Preoperative (preop) radiotherapy (RT) + 5FU/folinic acid (FA) in T3,4 rectal cancers: Preliminary results of the FFCD 9203 randomized trial

3626 Background: In 1992 preop RT was considered in France as the standard treatment for T3,4 rectal cancer. The aim of this trial was to investigate a potential survival (S) benefit by using concurrent chemotherapy (CT). Methods: Eligibility criteria included: rectal adenocarcinoma accessible to digital rectal examination, resectable T3,T4NxM0, < 80 years, written informed consent. According to stratification criteria (sex/ T3-T4/ tumoral localisation), 762 patients (pts) were randomized between RT alone and CT/RT to demonstrate a 10% benefit in 5 year S (from 52% to 62%). RT involved 45 Gy in 25 fractions/5 weeks (wks) with Xray ≥ 8 MV. Concurrent CT consisted of bolus 5FU 350 mg/m2 and FA 20 mg/m2 IV days 1–5 (FUFA) on wks 1 and 5. Surgery was performed 3 -10 wks later. Then all pts had to receive 4 adjuvant FUFA cycles. Results: Preliminary analysis was performed on 685 eligible pts included between 4/1993 -11/2003. Pts' clinical characteristics were well-balanced between arms: median age 61 years, m/...