A phase II trial of pre-operative capecitabine and concurrent radiation for locally advanced rectal cancer

3771 Background: Concurrent 5-FU-based chemotherapy and radiation therapy (RT) have an established role in the pre-operative management of locally advanced rectal cancer. Pathologic complete response (CR) rates have been reported from 10% to 50%. We sought to examine the efficacy and toxicity of capecitabine, an oral fluoropyrimidine prodrug, with concurrent RT for this disease. Methods: Between 1/02 and 12/03, 22 patients were enrolled and clinically staged by endorectal US, and CT or MRI. Patients with T3, T4, or lymph node (LN) positive adenocarcinoma of the rectum were eligible. RT was administered in 1.8 Gy fractions to a total dose of 50.4 Gy. Capecitabine (1650 mg/m2/d) was administered by mouth divided in two daily doses Monday through Friday during the entire course of radiation. Surgery was performed 6 to 8 weeks following completion of radiation. Four to 6 weeks after surgery an adjuvant course of capecitabine (2500 mg/m2/d) was administered for 14 days of a 3 week cycles for a total of 6 cycle...