Phase III trial comparing intensive induction chemoradiotherapy (60 Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000–01 FFCD/SFRO study

Abstract

BackgroundThe role of chemoradiation with systemic chemotherapy compared with chemotherapy alone in locally advanced pancreatic cancer (LAPC) is uncertain. Patients and methodsOne hundred and nineteen patients with LAPC, World Health Organization performance status of zero to two were randomly assigned to either the induction CHRT group (60 Gy, 2 Gy/fraction; concomitant 5-fluorouracil infusion, 300 mg/m2/day, days 1–5 for 6 weeks; cisplatin, 20 mg/m2/day, days 1–5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m2 weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m2 weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. ResultsOverall survival was shorter in the CHRT than in GEM arm [median survival 8.6 (99% confidence interval 7.1–11.4) and 13 months (8.7–18.1), P = 0.03]. One-year survival was, respectively, 32% and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3–4 toxic effects were recorded in the CHRT arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). ConclusionThis intensive induction schedule of CHRT was more toxic and less effective than gemcitabine alone.