Non-Small Cell Lung Cancer
Conditions
Keywords
segmentectomy, clinical stage IA3, peripheral NSCLC
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREseptum-guided anatomical segmentectomy
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.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm objective performance criterion design. All eligible participants will receive septum-guided segmentectomy after confirmation of node-negative (N0) lymph node status by intraoperative frozen-section biopsy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-Year Recurrence-Free Survival | Up to 3 years after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second at 6 Months | Baseline and 6 months after surgery | 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. |
| Change in Forced Expiratory Volume in 1 Second at 12 Months | Baseline and 12 months after surgery | 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. |
| Change in Forced Vital Capacity at 6 Months | Baseline and 6 months after surgery | 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. |
| Change in Forced Vital Capacity at 12 Months | Baseline and 12 months after surgery | 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. |
| Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 6 Months | Baseline and 6 months after surgery | Change in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) from preoperative baseline to 6 months after surgery. |
| Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 12 Months | Baseline and 12 months after surgery | Change in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) from preoperative baseline to 12 months after surgery. |
| Operative Time | Intraoperative | 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. |
| Intraoperative Blood Loss | Intraoperative | Estimated intraoperative blood loss measured in milliliters according to the operative or anesthesia record. |
| Chest Tube Duration | From surgery until chest tube removal, assessed up to 30 days | Duration of postoperative chest tube placement measured in days from surgery to chest tube removal. |
| Postoperative Length of Stay | From surgery until hospital discharge, assessed up to 30 days | Length of postoperative hospital stay measured in days from surgery to discharge. |
| Postoperative Complications | Up to 30 days after surgery | Incidence and severity of postoperative complications within 30 days after surgery, graded according to the Clavien-Dindo classification. |
| Microscopically Margin-Negative Resection Rate | Day of final pathology report, up to 30 days after surgery | Proportion of participants with microscopically margin-negative resection based on the final pathology report. |
| Lymph Node Assessment Quality | Day of final pathology report, up to 30 days after surgery | Quality of lymph node assessment, including the number and stations of sampled or dissected lymph nodes as documented in the operative and pathology records. |
| Surgical Margin Distance | Perioperative period and day of final pathology report, up to 30 days after surgery | Distance from the tumor to the surgical resection margin, assessed from operative and final pathology findings. |
| Local Recurrence Rate | Up to 5 years after surgery | Proportion of participants with local recurrence, including recurrence at the surgical margin, ipsilateral thoracic cavity, or hilar or mediastinal lymph nodes. |
| Overall Survival | Up to 5 years after surgery | Overall survival is defined as the time from surgery to death from any cause. |
| Disease-Free Survival | Up to 5 years after surgery | Disease-free survival is defined as the time from surgery to recurrence, metastasis, or death from any cause. |
| Global Health Status and Quality of Life Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 | Baseline, 6 months, 12 months, 36 months, and 60 months after surgery | 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. |
| Postoperative Adjuvant Therapy | Up to 5 years after surgery | Proportion of participants receiving postoperative adjuvant therapy and the type of adjuvant regimen administered during follow-up. |
| Lung Cancer Symptom Burden Summary Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 | Baseline, 6 months, 12 months, 36 months, and 60 months after surgery | 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. |
Outcome results
None listed