A Prospective, Randomised Phase 3 Study of High-dose Versus Standard-dose Radiation of Inoperable Esophageal Carcinoma Treated With Concurrent Chemoradiation
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Radiation therapy plus concurrent chemotherapy is now the standard therapy for patients with localized carcinoma of the esophagus selected for nonsurgical treatment. The standard radiation dose is 50-50.4Gy/1.8-2.0Gy/F.All of this were based on 2D radiation technology. Entering new century, 3D-CRT or IMRT has used on esophageal cancer. In China,the recommend radiation dose of concurrent chemoradiation was 60Gy. The study is a clinical phase III, randomized trial to compare the different radiation dose(60Gy vs 50Gy) of concurrent chemoradiation using 3D-CRT or IMRT in patients with unresectable esophageal 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytologic diagnosis of esophageal carcinoma
- •ECOG performance status 0-1
- •Age:18-70 years
- •Joined the study voluntarily and signed informed consent form
- •Patients must not have received any prior anticancer therapy
- •Unresectable disease, or refuse surgery.Stage Ⅰ-ⅣA（AJCC 2009）
- •Target lesions can be measured according to RECIST criteria
- •No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
- •Use of an effective contraceptive for adults to prevent pregnancy
- •Life expectancy of more than 3 months
排除标准
- •Multiple carcinomas of the esophagus,
- •Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
- •Metastatic disease (M1),
- •A primary tumor that extended to within 2 cm of the gastroesophageal junction,
- •Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
- •Concurrent pregnancy or lactation, history of a second malignancy other than nonmelanoma skin cancer
研究组 & 干预措施
high-dose
concurrent chemoradiation:CT:DDP 25mg/m2 D1+docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：60Gy/30F/6W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 75mg/m2 D1+docetaxel 75mg/m2 D1, Q3W
干预措施: intensity modulated radiation therapy in both arms (Radiation)
high-dose
concurrent chemoradiation:CT:DDP 25mg/m2 D1+docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：60Gy/30F/6W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 75mg/m2 D1+docetaxel 75mg/m2 D1, Q3W
干预措施: concurrent chemotherapy with radiation (Drug)
standard dose
concurrent chemoradiation:CT:DDP 25mg/m2 D1+Docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：50Gy/25F/5W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 5mg/m2 D1+Docetaxel75mg/m2 D1, Q3W
干预措施: intensity modulated radiation therapy in both arms (Radiation)
standard dose
concurrent chemoradiation:CT:DDP 25mg/m2 D1+Docetaxel 25mg/m2 D1,Weekly for 5 wks;RT：50Gy/25F/5W(3D-CRT or IMRT).Then,2 cycles consolidation chemotherapy were used:DDP 5mg/m2 D1+Docetaxel75mg/m2 D1, Q3W
干预措施: concurrent chemotherapy with radiation (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 5 years
次要结局
- Overall survival(5 years)