Neoadjuvant Chemotherapy Versus Surgery Alone for Esophageal Squamous Cell Carcinoma
- Registration Number
- NCT02395705
- Lead Sponsor
- Henan Cancer Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 528
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIA to IIIB, (7th Union for International Cancer Control, UICC-TNM).
- Patients must not have received any prior anticancer therapy of esophageal carcinoma.
- Age ranges from 18 to 75 years.
- Without operative contraindication.
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
- Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).
- expected R0 resection.
- ECOG 0～2.
- Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.
- Multiple primary cancer.
- The subject cannot understand and sign the informed consent form(ICF).
- Patients with concomitant hemorrhagic disease.
- Any un expected reason for patients can't get operation.
- Inability to use gastric conduit after esophagectomy because of a prior surgery.
- Pregnant or breast feeding.
- Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neo-adjuvant chemotherapy group cisplatin and paclitaxel Neo-adjuvant chemotherapy(cisplatin and paclitaxel): 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. Surgery: 2-3weeks after Neo-adjuvant chemotherapy 1. Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. 2. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
- Primary Outcome Measures
Name Time Method Overall survival rate 5 years
- Secondary Outcome Measures
Name Time Method assessment in perioperation-Thoracic Drainage perioperative period Thoracic Drainage days
Overall survival rate 1 years and 3 years Disease free survival 5 years assessment in perioperation-Removal rate (R0 resection rate) perioperative period The R0 resection rate of two groups
assessment in perioperation-Rate of Operative Complication perioperative period Complication rate after operation before discharge
assessment in perioperation-Mortality of perioperation perioperative period Mortality of perioperation 20 days before operation and 30 days after operation
assessment in perioperation-Days of Hospitalization perioperative period Days of Hospitalization after operation
assessment in perioperation-Quantity of bleeding perioperative period blood lose during operation
assessment in perioperation-Time of operation perioperative period the time from open thoracic cavity to the closure of the thoracic cavity
Quality of life 1 years ECOG, KPS, NRS-2002, EORTC QLQ-ST018, EORTC QLQ-C30
efficacy of neo-adjuvant chemotherapy--response rate 1-4 days before operation Criteria:Response Evaluation Criteria in Solid Tumors，RECIST. Pathologic Complete Response Rate. Pathologic Response Rate.
toxicities of neo-adjuvant chemotherapy from chemotherapy to perioperative period According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). The complete rate of protocol
prognostic factors 5 years prognostic factors for overall survival of both groups
predictive factors 2 years predictive factors for the efficiency of neo-adjuvant chemotherapy
Trial Locations
- Locations (9)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳FuZhou, Fujian, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Anyang cancer hospital
🇨🇳Anyang, Henan, China
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
🇨🇳ZhengZhou, Henan, China
Sun Yat-sen Uniersity Cancer Center
🇨🇳Guangzhou, Guangdong, China
Hunan Province Tumor Hospital
🇨🇳Changsha, Hunan, China
Fudan Universitay Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China