Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer

N/ANot Yet RecruitingNCT07780591

Shanghai Chest Hospital100 enrolled

Overview

This is a single-center, prospective, single-arm, open-label clinical trial evaluating the efficacy and safety of septum-guided segmentectomy in patients with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer (NSCLC) with a consolidation-to-tumor ratio (CTR) greater than 0.5 and up to 1.0. All eligible participants will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status. The primary endpoint is 3-year recurrence-free survival (RFS).

Lobectomy has long been the standard surgical treatment for operable early-stage non-small cell lung cancer (NSCLC). Randomized studies such as Japan Clinical Oncology Group 0802/West Japan Oncology Group 4607L (JCOG0802/WJOG4607L) and Cancer and Leukemia Group B 140503 (CALGB 140503) have supported sublobar resection for selected early-stage peripheral NSCLC, but most evidence is concentrated in tumors measuring 2 cm or less. For patients with 2-3 cm, solid-predominant clinical stage IA3 peripheral NSCLC, prospective evidence on the oncologic safety and pulmonary function benefit of segmentectomy remains limited. septum-guided segmentectomy uses the intersegmental vein and intersegmental septal membrane as anatomical landmarks to standardize the intersegmental plane and achieve reproducible anatomical resection while preserving lung function. This study uses a single-arm objective performance criterion design. The planned enrollment is 100 participants, allowing for approximately 15% unevaluable or lost-to-follow-up participants, with a target evaluable sample of 83. Before proceeding with segmentectomy, intraoperative frozen-section biopsy of protocol-specified lymph node stations is required to confirm node-negative (N0) disease. A positive frozen-section result will lead to conversion to lobectomy plus systematic lymph node dissection as standard treatment, and the participant will be recorded as a screen failure for the primary efficacy analysis while contributing to safety follow-up as specified in the protocol. Participants will be followed after surgery at 1, 6, 12, 18, 24, 30, and 36 months, and annually during years 4 and 5. The primary endpoint is 3-year recurrence-free survival (RFS). Secondary and safety outcomes include pulmonary function changes, perioperative outcomes, microscopically margin-negative (R0) resection, lymph node assessment, local recurrence, overall survival, disease-free survival, quality of life, and postoperative adjuvant therapy.

Study Type

INTERVENTIONAL

Interventions

septum-guided anatomical segmentectomyPROCEDURE

septum-guided anatomical segmentectomy or combined segmentectomy performed for eligible peripheral clinical stage IA3 non-small cell lung cancer. The intersegmental vein and intersegmental septal membrane are used as anatomical landmarks to define the intersegmental plane. Intraoperative lymph node frozen-section biopsy must confirm node-negative (N0) status before segmentectomy proceeds; positive nodal disease leads to lobectomy plus systematic lymph node dissection as standard treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 80 years, male or female. * Clinical stage IA3 non-small cell lung cancer according to the International Association for the Study of Lung Cancer 9th edition tumor, node, metastasis classification; clinical T1cN0M0; tumor maximum diameter \>2 cm and \<=3 cm on imaging evaluation. * Consolidation-to-tumor ratio (CTR) \>0.5 and \<=1 on thin-section computed tomography. * Peripheral tumor judged by the investigator to be amenable to curative segmentectomy or lobectomy, with an anticipated ability to achieve the protocol-specified surgical margin. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Preoperative pulmonary function adequate for surgery, with forced expiratory volume in 1 second \>=60% predicted and single-breath diffusing capacity of the lung for carbon monoxide \>=60% predicted, unless otherwise documented after multidisciplinary evaluation. * Willing to undergo intraoperative lymph node frozen-section biopsy to confirm node-negative status and understands that a positive frozen-section result will lead to conversion to lobectomy as standard treatment and exclusion from the primary efficacy analysis. * Able to understand the study and voluntarily sign written informed consent. Exclusion Criteria: * Intraoperative lymph node frozen-section biopsy confirms N1 or N2 metastasis, or preoperative endobronchial ultrasound-guided biopsy or mediastinoscopy confirms N1, N2, or N3 metastasis, pleural dissemination, or distant metastasis. Patients with positive intraoperative frozen-section results will be converted to lobectomy plus systematic lymph node dissection as standard treatment and recorded as screen failures. * Multiple primary lung cancers or multiple pulmonary nodules requiring concurrent resection outside the protocol-defined scope that would affect assessment of the primary endpoint. * Prior ipsilateral lobectomy or segmentectomy, or severe pleural adhesions making the study procedure unevaluable. * Other active malignancy within 5 years, except cured low-risk tumors. * Severe cardiac, cerebral, hepatic, renal, or other disease that would preclude general anesthesia or curative lung cancer surgery. * Pregnant or breastfeeding women. * Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.

