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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Sodium Glycididazole 800mg/m2.Three times a week (once every other one day),before radiation therapy, total 5-6 weeks.
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
Objective response rate
Time frame: up to 3 month
Overall survival
Time frame: 36 months
Progression free survival
Time frame: 36 months
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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