Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 874
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?
详细描述
Patient Population:
Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.
R0 resection; T1-2, N+, M0.
Scheme:
After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (<3 or >=3). Then patients are randomized to 2 arms:
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
- •Age ≥ 18 and ≤70
- •ECOG performance status 0-1
- •Weight is not less than 90% of it before operation
- •Registration within 8 weeks after esophagectomy
- •Histologically proven primary thoracic esophageal squamous cell carcinoma
- •R0 resection and number of lymph nodes dissected ≥15 after esophagectomy
- •Stage T1-2N1-3M0 based pathological diagnosis
- •Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)
- •Without supraclavicular nodes and abdominal regions nodes existed after surgery
- •Without neo-adjuvant chemotherapy and radiotherapy
- •WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L
- •Platelets ≥ 100X109/L
- •Hemoglobin ≥ 90g/L(without blood transfusion)
- •AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal
- •Creatinine ≤ 1.5 x upper limit of normal
- •Sign study-specific informed consent prior to study entry
排除标准
- •Multiple primary esophageal tumors
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- •Severe, active comorbidity, defined as follows:
- •3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- •Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy
研究组 & 干预措施
B
After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)
干预措施: Elective nodal irradiation (ENI) (Radiation)
A
After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only
干预措施: Adjuvant chemotherapy only (Other)
结局指标
主要结局
Overall survival
To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0
次要结局
- Locoregional control rate
- Safety and Tolerability (incidence rate of adverse events)
- Failure pattern