Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer
Patient Population:
Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1,
M0
Scheme:
Patients are randomized to 2 arms:
Arm A:
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery,
consolidate paclitaxel/carboplatin 2 cycles.
Arm B:
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f),
consolidate paclitaxel/carboplatin 2 cycles.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Scores of Quality of life
Assess the quality of life based on FACT-E.
1 year
No
Weimin Mao, MD
Principal Investigator
Zhejiang Cancer Hospital
China: Food and Drug Administration
ZhejiangCH09
NCT01463501
October 2011
December 2016
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