A Multi-center, Prospective, Randomized Controlled Clinical Trial: Comparison Between Wedge Resection and Segmentectomy in the Surgical Treatment of Ground Glass Opacity-dominant Stage IA Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,382
- 试验地点
- 1
- 主要终点
- 5-year Progression-Free-Survival
研究概览
简要总结
The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC. However, one critical question needs to be addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al. reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive. Therefore, these lesions are potential candidates for wedge resection. This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.
详细描述
-
Selection procedures: When a case meets the inclusion criteria and does not meet exclusion criteria, the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the trial. The following rules will be strictly applied:
-
The application and confirmation of eligibility should be preoperatively completed and any postoperative application will not be accepted.
-
If the Eligibility Application Form is incomplete, it must be returned to be completed; otherwise, it will not be accepted.
-
After being approved by the Research Committee, the case will be assigned a number (Baseline Number, BN) and an Eligibility Confirmation Notice will be sent to the applicant.
-
After each research participating center receives the Eligibility Confirmation Notice, the research assistant of each center is responsible for the custody and documentation.
-
Once being selected for registration, the content of the Eligibility Application Form will be input into the database and the case's eligibility is not allowed to be cancelled, that is, the relevant information cannot be deleted from the database, unless the patient declines the information to be used in this study.
-
The data center will not accept any duplicated applications for any single case. If this happens, the first registered data will be used (i.e., the first time BN).
-
In cases of duplicated applications or registration errors, the research assistant of each research participating center shall contact the Research Committee as soon as possible for liaison and documentation.
-
Qualification of the responsible surgeons who participate in this study: the responsible surgeons who participate in this study shall meet the following qualifications: 1) at least have completed 20 cases of VATS segmentectomy; and 2) have passed the blind review of his/her video records of the surgery.
-
Criteria for confirming operation quality: for the case to be included in the analysis, the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures.
-
Rules for handling the excluded patients identified intraoperatively: if the responsible surgeon finds that the patient in operation meets the exclusion criteria, the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
5-year Progression-Free-Survival
时间窗: From date of the recruitment, assessed up to 60 months
次要结局
- 3-year Progression-Free-Survival(From date of the recruitment, assessed up to 36 months)
- Pulmonary function in the first year after surgery(From date of the 1 month\ 3 months\ 6 months\ 12 months after surgery in every recruited patient)
- 30-day Morbidity and mortality rates(From date of the recruitment, assessed up to 30 days)
- 5-year overall survival(From date of the recruitment, assessed up to 60 months)
- 10-year overall survival(From date of the recruitment, assessed up to 120 months)
研究者
Lunxu Liu
Professor and Chair of Department of Thoracic Surgery
West China Hospital