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NSABP Clinical Trials Overview

Protocol R-03
A Clinical Trial to Evaluate the Worth of Preoperative Multimodality Therapy (5FU+LV+RTX) in Patients with Operable Carcinoma of the Rectum

Specific Aims
The primary purpose of this study is to determine whether the administration of preoperative chemotherapy (5FU+LV) and radiotherapy, followed by postoperative chemotherapy, is more effective than the administration of postoperative chemotherapy and radiotherapy in improving the disease-free survival and survival of patients with operable carcinoma of the rectum. Secondary aims of the study include the assessment of the effect of preoperative therapy on tumor response, tumor downstaging, rate of local recurrence, and type of operation (sphincter-saving procedures versus abdominoperineal resections).