Outcomes

Primary Outcomes

3-Year Recurrence-Free Survival

Recurrence-free survival is defined as the time from surgery to the first imaging- or pathology-confirmed recurrence, metastasis, or death from any cause. The primary analysis will estimate the 3-year recurrence-free survival rate using the Kaplan-Meier method.

Time frame: Up to 3 years after surgery

Secondary Outcomes

Change in Forced Expiratory Volume in 1 Second at 6 Months

Change in forced expiratory volume in 1 second (FEV1) from preoperative baseline to 6 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.

Time frame: Baseline and 6 months after surgery

Change in Forced Expiratory Volume in 1 Second at 12 Months

Change in forced expiratory volume in 1 second (FEV1) from preoperative baseline to 12 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.

Time frame: Baseline and 12 months after surgery

Change in Forced Vital Capacity at 6 Months

Change in forced vital capacity (FVC) from preoperative baseline to 6 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.

Time frame: Baseline and 6 months after surgery

Change in Forced Vital Capacity at 12 Months

Change in forced vital capacity (FVC) from preoperative baseline to 12 months after surgery, reported as absolute and percent predicted values according to pulmonary function testing.

Time frame: Baseline and 12 months after surgery

Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 6 Months

Change in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) from preoperative baseline to 6 months after surgery.

Time frame: Baseline and 6 months after surgery

Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 12 Months

Change in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) from preoperative baseline to 12 months after surgery.

Time frame: Baseline and 12 months after surgery

Operative Time

Operative time measured in minutes from surgical incision to closure, or according to the start and end times recorded in the operative or anesthesia record.

Time frame: Intraoperative

Intraoperative Blood Loss

Estimated intraoperative blood loss measured in milliliters according to the operative or anesthesia record.

Time frame: Intraoperative

Chest Tube Duration

Duration of postoperative chest tube placement measured in days from surgery to chest tube removal.

Time frame: From surgery until chest tube removal, assessed up to 30 days

Postoperative Length of Stay

Length of postoperative hospital stay measured in days from surgery to discharge.

Time frame: From surgery until hospital discharge, assessed up to 30 days

Postoperative Complications

Incidence and severity of postoperative complications within 30 days after surgery, graded according to the Clavien-Dindo classification.

Time frame: Up to 30 days after surgery

Microscopically Margin-Negative Resection Rate

Proportion of participants with microscopically margin-negative resection based on the final pathology report.

Time frame: Day of final pathology report, up to 30 days after surgery

Lymph Node Assessment Quality

Quality of lymph node assessment, including the number and stations of sampled or dissected lymph nodes as documented in the operative and pathology records.

Time frame: Day of final pathology report, up to 30 days after surgery

Surgical Margin Distance

Distance from the tumor to the surgical resection margin, assessed from operative and final pathology findings.

Time frame: Perioperative period and day of final pathology report, up to 30 days after surgery

Local Recurrence Rate

Proportion of participants with local recurrence, including recurrence at the surgical margin, ipsilateral thoracic cavity, or hilar or mediastinal lymph nodes.

Time frame: Up to 5 years after surgery

Overall Survival

Overall survival is defined as the time from surgery to death from any cause.

Time frame: Up to 5 years after surgery

Disease-Free Survival

Disease-free survival is defined as the time from surgery to recurrence, metastasis, or death from any cause.

Time frame: Up to 5 years after surgery

Global Health Status and Quality of Life Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30

The global health status and quality of life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 will be reported as one score. The score ranges from 0 to 100; higher scores indicate better global health status and quality of life.

Time frame: Baseline, 6 months, 12 months, 36 months, and 60 months after surgery

Postoperative Adjuvant Therapy

Proportion of participants receiving postoperative adjuvant therapy and the type of adjuvant regimen administered during follow-up.

Time frame: Up to 5 years after surgery

Lung Cancer Symptom Burden Summary Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13

Lung cancer symptom burden will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13. A prespecified summary score will be calculated as the mean of the available questionnaire symptom item or scale scores after linear transformation to a 0 to 100 scale; higher scores indicate worse lung cancer symptom burden.

Time frame: Baseline, 6 months, 12 months, 36 months, and 60 months after surgery

Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes