A Phase III, Multicenter Randomized Controlled Study of Neo-adjuvant Chemotherapy Paclitaxel + Cisplatin Versus Surgery Alone for Stage IIA-IIIB Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 528
- 试验地点
- 9
- 主要终点
- Overall survival rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Signed informed consent document on file. 10.No metastatic lymph node in cervical by color doppler sonography.
排除标准
- •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.
研究组 & 干预措施
Neo-adjuvant chemotherapy group
Neo-adjuvant chemotherapy(cisplatin and paclitaxel):
- Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
- Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
- Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles.
Surgery:
2-3weeks after Neo-adjuvant chemotherapy
- Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.
- 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).
干预措施: cisplatin and paclitaxel (Drug)
结局指标
主要结局
Overall survival rate
时间窗: 5 years
次要结局
- Overall survival rate(1 years and 3 years)
- Disease free survival(5 years)
- assessment in perioperation-Removal rate (R0 resection rate)(perioperative period)
- assessment in perioperation-Rate of Operative Complication(perioperative period)
- assessment in perioperation-Mortality of perioperation(perioperative period)
- assessment in perioperation-Days of Hospitalization(perioperative period)
- assessment in perioperation-Thoracic Drainage(perioperative period)
- assessment in perioperation-Quantity of bleeding(perioperative period)
- assessment in perioperation-Time of operation(perioperative period)
- Quality of life(1 years)
- efficacy of neo-adjuvant chemotherapy--response rate(1-4 days before operation)
- toxicities of neo-adjuvant chemotherapy(from chemotherapy to perioperative period)
- prognostic factors(5 years)
- predictive factors(2 years)
研究者
Yin Li
Vice-President, Director of thoracic surgery department, Henan Cancer Hospital
Henan Cancer Hospital