NCT06646770尚未招募不适用
Segmentectomy Versus Lobectomy in Clinical T1c Non-Small Cell Lung Cancer: A Non-Inferiority Trial
Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年1月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Survival Survival
研究概览
简要总结
The goal of this clinical trial is to investigate the role of segmentectomy in clinical T1c (2-3 cm) non-small cell lung cancer (NSCLC). The main questions we aim to answer are:
- Is segmentectomy non-inferior to lobectomy in cT1c NSCLC in terms of overall and recurrence free survival?
- What are the mortality and morbidity rates of segmentectomy compared to lobectomy?
Researchers will compare segmentectomy and lobectomy in terms of overall and recurrence free survival.
Participants will:
- Undergo either pulmonary lobectomy or segmentectomy with mediastinal nodal dissection
- Be followed up with a chest CT in every 3 months in first year, every 6 months in second year and every year for following 3 years
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical T1c NSCLC
- •Parenchymal nodule >2 cm in diameter
- •Parenchymal nodule ≤3 cm in diameter
- •Consolidation / Tumor Rate (CTR) ≥ 0.50
- •Definitive pathological diagnosis of NSCLC preoperative or intraoperatively
- •No evidence of distant metastasis
- •No evidence of N2 disease
- •Adequate pulmonary functions for lobectomy or segmentectomy
排除标准
- •Pure GGO lesions
- •Pathologic diagnosis other than NSCLC
- •Technically not suitable for simple or complex segmentectomy, or lobectomy
- •Evidence of distant metastasis
- •Pathologically confirmed N2 or N3 disease
- •Major comorbidity that precludes surgery
- •Intraoperative mediastinal nodal dissection of less than 3 lymph node stations
- •Prior malignancy in five years
结局指标
主要结局
Survival Survival
时间窗: 5 years
Overall and recurrence free survival
次要结局
- Complication rate associated with surgery(90 days)
- Mortality rate(90 days)
研究者
Akif Turna
Professor
Istanbul University - Cerrahpasa (IUC)
研究点 (2)
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