This study is a prospective, multicenter randomized controlled trial (RCT) designed to compare the efficacy of segmentectomy and lobectomy for invasive lung adenocarcinoma with a diameter of 2-3 cm and intraoperative frozen section-confirmed IASLC pathological new grade 1-2. The non-inferiority of segmentectomy is primarily evaluated by 5-year relapse-free survival (RFS) and overall survival (OS) after surgery, while secondary endpoints include pulmonary function preservation, perioperative complications, etc. With a planned enrollment of 587 patients over a 3-year recruitment period and a 5-year follow-up, this study aims to identify an optimized surgical approach.
Lung cancer is the most prevalent and lethal malignant tumor worldwide. Surgical resection remains the most effective treatment for early-stage lung cancer, with lobectomy historically serving as the standard procedure. Recent studies have demonstrated that segmentectomy can achieve comparable outcomes to lobectomy for tumors ≤2 cm and those with ground-glass opacity dominance (CTR ≤0.5). However, for invasive lung adenocarcinomas measuring 2-3 cm with solid predominance (CTR \>0.5), high-level evidence supporting segmentectomy as an alternative to lobectomy is lacking. The 2020 International Association for the Study of Lung Cancer (IASLC) proposed a new grading system for invasive adenocarcinoma, which stratifies prognosis based on histologic subtypes. Tumors with IASLC Grade 1-2 (≤20% high-grade components) have better outcomes, but their optimal surgical approach (segmentectomy vs. lobectomy) in solid-predominant lesions (2-3 cm) remains unproven. Intraoperative frozen section has shown high accuracy in diagnosing IASLC grades, enabling real-time surgical decision-making. The primary objective of this study is to evaluate whether segmentectomy is non-inferior to lobectomy in terms of 5-year relapse-free survival (RFS) and overall survival (OS) for patients with 2-3 cm lung adenocarcinomas confirmed as IASLC Grade 1-2 by intraoperative frozen section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
587
Segmentectomy is applied to lung adenocarcinomas with a diameter of 2-3 cm, in which intraoperative frozen pathology confirms a new pathological grade of 1-2.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of surgery to death from any cause. For surviving patients, survival time is censored at the last date when survival was confirmed; the study allows telephone confirmation of survival status, provided that medical records are available. For lost-to-follow-up patients, survival time is censored on the last date when survival was confirmed before the loss of follow-up. For patients diagnosed with non-malignant tumors, the date of surgery is used as the censorship point.
Time frame: 5 years
Recurrence-Free Survival (RFS)
Recurrence-Free Survi refers to the time from the date of surgery to the diagnosis of recurrence or death from any cause, whichever occurs first. "Recurrence" includes both cases confirmed by imaging diagnosis and clinical exacerbation (symptomatic aggravation) not confirmed by imaging diagnosis. For the former, the day of imaging examination is regarded as the recurrence date, while for the latter, the day of diagnosing symptomatic deterioration is considered the recurrence date. An increase in tumor marker values alone is not considered an RFS event. When recurrence is confirmed based on the pathological results of a biopsy specimen, if the patient had already been clinically diagnosed with recurrence before, the endpoint is the date of clinical diagnosis; otherwise, it is the biopsy date. The occurrence of other primary cancers is not considered an endpoint, and RFS continues until other events are identified.
Time frame: 5 years
Postoperative Respiratory Function
Patients underwent respiratory function tests (forced expiratory volume in 1 second) at 6 months and 12 months postoperatively to assess the differences between baseline respiratory function and that at 6 months and 12 months postoperatively.
Time frame: 12 months
Hospitalization Duration
The hospitalization duration was calculated as the median number of days from the date of surgery.
Time frame: 1 month
Chest Tube Placement Time
The chest tube placement time is calculated as the median number of days from the surgery date to chest tube removal. If the chest tube is placed after the patient's discharge, the placement time is calculated until the tube is removed. If the patient undergoes a second chest tube placement, the time after replacement is not included in the calculation.
Time frame: 1 month
Surgical Time
The surgical time is calculated as the duration from incision to the end of the operation.
Time frame: 1 day
Blood Loss
The blood loss is measured from the incision to the end of the operation and recorded in milliliters (mL).
Time frame: 1 day
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