The effect of neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of neo-adjuvant therapy for esophageal carcinomas. One of our objectives is to evaluate whether the neo-adjuvant therapy with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients.
The effect of Neo-adjuvant chemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains the most controversial part of Neo-adjuvant therapy for esophageal carcinomas. Therefore, the optimal management of resectable esophageal squamous cell carcinomas differs widely among different areas based on local randomized controlled trials. The neo-adjuvant chemotherapy might be a good strategy if sufficient local control is achieved by surgical treatment. This study defined the detail of surgery procedure and the region of lymphadenectomy and adopted cisplatin and paclitaxel as neoadjuvant chemotherapy regimens. We try to evaluate the efficacy and safety of this neo-adjuvant strategy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
528
1. Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 2. Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles. 3. Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Overall survival rate
Time frame: 5 years
Overall survival rate
Time frame: 1 years and 3 years
Disease free survival
Time frame: 5 years
assessment in perioperation-Removal rate (R0 resection rate)
The R0 resection rate of two groups
Time frame: perioperative period
assessment in perioperation-Rate of Operative Complication
Complication rate after operation before discharge
Time frame: perioperative period
assessment in perioperation-Mortality of perioperation
Mortality of perioperation 20 days before operation and 30 days after operation
Time frame: perioperative period
assessment in perioperation-Days of Hospitalization
Days of Hospitalization after operation
Time frame: perioperative period
assessment in perioperation-Thoracic Drainage
Thoracic Drainage days
Time frame: perioperative period
assessment in perioperation-Quantity of bleeding
blood lose during operation
Time frame: perioperative period
assessment in perioperation-Time of operation
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Sun Yat-sen Uniersity Cancer Center
Guangzhou, Guangdong, China
Anyang cancer hospital
Anyang, Henan, China
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
Fudan Universitay Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
the time from open thoracic cavity to the closure of the thoracic cavity
Time frame: perioperative period
Quality of life
ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30
Time frame: 1 years
efficacy of neo-adjuvant chemotherapy--response rate
Criteria:Response Evaluation Criteria in Solid Tumors,RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.
Time frame: 1-4 days before operation
toxicities of neo-adjuvant chemotherapy
According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol
Time frame: from chemotherapy to perioperative period
prognostic factors
prognostic factors for overall survival of both groups
Time frame: 5 years
predictive factors
predictive factors for the efficiency of neo-adjuvant chemotherapy
Time frame: 2 years