Comparison of Segmentectomy and Lobectomy for Deeply Located, Solid-Dominant Early-Stage Non-Small Cell Lung Cancer (<=2 cm): A Multicenter, Open-Label, Randomized, Controlled, Non-Inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
SOLID is a multicenter, open-label, randomized, controlled, phase III non-inferiority trial comparing anatomic segmentectomy with lobectomy in patients with deeply located, solid-dominant, clinical stage IA non-small cell lung cancer (NSCLC) measuring <=2 cm. Eligible participants will undergo centralized imaging review and will be randomized preoperatively in a 1:1 ratio before induction of anesthesia.
The primary endpoint is 5-year overall survival. The key supportive secondary endpoint is 5-year recurrence-free survival. The study will enroll 1,200 participants and will use intention-to-treat analysis for the primary endpoint. An independent Data and Safety Monitoring Board and an independent Endpoint Adjudication Committee will oversee safety, surgical quality, data quality, and endpoint adjudication.
详细描述
Segmentectomy has been established as an accepted treatment option for selected small peripheral NSCLC, but high-level randomized evidence is limited for tumors located in the inner two-thirds of the lung parenchyma. Deep, solid-dominant nodules may have higher oncologic risk, more complex anatomy, and greater difficulty achieving conventional linear surgical margins.
This trial evaluates whether standardized anatomic segmentectomy, including surgical quality control and lymph-node dissection requirements, is non-inferior to lobectomy for overall survival in patients with deeply located, solid-dominant, clinical stage IA NSCLC <=2 cm. The trial incorporates centralized pre-randomization imaging review, mandatory recording of margin and surgical quality metrics, systematic or lobe-specific lymph-node dissection, independent endpoint adjudication, and DSMB safety and quality oversight.
Participants randomized to the segmentectomy arm will undergo anatomic segmentectomy when feasible. Conversion to lobectomy is required for intraoperative frozen-section N1/N2 nodal metastasis and may occur for inadequate margins, anatomic difficulty, or safety concerns. Participants randomized to the lobectomy arm will undergo standard anatomic lobectomy. Intraoperative findings and final pathology do not change the original randomized assignment for the primary intention-to-treat analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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.
- •Solitary pulmonary nodule with whole-tumor maximal diameter <=2 cm confirmed by preoperative thin-slice CT (<=1 mm) and 3D reconstruction.
- •Solid-dominant nodule with consolidation-to-tumor ratio (CTR) >0.5, including pure-solid nodules.
- •Deeply located lesion, defined as the lesion center located in the inner two-thirds of the lung field on axial, coronal, and sagittal MPR images.
- •Clinically definite suspected primary NSCLC after complete preoperative work-up and MDT discussion, with estimated malignancy probability >=95%. Preoperative pathologic confirmation is not mandatory, but preoperative or intraoperative pathology should be obtained when technically safe and feasible.
- •Complete staging with thin-slice contrast-enhanced chest CT, whole-body PET-CT, brain contrast-enhanced MRI or CT, and serum tumor markers as appropriate; clinical stage IA (cT1a-bN0M0) without regional nodal or distant metastasis.
- •Cardiopulmonary function sufficient to tolerate both lobectomy and segmentectomy, with FEV1 and DLCO >=60% predicted.
- •Written informed consent, including special disclosure that final pathology may be benign.
- •Centralized imaging review confirmation by the lead-center technical committee before randomization.
排除标准
- •Lesion located in the right middle lobe.
- •Lesion located in the inner two-thirds but adjacent to the lung apex or base and judged suitable for wedge resection.
- •Two or more lesions requiring anatomic resection. One secondary lesion requiring only non-anatomic wedge resection is allowed; two main lesions in the same segment are excluded.
- •Prior ipsilateral lung surgery or another malignancy within 5 years.
- •Severe cardiovascular or cerebrovascular disease or other comorbidity making lobectomy or conversion to lobectomy intolerable.
- •Planned basal segmentectomy (S7-10); proper segmentectomy is permitted.
研究组 & 干预措施
Segmentectomy
Participants assigned to this arm will undergo anatomic pulmonary segmentectomy. Combined segmentectomy or proper segmentectomy is permitted; basal segmentectomy (S7-10) is prohibited. Segmentectomy must include anatomic treatment of the segmental hilar artery, vein, and bronchus, margin assessment, and required lymph-node dissection. Conversion to lobectomy is permitted or required according to protocol-defined clinical and safety criteria.
干预措施: Anatomic Segmentectomy (Procedure)
Lobectomy
Participants assigned to this arm will undergo standard anatomic pulmonary lobectomy with required systematic or lobe-specific lymph-node dissection.
干预措施: Anatomic Lobectomy (Procedure)
结局指标
主要结局
Overall Survival
时间窗: 5 years after randomization
Overall survival is defined as the time from randomization to death from any cause. The primary analysis will compare segmentectomy with lobectomy using the intention-to-treat set and a non-inferiority hazard-ratio margin of 1.54.
次要结局
- Recurrence-Free Survival(5 years after randomization)
- Locoregional Recurrence Rate(Up to 5 years after randomization)
- Distant Metastasis Rate(Up to 5 years after randomization)
- Patient-Reported Quality of Life Score (EORTC QLQ-C30)(Baseline and 6, 12, and 36 months after surgery)
- Six-Minute Walk Distance(Baseline and 6 and 12 months after surgery)
- FEV1 Change Rate(Baseline and 6 and 12 months after surgery)
- Surgical Quality Metrics(Perioperative period)
- Perioperative Complications(Through discharge or 30 days after surgery, whichever came first)
- 30-Day Mortality(30 days after surgery)
- DLCO Change Rate(Baseline and 6 and 12 months after surgery)
- Patient-Reported Lung Cancer Symptom Score (EORTC QLQ-LC13)(Baseline and 3, 6, 12, and 36 months after surgery)
- 90-Day Mortality(90 days after surgery)
研究者
Zhigang Li
Professor
Shanghai Chest Hospital