A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- The overall survival
研究概览
简要总结
This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.
详细描述
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only
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
- •Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;
- •Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
- •The expectation of life is more than 6 months;
- •Age: 18~70 years old;
- •Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
- •ECOG (Eastern Cooperative Oncology Group) : 0-1;
- •Able to understand this study and have signed informed consent.
排除标准
- •Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;
- •Known or suspected of allergy to paclitaxel or carboplatin;
- •Female in pregnancy or lactating;
- •With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
- •Patients with peripheral neuropathy(CTC grade≥2);
- •With other malignant tumors before the recruitment.
- •The researchers consider that the patient is not appropriate to enroll the study;
- •The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.
研究组 & 干预措施
adjuvant chemoradiotherapy
Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
干预措施: Paclitaxel and carboplatin (Drug)
adjuvant chemoradiotherapy
Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
干预措施: Adjuvant radiotherapy (Radiation)
adjuvant radiotherapy
Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
干预措施: Adjuvant radiotherapy (Radiation)
结局指标
主要结局
The overall survival
时间窗: 3 years
To evaluate the 3 years overall survival of two groups.
次要结局
- Disease-free survival(3 years)
- Adverse Events(1 year)
- Scores of Quality of life(1 year)