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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- 3-Year Recurrence-Free Survival
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: septum-guided anatomical segmentectomy (Procedure)
结局指标
主要结局
3-Year Recurrence-Free Survival
时间窗: 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.
次要结局
- 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 at 12 Months(Baseline and 12 months after surgery)
- Change in Forced Vital Capacity at 6 Months(Baseline and 6 months after surgery)
- Change in Forced Vital Capacity at 12 Months(Baseline and 12 months after surgery)
- 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 at 12 Months(Baseline and 12 months after surgery)
- Operative Time(Intraoperative)
- Intraoperative Blood Loss(Intraoperative)
- Chest Tube Duration(From surgery until chest tube removal, assessed up to 30 days)
- Postoperative Length of Stay(From surgery until hospital discharge, assessed up to 30 days)
- Postoperative Complications(Up to 30 days after surgery)
- Microscopically Margin-Negative Resection Rate(Day of final pathology report, up to 30 days after surgery)
- Lymph Node Assessment Quality(Day of final pathology report, up to 30 days after surgery)
- Surgical Margin Distance(Perioperative period and day of final pathology report, up to 30 days after surgery)
- Local Recurrence Rate(Up to 5 years after surgery)
- Overall Survival(Up to 5 years after surgery)
- Disease-Free Survival(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(Baseline, 6 months, 12 months, 36 months, and 60 months after surgery)
- Postoperative Adjuvant Therapy(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(Baseline, 6 months, 12 months, 36 months, and 60 months after surgery)
研究者
Junfeng Geng
Professor
Shanghai Chest Hospital