Complete neoadjuvant therapy in rectal cancer (CONTRE): A Brown University Oncology Research Group phase II study.

Abstract

3530 Background: After preoperative chemoradiation and surgery, many patients (pts) with clinical stage II-III rectal cancer are unable to tolerate adjuvant FOLFOX chemotherapy, which may compromise disease-free and overall survival (DFS/OS). This study was designed to assess treatment delivery, toxicity and impact on pathologic response of administering chemotherapy prior to chemoradiation and surgery. Methods: Pts with clinical T3-4 and/or N1-2 rectal cancer, staged by endorectal ultrasound (ERUS) and pelvic MRI, received modified (m) FOLFOX6 every two weeks x eight cycles, followed by 50.4 Gy IMRT with concurrent capecitabine 825mg/m2 BID, 5 days per week, followed by surgery 4-8 weeks later. Results: There were 39 pts enrolled between August 2010 and June 2012; median age was 61 (30-79); clinical stage II n=7, stage III n=32. Distance from the anal verge: 5cm n=29. There were four pts presented with lumen obstruction preventing advancement of the endoscope and 31 with rectal blee...