Concurrent chemoradiotherapy of capecitabine with or without oxaliplatin versus cisplatin with fluorouracil for treatment of squamous oesophageal cancer in Chinese patients (CRTCOESC): an interim report of a randomised, open-label, multicentre trial

Abstract Background Chemoradiotherapy with fluorouracil and cisplatin (PF) has shown greater clinical efficacy for local advanced oesophageal cancer but with high rate of acute toxicities. We designed the CRTCOESC study to evaluate the effect and safety of capecitabine with or without oxaliplatin versus PF with chemoradiotherapy in Chinese patients with oesophageal cancer. Methods We this randomised, open-label, multicentre trial in nine cancer centres in Henan province, China, in Chinese patients with biopsy-proven squamous oesophageal cancer (T2-4N0-2M0). We randomly assigned patients (1:1:1) to receive single capecitabine, capecitabine plus oxaliplatin, or PF, and every patient received daily radiation of 50 Gy in 2 Gy dose per fraction. Patients were stratified by different regimens cycles. Both grade 3–5 acute toxicities and 2-year overall survival were the primary endpoint, with a planned accrual of 249 patients to detect a decrease in grade 3–5 acute toxicities from 40% to 20%. Interim analysis of acute toxicities and overall response was planned for the first 120 patients. This study is registered with ClinicalTrials, number NCT02025036. Findings Between October, 2014, and December, 2016, we accrued 128 patients, of whom 118 were eligible. 86 patients finished at least 16 weeks' follow-up and were included in the interim report (n=24 capecitabine group, n=37 capecitabine plus oxaliplatin group, and n=25 PF group). Pretreatment characters (age, gender, weight, performance status, clinical stage, lymphonodus status, and pathology grade) did not differ between the groups. Incidence of grade 3–5 acute toxicities was 25% in the capecitabine group, 32% in the capecitabine plus oxaliplatin group, and 64% in the PF group (p=0·03); the incidence was significantly lower in the capectitabine groups than the PF group (capectitabine vs PF p=0·041; capecitabine plus oxaliplatin vs PF p=0·022) and did not differ between capectitabine and capecitabine plus oxaliplatin (p=0·738). 56 patients had finished 1-year follow-up (n=12 capecitabine group, n=26 capecitabine plus oxaliplatin group, and n=18 PF group). The 1-year overall survival was 75% in the capecitabine group, 92% in the capecitabine plus oxaliplatin group, and 76% in the PF group (p=0·166). Nine patients died in total: three patients in the capecitabine group, two patients in the capecitabine plus oxaliplatin group, and four patients in the PF group. Interpretation Compared with PF, chemoradiotherapy with single capecitabine with or without oxaliplatin showed lower incidence of acute toxicities and similar 1-year overall survival. Funding National Natural Science Foundation of China.