Septum-guided Segmentectomy for 2-3 cm Clinical Stage IA3 Peripheral Non-Small Cell Lung Cancer (SGS2606)
2026年8月19日 更新者：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).
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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3-Year Recurrence-Free Survival
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second at 6 Months
時間枠：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
時間枠：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.
|
Baseline and 12 months after surgery
|
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Change in Forced Vital Capacity at 6 Months
時間枠：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
時間枠：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
時間枠：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.
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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
時間枠：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
時間枠：Intraoperative
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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
時間枠：Intraoperative
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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
時間枠：From surgery until chest tube removal, assessed up to 30 days
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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
時間枠：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
時間枠：Up to 30 days after surgery
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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
時間枠：Day of final pathology report, up to 30 days after surgery
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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
時間枠：Day of final pathology report, up to 30 days after surgery
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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
時間枠：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
時間枠：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
時間枠：Up to 5 years after surgery
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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
時間枠：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
時間枠：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.
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Baseline, 6 months, 12 months, 36 months, and 60 months after surgery
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Postoperative Adjuvant Therapy
時間枠：Up to 5 years after surgery
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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
時間枠：Baseline, 6 months, 12 months, 36 months, and 60 months after surgery
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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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2032年8月1日
研究の完了 (推定)
2034年8月1日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月19日
最初の投稿 (実際)
2026年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21日
QC基準を満たした最後の更新が送信されました
2026年8月19日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。