Adjuvant chemotherapy alone versus chemoradiation after curative resection for pancreatic cancer : feasibility results of a randomised EORTC/FFCD/GERCOR phase II/III study (40013/22012/0304)

4514 Background: The role of adjuvant therapy in resectable pancreatic cancer is debated. This randomised phase II intergroup study evaluated the feasibility and rate of completion for a modern gemcitabine-based chemoradiotherapy regimen after R0 resection of pancreatic head cancer. Methods: Patients were randomised within 8 weeks after surgery to receive either gemcitabine 1,000 mg/m2 weekly Q3 over 30 min then one week rest (control arm) or gemcitabine 1,000 mg/m2 for two cycles followed by weekly gemcitabine 300 mg/m2 with concurrent radiation of 50.4 Gy given in 28 fractions of 1.8 Gy (experimental arm). The primary endpoints of the phase II study were full completion of treatment and tolerability. Continuation of the trial into phase III with an overall survival primary endpoint was contingent on excluding a treatment completion rate ≤60% AND a rate of grade 4 haematological or GI toxicity ≥40% using a one step Bryant & Day phase II design. Results: Between September 2004 and January 2007, 90 patient...