Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer (SGS2606)
19 agosto 2026 aggiornato da: Junfeng Geng, Shanghai Chest Hospital
Efficacy and Safety of Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer: A Single-Center, Prospective, Single-Arm Clinical Trial
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).
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
100
Fase
- Non applicabile
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: septum-guided segmentectomy
Participants with 2-3 cm clinical stage IA3 peripheral non-small cell lung cancer and consolidation-to-tumor ratio (CTR) >0.5 to <=1.0 will undergo planned septum-guided anatomical segmentectomy or combined segmentectomy after intraoperative frozen-section confirmation of node-negative (N0) lymph node status.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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3-Year Recurrence-Free Survival
Lasso di tempo: 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.
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Up to 3 years after surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Forced Expiratory Volume in 1 Second at 6 Months
Lasso di tempo: 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.
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Baseline and 6 months after surgery
|
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Change in Forced Expiratory Volume in 1 Second at 12 Months
Lasso di tempo: Baseline and 12 months after surgery
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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.
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Baseline and 12 months after surgery
|
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Change in Forced Vital Capacity at 6 Months
Lasso di tempo: 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.
|
Baseline and 6 months after surgery
|
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Change in Forced Vital Capacity at 12 Months
Lasso di tempo: 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.
|
Baseline and 12 months after surgery
|
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Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 6 Months
Lasso di tempo: 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.
|
Baseline and 6 months after surgery
|
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Change in Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide at 12 Months
Lasso di tempo: 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.
|
Baseline and 12 months after surgery
|
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Operative Time
Lasso di tempo: 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.
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Intraoperative
|
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Intraoperative Blood Loss
Lasso di tempo: Intraoperative
|
Estimated intraoperative blood loss measured in milliliters according to the operative or anesthesia record.
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Intraoperative
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Chest Tube Duration
Lasso di tempo: 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.
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From surgery until chest tube removal, assessed up to 30 days
|
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Postoperative Length of Stay
Lasso di tempo: From surgery until hospital discharge, assessed up to 30 days
|
Length of postoperative hospital stay measured in days from surgery to discharge.
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From surgery until hospital discharge, assessed up to 30 days
|
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Postoperative Complications
Lasso di tempo: Up to 30 days after surgery
|
Incidence and severity of postoperative complications within 30 days after surgery, graded according to the Clavien-Dindo classification.
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Up to 30 days after surgery
|
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Microscopically Margin-Negative Resection Rate
Lasso di tempo: 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.
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Day of final pathology report, up to 30 days after surgery
|
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Lymph Node Assessment Quality
Lasso di tempo: 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.
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Day of final pathology report, up to 30 days after surgery
|
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Surgical Margin Distance
Lasso di tempo: Perioperative period and day of final pathology report, up to 30 days after surgery
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Distance from the tumor to the surgical resection margin, assessed from operative and final pathology findings.
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Perioperative period and day of final pathology report, up to 30 days after surgery
|
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Local Recurrence Rate
Lasso di tempo: Up to 5 years after surgery
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Proportion of participants with local recurrence, including recurrence at the surgical margin, ipsilateral thoracic cavity, or hilar or mediastinal lymph nodes.
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Up to 5 years after surgery
|
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Overall Survival
Lasso di tempo: Up to 5 years after surgery
|
Overall survival is defined as the time from surgery to death from any cause.
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Up to 5 years after surgery
|
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Disease-Free Survival
Lasso di tempo: Up to 5 years after surgery
|
Disease-free survival is defined as the time from surgery to recurrence, metastasis, or death from any cause.
|
Up to 5 years after surgery
|
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Global Health Status and Quality of Life Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Lasso di tempo: 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.
|
Baseline, 6 months, 12 months, 36 months, and 60 months after surgery
|
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Postoperative Adjuvant Therapy
Lasso di tempo: Up to 5 years after surgery
|
Proportion of participants receiving postoperative adjuvant therapy and the type of adjuvant regimen administered during follow-up.
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Up to 5 years after surgery
|
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Lung Cancer Symptom Burden Summary Score Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13
Lasso di tempo: 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.
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Baseline, 6 months, 12 months, 36 months, and 60 months after surgery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 agosto 2026
Completamento primario (Stimato)
1 agosto 2032
Completamento dello studio (Stimato)
1 agosto 2034
Date di iscrizione allo studio
Primo inviato
11 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
19 agosto 2026
Primo Inserito (Effettivo)
21 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
19 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SGS2606
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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