A Phase II Study of Radiofrequency Ablation of Lung Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incomplete local treatment
研究概览
简要总结
Radiofrequency ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung cancer or lung metastases).
详细描述
Radiofrequency (RF) ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that RF can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms with a minimal follow-up of one year. The primary endpoint was to determine the rate of incomplete local treatment at 1 year. The secondary endpoints were to evaluate tolerance, survival, disease-free survival and lung tumor-free survival. Patients are followed-up by CT scan examination at day 1 or 2 before discharge from the hospital, then at 2, 4, 6, 9 and 12 months and then at 2 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Unilateral or bilateral unresectable primary or metastatic lung tumors <= 40 mm and a number of tumor <=5
- •Tumors located more than 1 cm from the hilum, and not involving soft tissues or mediastinum.
- •Malignancy histologically proven for pulmonary nodules in patients with no history of cancer outside the lung.
- •Lung tumors in patients with a known distant cancer history, has to be either histologically proven or a demonstrated change in size of at least 25% in their largest diameter is required on CT during the previous year
- •Pretreatment imaging work-up within 4 weeks of scheduled RF ablation (at least a chest CT and an abdomino-pelvic CT)
- •If a tumor is found outside the lung, it has to be amenable to complete eradication with RF or RF plus surgery
- •Lung spirometry within 4 weeks of treatment with a FEV1 >= 1 liter
- •Written informed consent.
排除标准
- •Uncorrectable coagulopathy with a prothrombin time greater than 1.5 and a platelet count below 106/mm3
结局指标
主要结局
Incomplete local treatment
次要结局
- Survival
- Lung disease-free survival