinicaltrials/ECOG-E5204.

Principal Investigators
Drs. Al Benson and Neal Jay Meropol, ECOG; Dr. Nicholas Petrelli, NSABP; Dr. Frank Sinicrope, NCCTG; Dr. C. Gail Leichman, SWOG; and Dr. Joel Tepper, CALGB

Why This Trial Is Important
Surgery is the primary treatment for rectal cancer that has not spread (metastasized) to other parts of the body. Even though surgery can cure many patients with localized rectal tumors, recurrence after surgery remains a worrisome possibility.

To help prevent recurrence and improve survival, doctors are exploring the use of other treatments given either before (neoadjuvant) or after (adjuvant) surgery. In this trial, patients who were treated previously with neoadjuvant chemoradiotherapy (chemotherapy combined with radiation therapy) will be randomly assigned to receive adjuvant chemotherapy with or without the addition of the monoclonal antibody bevacizumab, which inhibits tumor blood vessel formation. Researchers will compare the overall survival of patients in the two treatment groups.

This trial is designed to accommodate patients who received neoadjuvant chemoradiotherapy as part of another clinical trial conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP-R-04 ¹).

"These two trials are intended to help define the best way to administer neoadjuvant and adjuvant treatment for rectal cancer," said Dr. Benson. "We hope to extend the benefits we have seen recently in adjuvant treatment for colon cancer to patients with rectal cancer."

Who Can Join This Trial
Researchers will enroll 2,100 patients aged 18 and over with surgically removed rectal cancer who received preoperative radiation and chemotherapy. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/ECOG-E5204. This trial is eligible for special Medicare coverage ².

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://www.cancer.gov/clinicaltrials/ECOG-E5204, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.