This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5;repeated every 3 weeks)
preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week)
TianjinCIH
Tianjin, Tianjin Municipality, China
Overall Survival
Time frame: 3 years
Disease Free Survival
Time frame: 3years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
All participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 1 year
Objective Response Rate
Time frame: up to 24 weeks
Rate of R0 resection
Time frame: up to 24 weeks
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