Two Cycles Versus Four Cycles of Capecitabine Combined Oxaliplatin Concurrent Radiotherapy as First-line Therapy for Chinese Locally Advanced Esophageal Squamous Cell Carcinomas, an Open Randomised Phase III Cilinical Trial (DCOECRT)

NCT02604615 Phase 3 UNKNOWN

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.

Details

Lead sponsor	The First Affiliated Hospital of Henan University of Science and Technology
Phase	Phase 3
Status	UNKNOWN
Enrolment	60
Start date	2014-10
Completion	2020-12

Conditions

• Stage III Esophageal Squamous Cell Carcinoma
• Esophageal Neoplasms

Interventions

• Capecitabine(Aibin)
• Oxaliplatin(Aiheng)
• Radiotherapy

Primary outcomes

• overall survival, OS — 2 years

Countries

China