Final results of PETACC-6: Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine plus /- oxaliplatin in locally advanced rectal cancer

3500Background: The PETACC-6 trial investigated the role of oxaliplatin in combination with preoperative capecitabine-based chemoradiation (CRT) and postoperative capecitabine (CT) to improve disease-free survival (DFS) in locally advanced rectal cancer. Methods: Between 11/2008 and 09/2011, 1090 patients with rectal adenocarcinoma within 12 cm from the anal verge, T3/4 and/or node-positive, with no evidence of metastatic disease and considered either resectable at the time of entry or expected to become resectable, to 5 weeks preoperative CRT with capecitabine, followed by 6 cycles of adjuvant capecitabine without (arm 1) or with oxaliplatin (arm 2) (before and after surgery). The primary analysis was intent-to-treat and adjusted for stratification factors (clinical T category, nodal status, distance from the tumor to the anal verge and method of locoregional staging) except the center. Results: An early release of DFS after a medium follow-up of 31 months per recommendation of the IDMC, did not show any...