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Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer (CRTCOESC)
A three-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. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical. The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.
Details
| Lead sponsor | The First Affiliated Hospital of Henan University of Science and Technology |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 249 |
| Start date | 2014-10 |
| Completion | 2025-04-01 |
Conditions
- Stage III Esophageal Squamous Cell Carcinoma
- Stage II Esophageal Squamous Cell Carcinoma
Interventions
- Capecitabine(Aibin)
- Oxaliplatin(Aiheng)
- Radiotherapy
Primary outcomes
- Grade 3/5 acute toxicities — 90 days
Grade 3/5 acute toxicities occurred during or within 90 days after RT - OS-2 year — 2 years
Overall Survival rate in 2 year from Randomization
Countries
China