The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent
radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive
chemoradiotherapy is the standard regimen in Western countries for patients with esophageal
cancer who can't receive surgery or reject surgery. But in China because of its severer toxic
reaction, most of patients had to discontinue treatment at the halfway way. Thus, the
chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to
its characristic of low toxic reaction.
The purpose of this study is to confirm the efficacy and safety of the different cycles(two
cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma
radical concurrent chemoradiotherapy. A total of 60 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.
Phase:
Phase 3
Details
Lead Sponsor:
The First Affiliated Hospital of Henan University of Science and Technology
Collaborators:
Anyang Tumor Hospital No. 150 Central Hospital of the Chinese People Liberation Army The First Affiliated Hospital of Zhengzhou University Xinyang Central Hospital