Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 819
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.
详细描述
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.
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
- •Participants volunteer to participate the study and signed the informed consent.
- •Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
- •No antineoplastic treatments before operation.
- •According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
- •WHO PS score: 0-1;
- •Age and gender: 18-75 years old, male and female unlimited;
- •Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.
排除标准
- •The surgical approach is left thoracic approach;
- •Patients with severe postoperative complications who cannot receive adjuvant therapy;
- •Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer.
- •Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
- •Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency;
- •Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
- •Known or suspected allergy to chemotherapeutic drugs.
研究组 & 干预措施
Chemotherapy
Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.
干预措施: adjuvant treatment (Combination Product)
Chemoradiotherapy
5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
干预措施: adjuvant treatment (Combination Product)
Surgery alone
Surgery alone, no adjuvant treatment.
结局指标
主要结局
Overall Survival
时间窗: 5-year overall survival
overall survival rate of each arms
Overall Survival
时间窗: 3-year overall survival
overall survival rate of each arms
次要结局
- Adverse Events(1 year)
- Scores of Quality of Life(5 years)
- Disease Free Survival(5-year disease free survival)
- Disease Free Survival(3-year disease free survival)