A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a
(according to AJCC2002)
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging
(N0 or N1), then randomized to 2 arms at 1:1 ratio.
Arm Cisplatin:
Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.
Arm Paclitaxel:
Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant
chemotherapy for 2 cycles.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
1-yr overall survivals
1 year
No
Kuai Le Zhao, M.D.
Principal Investigator
Fudan University
China: Ethics Committee
ESO2012-01
NCT01591135
April 2012
April 2017
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