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

Abstract 

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 1000mg/m² bid d1–14+oxaliplatin 130mg/m² d1, q3w) were followed by XELOX-RT (radiotherapy (50.4Gy), combined with capecitabine 750–675mg/m² bid every radiotherapy day and oxaliplatin 40–30mg/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 30mg/m² and 675mg/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 (30mg/m² oxaliplatin/675mg/m² capecitabine in combination with 50.4Gy/28 fractions) was well tolerated and effective for locally advanced pancreatic and biliary tract cancer.

Keywords: Biliary tract cancer, Capecitabine, Oxaliplatin, Pancreatic cancer, Radiotherapy