Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 634
- 试验地点
- 1
- 主要终点
- 5-year overall survival
研究概览
简要总结
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment. The main questions it aims to answer are:
The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer with CTR>0.5 located in the apical segment; The post-operative lymph node metastasis and recurrence-free survival. Participants will receive selective lymph node dissection as the surgical procedure.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who sign the informed consent form and are willing to complete the study according to the plan;
- •Aged from 18 to 80 years old;
- •ECOG equals 0 or 1;
- •Not receiving lung cancer surgery before;
- •Resectable peripheral cT1N0M0 tumors with CTR>0.5 located in the apical segment;
- •Non-lepidic predominant invasive NSCLC dignosed by frozen section;
- •Not receiving chemotherapy or radiotherapy before.
排除标准
- •Not cT1N0M0;
- •Nodules not located in the apical segment or CTR≤0.5;
- •Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung adenocarcinoma diagnosed cytologically or pathologically;
- •Receiving lung cancer surgery before;
- •Receiving radiotherapy or chemotherapy.
研究组 & 干预措施
Selective Lymph Node Dissection
Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment
干预措施: Selective Lymph Node Dissection (Procedure)
结局指标
主要结局
5-year overall survival
时间窗: 5 years
The event is defined as the death due to any causes.
次要结局
- 5-year recurrence-free survival(5 years)
- Lymph node metastasis(5 years)
- The accuracy of frozen section(5 years)
研究者
Haiquan Chen
Director in the Department of Thoracic Surgery, FUSCC
Fudan University