This is a 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGScores of Quality of life
Assess the quality of life based on FACT-E.
Time frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Assess the safety and tolerability based on NCI CTC V4.0
Time frame: 1 year
Disease-free Survival
Three years disease free survival will be evaluated.
Time frame: 3 years
Overall Survival
Three years overall survival will be evaluated.
Time frame: 3 years
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