Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive NSCLC
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Xuhui
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Shanghai、Xuhui、中国、200000
- 招聘中
- Fudan University Shanghai Cancer Center
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接触：
- Yang Zhang, MD
- 电话号码：86-18717722753
- 邮箱：16301050173@fudan.edu.cn
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Station 4L Lymph Node Dissection
Participants undergo complete lung resection and systematic mediastinal lymph node dissection, including surgical dissection of station 4L lymph nodes.
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During complete lung resection and systematic mediastinal lymph node dissection, all lymphatic and fatty tissue in the station 4L region is surgically removed and submitted for pathological examination.
Other mediastinal stations are dissected according to the study protocol in both arms.
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无干预：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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3-Year Disease-Free Survival
大体时间：From enrollment to 3 years
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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.
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From enrollment to 3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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3-Year Overall Survival
大体时间：From enrollment to 3 years
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Proportion of participants alive 3 years after enrollment.
Death from any cause is counted as an event.
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From enrollment to 3 years
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30-Day Surgery-Related Complication Rate
大体时间：From surgery through postoperative day 30
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Proportion of participants with at least one surgery-related complication, graded according to Common Terminology Criteria for Adverse Events version 3.0.
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From surgery through postoperative day 30
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90-Day All-Cause Mortality
大体时间：From surgery through postoperative day 90
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Proportion of participants who die from any cause within 90 days after surgery.
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From surgery through postoperative day 90
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Station 4L Lymph Node Metastasis Rate
大体时间：At postoperative pathological assessment, up to 30 days after surgery
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Among participants assigned to station 4L lymph node dissection, the proportion with pathologically confirmed metastasis in resected station 4L lymph nodes.
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At postoperative pathological assessment, up to 30 days after surgery
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合作者和调查者
调查人员
- 首席研究员：Haiquan Chen、Fudan University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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