A phase Ⅲ multicenter trial of radiosensitizing effect and safety of sodium glycididazole in thoracic esophegeal squamous carcinoma / 中华放射肿瘤学杂志

ABSTRACT

ObjectiveTo evaluate the efficacy and clinical safety of sodium glycididazole (CMNa)in thoracic esophageal squamous carcinoma.Methods From June 1,2008 to October 13,2009,66pathologically proved thoracic esophageal squamous carcinoma (stage Ⅱa-Ⅲ,stage Ⅳ with metastases only in supraclavicular lymph nodes,by AJCC 6th ed) were randomized into radiotherapy plus CMNa (A) or radiotherapy plus placebo (B) group.Radiotherapy was given by conventional schedule1.8-2.0 Gy per fraction,5 times per week to a total dose of 66 Gy/6.6-7.2w.CMNa was given intravenously 800 mg/m2 3 times a week in solution of 100 ml saline within 30 minutes.Radiotherapy was started 30-60 minutes after completion of infusion.Patients of Group B received placebo in saline solution.A total of 66 patients were enrolled ( Group A32 ; Group B34 ),and four patients were unanalyzable,remaining 31 patients in each Group.Baseline factors were balanced.ResultsFollow-up rate was 97％.Group A vs.Group Bthe overall response rate was 93.5％ vs.67.7％ ( x2 =6.61,P =0.01 ),2-year overall survival was 39.9％ vs.29.9％ ( x2 =0.62,P =0.433 ),2-year cancer specific survival was 43.1％ vs.26.8％ ( x2 =0.30,P =0.878),and 2-year progression-free survival was 30.1％ vs.27.9％ ( x2 =0.02,P =0.586).No severe side effects observed.All patients tolerated CMNa infusion well.Conclusions CMNa is tolerable and effective as a hypoxic radiosensitizer,and its combination with radiotherapy can improve short term effect.However,survival is not improved within our follow-up period.