This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
366
Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe overall survival
To evaluate the 3 years overall survival of two groups.
Time frame: 3 years
Disease-free survival
To evaluate the 3 years disease-free survival of two groups.
Time frame: 3 years
Adverse Events
Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0
Time frame: 1 year
Scores of Quality of life
Assess the quality of life based on FACT-E
Time frame: 1 year
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