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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
384
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.
Fudan University Shanghai Cancer Center
Shanghai, Xuhui, China
RECRUITING3-Year Disease-Free Survival
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.
Time frame: From enrollment to 3 years
3-Year Overall Survival
Proportion of participants alive 3 years after enrollment. Death from any cause is counted as an event.
Time frame: From enrollment to 3 years
30-Day Surgery-Related Complication Rate
Proportion of participants with at least one surgery-related complication, graded according to Common Terminology Criteria for Adverse Events version 3.0.
Time frame: From surgery through postoperative day 30
90-Day All-Cause Mortality
Proportion of participants who die from any cause within 90 days after surgery.
Time frame: From surgery through postoperative day 90
Station 4L Lymph Node Metastasis Rate
Among participants assigned to station 4L lymph node dissection, the proportion with pathologically confirmed metastasis in resected station 4L lymph nodes.
Time frame: At postoperative pathological assessment, up to 30 days after surgery
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