A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- survival rate
研究概览
简要总结
The purpose of this study is
- To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy.
- To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.
详细描述
According to different location of the primary lesion，the subject can be allocated to two sub-groups:
The patient with upper or middle thoracic esophageal cancer may be assigned to two field(T)-total mediastinal lymphadenectomy group,which is control group in this study or three field lymphadenectomy-Abdominal + mediastinal + cervical lymphadenectomy group,which is study group in this study randomly.
After the operation,the patient whose primary lesion is completely(R0) resected will be assigned to adjuvant chemotherapy group or interview group randomly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≤70 years old;
- •Karnofsky Performance Status（KPS）≥80;
- •Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially;
- •Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic.
- •The preoperative evaluation of organ function is tolerant of surgery and chemotherapy;
- •The subject can understand and sign the informed consent form (ICF);
- •The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin（HGB）≥9.0g/L; absolute neutrophils count（ANC）≥1.5×109/L; platelet count（PLT）≥100×109/L; total bilirubin（TBIL）≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)≤1.5N.
排除标准
- •Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer;
- •Advanced Esophageal Cancer;
- •Prior malignancy in 5 years recently;
- •History of previous chest radiotherapy;
- •History of cardio-cerebral vascular accident in 6 months lately;
- •The subject can not understand and sign the informed consent form(ICF).
研究组 & 干预措施
standard two field +follow-up
干预措施: standard two field Lymphadenectomy (Procedure)
standard two field +adjuvant chemotherapy
干预措施: adjuvant chemotherapy (Drug)
standard two field +adjuvant chemotherapy
干预措施: standard two field Lymphadenectomy (Procedure)
total two field+follow-up
干预措施: Total two field Lymphadenectomy (Procedure)
total two field+adjuvant chemotherapy
干预措施: adjuvant chemotherapy (Drug)
total two field+adjuvant chemotherapy
干预措施: Total two field Lymphadenectomy (Procedure)
three field+follow-up
干预措施: three field Lymphadenectomy (Procedure)
three field+adjuvant chemotherapy
干预措施: adjuvant chemotherapy (Drug)
three field+adjuvant chemotherapy
干预措施: three field Lymphadenectomy (Procedure)
结局指标
主要结局
survival rate
时间窗: 5 years
1. Disease-free survival 2. overall survival
次要结局
未报告次要终点
研究者
Peng Lin
Sun Yat-sen University Cancer Center
Sun Yat-sen University