Multicentre phase I–II trial of capecitabine and oxaliplatin in combination with radiotherapy for unresectable pancreatic and biliary tract cancer: The CORGI-U study

Background and Purpose In this multicentre phase I–II trial we evaluated the feasibility and efficacy of capecitabine and oxaliplatin followed by the combination of these two drugs with radiotherapy in patients with locally advanced pancreatic or biliary tract cancer. Material and methods Thirty-nine patients with inextirpable adenocarcinoma of the pancreas, gallbladder or extrahepatic bile ducts were included. Two cycles of XELOX (capecitabine 1000 mg/m2 bid d1–14 + oxaliplatin 130 mg/m2 d1, q3w) were followed by XELOX-RT (radiotherapy (50.4 Gy), combined with capecitabine 750–675 mg/m2 bid every radiotherapy day and oxaliplatin 40–30 mg/m2 once weekly). Primary end-points were tolerance (phase I) and objective response (phase II). Results The maximum tolerated doses of oxaliplatin and capecitabine to combine with irradiation were 30 mg/m2 and 675 mg/m2, respectively. Twenty-one percent (95% CI: 9–38%) of evaluable patients achieved partial response. Five patients went through surgery (three R0 resections). Two-year survival was 28%, and estimated local tumour control rate at 2 years was 72%. The most common grade 3–4 toxicity was nausea and vomiting. Conclusions XELOX-RT (30 mg/m2 oxaliplatin/675 mg/m2 capecitabine in combination with 50.4 Gy/28 fractions) was well tolerated and effective for locally advanced pancreatic and biliary tract cancer.