3521Background: STAR-01 is a randomized phase III trial investigating the effect of adding oxaliplatin (OXA) to preoperative (preop) 5-fluorouracil (FU)-based pelvic chemoradiation (CRT) in patients (pts) with resectable locally advanced rectal cancer (LARC). No benefit from adding OXA could be demonstrated on primary tumor response to preoperative chemoradiation (Aschele, J Clin Oncol, 2011). Methods: Eligibility required a resectable, biopsy-proven rectal adenocarcinoma within 12 cm from the anal verge with radiological evidence of perirectal fat or nodal involvement. Randomization was between infused FU (225 mg/msq/day) concomitant to external-beam pelvic radiation (50.4 Gy in 28 daily fractions) (arm A) or the same regimen + weekly OXA (60 mg/msq x 6) (Arm B). Overall survival (OS) was the primary endpoint (252 deaths required to have a log-rank test with 80% power to detect a 30% reduction in mortality rates at the 5% two-sided significance level). Results: From November 2003 through August 2008, 739...