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A phase Ⅲ multicenter trial of radiosensitizing effect and safety of sodium glycididazole in thoracic esophegeal squamous carcinoma
QIN Shang-bin*, WANG Ya-di, YANG Jun-quan, WANG Xiao-hu, LI Hai-bin, YANG Zhi-yong, YU Hong, LI Xue-ying, GAO Xian-shu
*Department Of Radiation Oncology, First Hospital, Peking University, Beijing 100034, China Corresponding author:GAO Xian-shu, Email:xsgao777@hotmail.com
Abstract Objective To evaluate the efficacy and clinical safety of sodium glycididazole (CMNa) in thoracic esophageal squamous carcinoma. Methods From June 1, 2008 to October 13, 2009, 66 pathologically 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 schedule:1.8－2.0 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 A:32;Group B:34), and four patients were unanalyzable, remaining 31 patients in each Group. Baseline factors were balanced. Results Follow-up rate was 97%. Group A vs. Group B:the overall response rate was 93.5% vs. 67.7%(χ2=6.61,P=0.01), 2-year overall survival was 39.9% vs.29.9%(χ2=0.62,P=0.433), 2-year cancer specific survival was 43.1% vs.26.8%(χ2=0.30,P=0.878), and 2-year progression-free survival was 30.1% vs. 27.9%(χ2=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.
QIN Shang-bin*,WANG Ya-di,YANG Jun-quan et al. A phase Ⅲ multicenter trial of radiosensitizing effect and safety of sodium glycididazole in thoracic esophegeal squamous carcinoma[J]. Chinese Journal of Radiation Oncology, 2012, 21(5): 426-428.
QIN Shang-bin*,WANG Ya-di,YANG Jun-quan et al. A phase Ⅲ multicenter trial of radiosensitizing effect and safety of sodium glycididazole in thoracic esophegeal squamous carcinoma[J]. Chinese Journal of Radiation Oncology, 2012, 21(5): 426-428.
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2012, Vol. 21 
