NCT02461043Unknown3 期
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- 3 year relapse free survival
研究概览
简要总结
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.
- Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
- No standard postoperative adjuvant chemotherapy has ever been established.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to give informed consent
- •histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
- •node-positive and pathologic stage M0
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patients were enrolled 4 to 10 weeks after surgery
- •Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits
排除标准
- •prior chemotherapy or concurrent radiation therapy before esophagectomy
- •R1 or R2 resection
- •clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination
研究组 & 干预措施
Arm A
Experimental
chemotherapy and radiotherapy
干预措施: paclitaxel; cisplatin (Drug)
Arm A
Experimental
chemotherapy and radiotherapy
干预措施: radiation (Radiation)
Arm B
Active Comparator
radiotherapy
干预措施: radiation (Radiation)
结局指标
主要结局
3 year relapse free survival
时间窗: 5 years
次要结局
- 3 year overall survival(5 years)
研究者
Jie He
MD.,PhD
Chinese Academy of Medical Sciences
研究点 (1)
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