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Brief Title: A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC
Official Title: A Perspective Trial of Sodium Glycididazole Combined With Concurrent Chemoradiotherapy for Locally Recurrent Squamous Cell Esophageal Carcinoma
Study ID: NCT02721576
Brief Summary: This is a perspective, multicenter,single arm, open study to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.
Detailed Description: The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safety of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%. The total sample size is 40 cases.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Qianfoshan Hospital of Shandong, Jinan, Shandong, China
Shandong Cancer Hospital and Institute, Jinan, Shandong, China
Jining NO.1 People's Hospital, Jining, Shandong, China
Liaocheng People Hospital, Liaocheng, Shandong, China
Qingdao Center Medical Group, Qingdao, Shandong, China
Rizhao City People 's Hospital, Rizhao, Shandong, China
Fei Cheng People's Hospital, Tai'an, Shandong, China
An Qiu People's Hospital, Weifang, Shandong, China
The Fourth People's Hospitalof Zibo, Zibo, Shandong, China
Name: Jinming Yu, Ph.D, M.D
Affiliation: Shandong Cancer Hospital and Institute
Role: PRINCIPAL_INVESTIGATOR