This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced 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 safty 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 104 cases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
77
Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.
Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.
Qianfoshan Hospital of Shandong
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Jining NO.1 People's Hospital
Objective response rate
Time frame: 3 months
Overall survival
Time frame: 36 months
Progression free survival
Time frame: 36 months
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