Microwave Ablation in Ground Glass Nodules
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- The survival of patients with GGO treated with MWA
研究概览
简要总结
GGO was commonly observed recently.Radiofrequency ablation has been widely applied in the treatment of patients with GGO. No study had explored the microwave ablation in the treatment of GGO.
详细描述
GGO was common with the development of image. Treatments of GGO include radical surgery and irradiation. For patients who were poor candidate of surgery, image guided thermal ablation could be an alternative.Radiofrequency ablation has been widely applied in the treatment of eary-stage non small cell lung cancer and those patients with GGO. However, up to date, no study had explored the microwave ablation in the treatment of GGO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All patient with GGO were treated with microwave ablation
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
- •Patient has a histologically verified AIS or MIA.
- •The tumors small enough to treat (usually ≤3 cm), and without chest pleura invasion.
- •Solid cements in the GGO less than 50%.
- •No other sites of disease observed.
- •Patient is not a candidate for surgical removal of the cancer, or refused surgery.
- •Patient is not a candidate for radiation therapy, or refused radiation therapy.
- •Patient has > 6 month life expectancy.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- •Sufficient organ functions.
- •Written informed consent.
排除标准
- •Active bacterial or fungous infection.
- •Simultaneous or metachronous (within the past 5 years) double cancers.
- •Women during pregnancy or breast-feeding.
- •Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.
- •Uncontrollable diabetes mellitus. History of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
研究组 & 干预措施
Microwave ablation in the GGO
Patients with GGO were treated with microwave ablation.
干预措施: Microwave ablaton (Other)
结局指标
主要结局
The survival of patients with GGO treated with MWA
时间窗: From the date of randomization until the date of the date of death from any cause, assessed up to 60 months
The overall survival
次要结局
- The disease free survival of patients with GGO treated with MWA(From date of randomization until the date of first documented progression, assessed up to 60 months)
研究者
Xin Ye
Principal Investigator
Shandong Provincial Hospital