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

Abstract

3504 Background: The aim of this trial was to investigate a potential survival benefit of concurrent chemotherapy (CT) in a neoadjuvant schedule. Methods: Eligibility criteria were : adenocarcinoma of rectum accessible to digital examination, resectable (R0, R1) T3–4 Nx M0, < 75 years, written informed consent. Patients were randomized between RT alone (45 Gy/25 fractions/5 weeks) and RT with concurrent CT using bolus 5FU 350 mg/m2 and FA 20 mg/m2 IV days 1–5 on weeks 1 and 5. Stratification on: sex, T3/T4, low/middle rectum. Surgery was performed after a delay of 3–10 weeks. All patients had to receive 4 cycles adjuvant FU-FA cycles. Primary endpoint was 5 year overall survival (OS) and the trial was designed to test an increase in OS from 52% to 62% with RT-CT. (type 1 error: 5% and type 2 error: 20%). Results: Between 1993/2003 out of 762 included patients, 733 were eligible. Patients characteristics were well-balanced between arms: median age 63 years, T3/T4: 89%/11%. Median time to surgery 5.3 weeks. The 4 adjuvant FU-FA cycles were given to 73% of pts in both arms. Main results are given in Table below. Median follow up time: 69.3 months. Conclusions: Preop RT-CT does not increase 5 year overall survival nor sphincter preservation. No significant financial relationships to disclose.