Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
The purpose of this study is to compare early-stage peripheral non-small cell lung cancer lobectomy and sub-lobectomy surgery to evaluate if sub-lobectomy is as feasible and effective for the treatment of early-stage (diameter ≤2cm) peripheral non-small cell lung cancer as lobectomy.
详细描述
Objectives:To establish a database of patients with early lung cancer surgery,and evaluate if sub-lobectomy surgery is as feasible and effective as lobectomy surgery in patients with early-stage peripheral non-small cell lung cancer,by assessing the retainability of lung function.and improvement of quality of life in those patients.
Outline:This is a prospective, matched, controlled, open, multi-center clinical study. Select the early-stage peripheral NSCLC 630 patients (diameter≤2cm), according to age and lesion type (GGO component ratio) two matching factor of 1: 2 assigned to sub-lobectomy group and lobectomy group.Patients are followed up every 3 months for the first year and then every 6 months for the other 4 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed with stage I peripheral non-small cell lung cancer suitable for lobectomy.
- •aged 60 to 80 years old.
- •according to the Ministry of Health, "with primary lung cancer diagnostic and treatment practices" (2011 edition) completed preoperative clinical staging examination.
- •voluntary participation, signed informed consent.
排除标准
- •pathologic stage is N1, N2, or M1a.
- •received postoperative adjuvant therapy (chemotherapy or targeted therapy).
- •radiotherapy or chemotherapy before surgery.
- •small cell lung cancer
- •benign lesions
- •patient unwilling to cooperate with surgery or observation.
结局指标
主要结局
Disease-free survival
时间窗: participants will be followed from surgical treatment at least 5 years unless any evidence of disease progression or death
次要结局
- Overall survival(at least 5 years)
- Pulmonary function(Forced expiratory volume in one second, FEV1)
研究者
Xiuyi zhi
Chief Physician
Xuanwu Hospital, Beijing