NCT04764227进行中（未招募）2 期
Phase II Study of Postoperative Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESO- Shanghai 17)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Local control rate
研究概览
简要总结
The purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Joined the study voluntarily and signed informed consent form;
- •Age 18-75;
- •ECOG 0-2;
- •Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
- •The operative incision healed well;
- •T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
- •No radiotherapy, chemotherapy or other treatments pre (post) surgery;
- •PS ECOG 0-2;
- •Life expectancy of more than 3 months;
- •Hemoglobin (Hb) ≥ 9 g/dL, WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L, Platelet count (Pt) ≥ 100 x 109/L;
- •Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL< 1.5 x ULN;
- •Renal function: creatinine < 1.5 x ULN
- •No immuno-deficiency;
- •Use of an effective contraceptive for adults to prevent pregnancy.
排除标准
- •Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
- •Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- •Participation in other interventional clinical trials within 30 days;
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
- •Drug addiction, Alcoholism or AIDS;
- •Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- •Unsuitable to be enrolled in the trial in the opinion of the investigators.
研究组 & 干预措施
Concurrent chemoradiotherapy group
Experimental
Interventions:
- Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5
- Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
干预措施: Paclitaxel (Drug)
Concurrent chemoradiotherapy group
Experimental
Interventions:
- Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5
- Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
干预措施: Carboplatin (Drug)
Concurrent chemoradiotherapy group
Experimental
Interventions:
- Chemotherapy: Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5
- Radiotherapy: A total dose of 50.4Gy will be delivered in 28 fractions at 1.8Gy/fraction, 5 fractions per week in 6 weeks. The CTV encompassed the bilateral supraclavicular, superior mediastinal, and subcarinal regions.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Local control rate
时间窗: 2 years
次要结局
- Overall survival(5 years)
研究者
研究点 (1)
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