Document Classification

Section Type: METHODS

Text: In this multicentre, open-label, randomised, phase 3 study we randomly assigned patients with rectal adenocarcinoma, clinically staged as cT3-4 or any node-positive disease, to two groups : a control group receiving standard fluorouracil-based combined modality treatment, consisting of preoperative radiotherapy of 504 Gy in 28 fractions plus infusional fluorouracil (1000 mg/m (2) on days 1-5 and 29-33), followed by surgery and four cycles of bolus fluorouracil (500 mg/m (2) on days 1-5 and 29) ; or to an investigational group receiving preoperative radiotherapy of 504 Gy in 28 fractions plus infusional fluorouracil (250 mg/m (2) on days 1-14 and 22-35) and oxaliplatin (50 mg/m (2) on days 1, 8, 22, and 29), followed by surgery and eight cycles of oxaliplatin (100 mg/m (2) on days 1 and 15), leucovorin (400 mg/m (2) on days 1 and 15), and infusional fluorouracil (2400 mg/m (2) on days 1-2 and 15-16).