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Clinical Trials in China / NCT07801430
Recruiting Not applicable

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

NCT07801430 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Not applicable
Started
2025-12-15
Last updated
2026-09-09

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Station 4L Lymph Node Dissection

Station 4L Lymph Node Dissection: 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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Xuhui Recruiting

More Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07801430 on ClinicalTrials.gov ↗ ← All trials in China