A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to determined the best scheme in paclitaxel and cisplatin，paclitaxel and fluorouracil，paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel and Cisplatin (TP)
Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w*4
干预措施: Paclitaxel and Cisplatin (Drug)
Paclitaxel and Cisplatin (TP)
Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w*4
干预措施: Radiotherapy (Radiation)
Paclitaxel and Fluorouracil (TF)
Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w*2
干预措施: Paclitaxel and Fluorouracil (Drug)
Paclitaxel and Fluorouracil (TF)
Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w*2
干预措施: Radiotherapy (Radiation)
Paclitaxel and Carboplatin（TC）
Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w*2
干预措施: Paclitaxel and Carboplatin (Drug)
Paclitaxel and Carboplatin（TC）
Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w*2
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
overall survival
时间窗: 3 years
次要结局
- progression free survival(1year, 2 years, 3 years)
- adverse event(3 years)
研究者
Kuai Le Zhao, MD
Professor
Fudan University