Comparison of Segmentectomy Versus Lobectomy for Early-stage Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field: A Prospective and Multi-center RCT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,120
- 试验地点
- 1
- 主要终点
- 5-year Disease-Free Survival
研究概览
简要总结
This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.
详细描述
Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P < 0.001) for non-small cell lung cancer ≤ 2 cm (CTR > 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18-75 years old;
- •6 mm ≤ tumor size ≤ 20 mm;
- •0.25 < CTR < 1;
- •Center of tumor located in the middle third of the lung field;
- •ECOG score of 0,1 or 2;
- •Lung function (FEV1 ≥ 1 L and ≥ 70%);
- •Both lung segmentectomy and lobectomy could achieve R0 resection;
- •No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
- •No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
- •Single tumor nodule or the concomitant nodule < microinvasive tumor;
- •Written informed consent.
排除标准
- •The tumor nodule is located in right middle lobe;
- •A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
- •Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
- •A serious mental illness;
- •Pregnant and lactating women;
- •Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
- •With the history of cerebral infarction or cerebral hemorrhage within 6 months;
- •With the history of sustained systemic corticosteroid therapy within 1 month;
- •The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
- •Other unsuitable situations;
结局指标
主要结局
5-year Disease-Free Survival
时间窗: From date of the recruitment, assessed up to 60 months
The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality
次要结局
- 30-day Morbidity and mortality rates(From date of the recruitment, assessed up to 30 days)
- 3-year Disease-Free-Survival(From date of the recruitment, assessed up to 36 months)
- 5-year overall Survival(From date of the recruitment, assessed up to 60 months)
- Pulmonary function in the first year after surgery(From date of the 3rd, 6th, and 12th month after surgery)