Name of the Trial
Randomized Study of Preoperative Chemoradiotherapy Comprising Radiation Therapy and either Capecitabine or Fluorouracil with or without Oxaliplatin in Patients with Resectable Rectal Cancer (NSABP-R-04). See the protocol summary at http://cancer.gov/clinicaltrials/NSABP-R-04.

Principal Investigator
Dr. Robert Beart, National Surgical Adjuvant Breast and Bowel Project

Why This Trial Is Important
More than 40,000 new cases of rectal cancer are diagnosed each year in the United States. Surgery is the primary form of treatment for rectal cancer, but recurrence is common using surgery alone.

Presurgical treatment with chemotherapy and radiation therapy, known as neoadjuvant therapy, may help prevent cancer recurrence in the region around rectal tumors. Furthermore, neoadjuvant therapy has been shown to reduce the size of rectal tumors before surgery, and it may allow more patients to undergo sphincter-saving procedures. Preserving sphincter function without increasing the risk of local or regional recurrence is an important consideration in the treatment of rectal cancer.

To be eligible for this trial, patients must have rectal tumors that can be completely removed by surgery. They will be treated with chemotherapy and radiation therapy at the same time for 5 to 6 weeks before surgery. They will be divided into four groups based on the type of chemotherapy administered: intravenous (IV) 5-fluorouracil (5-FU) alone, IV 5-FU plus IV oxaliplatin, oral capecitabine alone, and oral capecitabine plus IV oxaliplatin.

"We hope to improve neoadjuvant therapy for rectal cancer with the use of oral capecitabine and addition of oxaliplatin and, through the collection of tissue samples, learn how to identify those patients who will benefit from neoadjuvant therapy," said Dr. Beart.

Who Can Join This Trial
Researchers seek to enroll 1,606 patients aged 18 and over with stage II or III rectal cancer that can be surgically removed. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/NSABP-R-04. This trial is eligible for special Medicare coverage: http://www.cancer.gov/clinicaltrials/developments/NCD179N.

Study Sites and Contact Information
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites and contacts at http://www.cancer.gov/clinicaltrials/NSABP-R-04 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.