Adjuvant Therapy for Patients with Colon Cancer
Name of the Trial
Phase III Randomized Study of Adjuvant Chemotherapy Comprising Fluorouracil, Leucovorin Calcium, and Oxaliplatin with versus without Bevacizumab in Patients with Resected Stage II or III Adenocarcinoma of the Colon (NSABP-C-08). See the protocol abstract at http://cancer.gov/clinicaltrials/NSABP-C-08.
Dr. Carmen Allegra, National Surgical Adjuvant Breast and Bowel Project
Why Is This Trial Important?
Colon cancer is the third most common cancer in men and women in the United States and accounts for 10 percent of all cancer deaths. Surgery is the standard treatment for colon cancer that has not spread (metastasized) to other areas of the body. Often, surgery is followed by treatment with chemotherapy to help kill any remaining cancer cells (called adjuvant chemotherapy).
Recent studies have shown that the effectiveness of chemotherapy for colon cancer that has metastasized can be improved with the addition of a monoclonal antibody called bevacizumab (Avastin). Bevacizumab blocks the action of a protein called vascular endothelial growth factor, which can help tumors establish a blood supply, so they can get oxygen and nutrients needed for growth.
With this study, researchers hope that patients undergoing adjuvant treatment for colon cancer that has not metastasized will also benefit from the addition of bevacizumab to chemotherapy.
"Bevacizumab inhibits the formation of blood vessels to tumors, thereby depriving the tumor of nutrients, and may increase the effectiveness of chemotherapy," said Dr. Allegra. "We hope that by adding bevacizumab to adjuvant chemotherapy, we will be able to prolong disease-free survival of people with colon cancer that can be surgically removed."
Who Can Join This Trial?
Researchers seek to enroll 2,632 patients aged 18 or over with a confirmed diagnosis of stage II or stage III colon cancer and who have had their tumors surgically removed. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NSABP-C-08.
Where Is This Trial Taking Place?
Multiple study sites in the United States and elsewhere are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/NSABP-C-08.
See the list of study contacts at http://cancer.gov/clinicaltrials/NSABP-C-08 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.