Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer

Background and purpose To investigate the efficacy and toxicity of a short intensive Uracil/Tegafur (UFT) based chemoradiotherapy scheme combined with celecoxib in locally advanced pancreatic cancer. Material and methods The Academic Medical Centre, Amsterdam and the Erasmus Medical Centre, Rotterdam enrolled 83 eligible patients with unresectable pancreatic cancer in a prospective multicentre phase II study. Median age was 62years, median tumour size 40mm and the majority of the patients (85%) had pancreatic head cancers. Treatment consisted of 20×2.5Gy radiotherapy combined with UFT 300mg/m2 per day, leucovorin (folinic acid) 30mg and celecoxib 800mg for 28days concomitant with radiotherapy. Four patients were lost to follow-up. Results Full treatment compliance was achieved in 55% of patients, 80% received at least 3weeks of treatment. No partial or complete response was observed. Median survival was 10.6months and median time to progression 6.9months. Toxicity was substantial with 28% grades III and IV gastro-intestinal toxicity and two early toxic deaths. Conclusions Based on the lack of response, the substantial toxicity of mainly gastro-intestinal origin and the reported mediocre overall and progression free survival, we cannot advise our short intensive chemoradiotherapy schedule combined with celecoxib as the standard treatment.