Stage III Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer
A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with
cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But
in China because of its toxic reaction, most of patients stop the halfway.
The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus
5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A
total of 210 patients will be accrued from China within 2 years. The primary endpoint is
overall survival and the secondary endpoints include progression-free survival, response
rate, pathologic complete response rate and adverse events.
We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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