Comparison of Video-assisted Thoracoscopic Segmentectomy Versus Lobectomy for Lung Adenocarcinoma in Situ and With Microinvasion
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Relapse-free survival
研究概览
简要总结
This is a Prospective, open-label, parallel, multi-center, Phase III randomized trial to evaluate the efficacy and safety of video-assisted thoracoscopic segmentectomy versus Lobectomy in treating patients with Lung adenocarcinoma in situ or with microinvasion.
详细描述
Lobectomy has long been considered the standard procedure for early-stage lung cancer, and minimally invasive techniques have been demonstrated to be associated with superior outcomes compared with lobectomy by thoracotomy. the us of segmentectomy is under investigation for selected patients with small tumors, and the use of minimally invasive strategies is applicable as well.
This nationwide, multicenter, prospective, randomized open phase III study of cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy versus Lobectomy for stage IA non-small cell lung cancer (NSCLC) patients with Lung adenocarcinoma in situ or with microinvasion, is aiming to evaluate the relapse free survival and 5 year overall survival (OS) rate of two types of surgery. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo cVATS lobectomy.
- Arm II: Patients undergo cVATS segmentectomy.
Patients will be followed up every 3 months within the first year, and annually for 5 years postoperatively.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative criteria: peripheral non-small cell lung cancer, no larger than 2 cm in maximal diameter, no lymph node metastasis, FEV1%>50% (FEV1: Forced Expiratory Volume in 1 second);
- •Preoperative imaging:pure ground-glass or mixed ground-glass nodules (part-solid, solid areas < 0.5cm);
- •Follow-up duration last 3 months or more, HRCT (HRCT: high-resolution computed tomography) lesion maximum diameter was measured three times and took the average, meet the criteria of clinical surgical indications;
- •Intraoperative criteria: histologically confirmed NSCLC, adenocarcinoma in situ or with microinvasion;
- •No prior ipsilateral thoracotomy;
- •No prior anti-neoplastic therapy;
- •EOCG Performance status 0-2;
- •Sufficient organ functions;
- •Written informed consent.
排除标准
- •Active bacterial or fungous infection;
- •Simultaneous or prior (within the past 5 years) other malignant disease;
- •Interstitial pneumonitis, pulmonary fibrosis, or severe COPD (COPD: chronic obstructive pulmonary disease);
- •Abnormal Psychosis;
- •Uncontrollable diabetes mellitus;
- •History of severe cardiovascular disease;
- •Any condition which, in the opinion of the investigator might interfere with the evaluation of the objective.
研究组 & 干预措施
segmentectomy
Patients undergo cVATS (complete Video-assisted Thoracoscopic Surgery) segmentectomy
干预措施: patients undergo cVATS segmentectomy (Procedure)
Lobectomy
Patients undergo cVATS lobectomy
干预措施: Patients undergo cVATS lobectomy (Procedure)
结局指标
主要结局
Relapse-free survival
时间窗: From date of randomization until the date of first documented relapse or metastasis, whichever came first, assessed up to 5 years
Compare the relapse-free survival (RFS) of patients with lung adenocarcinoma in situ or microinvasion undergoing cVATS segmentectomy vs lobectomy.
次要结局
- postoperative complication(0 to 3 months postoperatively)
- pulmonary function(6 months after surgery)
- Quality of Life(0 to 6 months postoperative)
- 5-year survival rate(participants are followed until death or up to 5 years)
研究者
Jianxing He
President
The First Affiliated Hospital of Guangzhou Medical University