DOI 10.1245/s10434-011-1933-7 ORIGINAL ARTICLE – COLORECTAL CANCER A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results

Abstract

Purpose. We designed American College of Surgeons Oncology Group (ACOSOG) Z6041, a prospective, multicenter, single-arm, phase II trial to assess the efficacy and safety of neoadjuvant chemoradiation (CRT) and local excision (LE) for T2N0 rectal cancer. Here, we report tumor response, CRT-related toxicity, and perioperative complications (PCs). Methods. Clinically staged T2N0 rectal cancer patients were treated with capecitabine and oxaliplatin during radiation followed by LE. Because of toxicity, capecitabine and radiation doses were reduced. LE was performed 6 weeks after CRT. Patients were evaluated for clinical and pathologic response. CRT-related complications and PCs were recorded. Results. Ninety patients were accrued; 6 received nonprotocol treatment. The remaining 84 were 65 % male; median age 63 years; 83 % Eastern Cooperative Oncology Group performance score 0; 92 % white; mean tumor size 2.9 cm; and average distance from anal verge 5.1 cm. Five patients were considered ineligible. Therapy was completed per protocol in 79 patients, but two patients did not undergo LE. Among 77 eligible patients who underwent LE, 34 patients achieved a pathologic complete response (44%) and 49 (64%) tumors were downstaged (ypT0–1)