A Multicenter Prospective Randomized Controlled Trial of Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- 3-Year Disease-Free Survival
研究概览
简要总结
This multicenter, prospective, randomized clinical trial will enroll adults aged 18 to 75 years with resectable clinical stage I (T1-T2aN0M0) invasive non-small cell lung cancer presenting as a single solid nodule (consolidation-to-tumor ratio 1.0) in the left lung. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer and completion of standard lung resection and systematic mediastinal lymph node dissection, participants will be randomly assigned 1:1 either to undergo station 4L lymph node dissection or to omit station 4L dissection. The primary hypothesis is that omitting station 4L dissection is noninferior to performing it with respect to 3-year disease-free survival. Secondary outcomes include 3-year overall survival, perioperative complications, 90-day mortality, and station 4L nodal metastasis.
详细描述
Station 4L lymph nodes are located in a technically challenging area near the aortic arch, left pulmonary artery, thoracic duct, and left recurrent laryngeal nerve. Dissection may improve nodal staging but may also increase operative complexity and complications. This study will evaluate whether station 4L dissection can be omitted without compromising long-term outcomes in patients with early-stage left-sided invasive non-small cell lung cancer.
Eligible participants will undergo complete resection by segmentectomy or lobectomy and systematic mediastinal lymph node dissection. After intraoperative frozen-section confirmation of invasive non-small cell lung cancer, participants will be randomized in a 1:1 ratio to station 4L lymph node dissection or no station 4L dissection. Randomization is stratified by tumor lobe. The planned enrollment is 384 participants, including 258 with left upper lobe tumors and 126 with left lower lobe tumors.
Participants will be followed every 6 months for 3 years after surgery. The primary comparison is 3-year disease-free survival. Secondary assessments include 3-year overall survival, surgery-related complications within 30 days, all-cause mortality within 90 days, and the frequency of station 4L nodal metastasis among participants assigned to station 4L dissection.
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
- •Age 18 to 75 years.
- •A single solid pulmonary nodule (consolidation-to-tumor ratio of 1.0) located in the left lung.
- •Resectable clinical stage I (T1-T2aN0M0) non-small cell lung cancer, with a maximum tumor diameter of 4 cm or less, evaluated by positron emission tomography/computed tomography.
- •Planned complete lung resection by segmentectomy or lobectomy with systematic mediastinal lymph node dissection.
- •Intraoperative frozen-section pathological confirmation of invasive non-small cell lung cancer before randomization.
- •Able to provide written informed consent and willing to complete the protocol-specified follow-up.
排除标准
- •Intraoperative or postoperative pathology indicates noninvasive non-small cell lung cancer.
- •Surgical procedure other than segmentectomy or lobectomy.
- •Incomplete tumor resection or residual tumor.
- •History of another malignant tumor.
- •History of previous lung surgery.
- •Previous radiotherapy or chemotherapy for the current lung cancer.
研究组 & 干预措施
Station 4L Lymph Node Dissection
Participants undergo complete lung resection and systematic mediastinal lymph node dissection, including surgical dissection of station 4L lymph nodes.
干预措施: Station 4L Lymph Node Dissection (Procedure)
No Station 4L Lymph Node Dissection
Participants undergo complete lung resection and systematic mediastinal lymph node dissection, but station 4L lymph nodes are not surgically removed.
结局指标
主要结局
3-Year Disease-Free Survival
时间窗: From enrollment to 3 years
Proportion of participants alive without disease recurrence. A disease-free survival event is the first documented recurrence of non-small cell lung cancer or death from any cause.
次要结局
- 3-Year Overall Survival(From enrollment to 3 years)
- 30-Day Surgery-Related Complication Rate(From surgery through postoperative day 30)
- 90-Day All-Cause Mortality(From surgery through postoperative day 90)
- Station 4L Lymph Node Metastasis Rate(At postoperative pathological assessment, up to 30 days after surgery)
研究者
Haiquan Chen
director of thoracic surgery department
Fudan University