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Station 4L Lymph Node Dissection Versus No Dissection in Clinical Stage I Solid Nodule-Type Invasive NSCLC
Sponsor: Fudan University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
384
Start Date
2025-12-15
Completion Date
2030-12-15
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Xuhui, China