Microwave Ablation in the Treatment of Stage I Non Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
Lung cancer, the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery, and some patients were unfit for surgery due to the poor cardio-pulmonary function or refuse surgery. For those patients, microwave ablation (MWA) could be an alternative treatment. Several small sample retrospective studies verified that MWA could be an efficacy and safe treatment.
详细描述
Patients with stage I non small cell lung cancer unfit for or refused surgery will be treated with MWA in the primary tumor sites.
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
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 or cytologically verified NSCLC,
- •The tumors small enough to treat (usually <4 cm), and without chest pleura invasion.
- •Clinical stage I NSCLC with no other sites of disease,.
- •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.
结局指标
主要结局
Overall survival
时间窗: From the date of randomization until the date of death from any cause，assessed up to 36 months
次要结局
- Disease free survival(From the date of randomization until the date of first documented progression，assessed up to 36 months)
研究者
Xin Ye
Shandong Provincial Hospital affliated to Shandong University
Shandong Provincial Hospital