Abstract
PURPOSE: To evaluate the efficacy and safety of the radiosensitizer-sodium glycididazole (CMNa) combined with definitive concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with locally advanced esophageal squamous cell carcinoma (ESCC). METHODS: Patients were enrolled and randomly assigned to receive CMNa plus CCRT (CMNa group) or CCRT alone (control group). CMNa (800 mg/m(2)) was administered three times per week during radiotherapy (1.8-2.0 Gy per fraction, total dose of 59.4-60.0 Gy). The primary endpoint was the objective response rate (ORR) and the secondary endpoint was the incidence of adverse events. RESULTS: Sixty-six patients with ESCC were recruited from six medical centers between 2016 and 2018. The ORRs in the CMNa and control groups were 90.32% and 68.57%, respectively (χ(2) = 4.925, p = 0.0265). The proportions of patients with a complete response were 8/31 (25.81%) and 8/35 (22.86%) in the CMNa and control groups, respectively. The combination of CMNa and CCRT did not increase the incidence of acute or late adverse effects. CONCLUSION: CMNa combined with CCRT improved the ORR in patients with ESCC compared with CCRT alone without increasing treatment-related toxicity. TRIAL REGISTRATION: The protocol was registered at Clinicaltrials.gov (www.clinicaltrials.gov) (Clinical Trials ID: NCT02721563). Study Registration Date: March 29, 2016.