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Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive NSCLC

RecruitingNA

Sponsor: Fudan University

Conditions: Non-Small Cell Lung Cancer

Interventions: Station 4L Lymph Node Dissection

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Shanghai, Xuhui, China