Radiofrequency Ablation of Pulmonary Tumors Response Evaluation: a Prospective, Intention-to-Treat, Multicenter Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 14
- 主要终点
- technical success
研究概览
简要总结
The study hypothesis is that the radiofrequency (RF) ablation is a safe and effective treatment for malignant lung tumors.
详细描述
Image-guided RF ablation is accepted as a viable therapeutic choice for patients with early-stage hepatocellular carcinoma or limited hepatic metastatic disease from colorectal cancer, when surgery is precluded (1, 2). Recently, RF ablation has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RF ablation in the destruction of experimentally-induced pulmonary malignancies (3). Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response (4, 5). We designed a prospective, intention-to-treat, multicenter clinical trial aimed at assessing feasibility, safety and effectiveness of RF ablation in the treatment of lung malignancies.
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
- •adult (> 18 years) male or female patient
- •patient has biopsy-proven NSCLC or lung metastasis
- •patient has been rejected for surgery and has been considered unfit for radiation therapy or chemotherapy
- •patient has as many as 3 tumors per lung, each 3.5 cm or smaller in greatest diameter, by CT scan
- •tumors are located at least 1 cm from trachea; main bronchi; esophagus; aorta; aortic arch branches; pulmonary artery; and heart
- •tumors are accessible by percutaneous route
- •patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •patient has platelet count > 100 x 109 /L and international normalized ratio ≤ 1.5
- •patient has signed written informed consent prior to any study specific procedures.
排除标准
- •patient has undergone previous pneumonectomy
- •patient is considered at high-risk for RF ablation due to major co-morbid medical conditions
- •patient has more than 3 tumors / lung
- •patient has at least one tumor > 3.5 in greatest diameter
- •tumor is associated with atelectasis or obstructive pneumonitis
- •patient has renal failure requiring hemodialysis or peritoneal dialysis
- •patient has active clinically serious infection
- •patient has history of organ allograft
- •patient has history of substance abuse or any medical, psychological or social conditions that may interfere with his / her participation in the study or evaluation of the study results
- •patient is pregnant or breast-feeding
- •patient has ECOG performance status > 2
- •patient has platelet count ≤ 100 x 109 /L or international normalized ratio > 1.5.
结局指标
主要结局
technical success
时间窗: immediate
complications
时间窗: 30 days
pulmonary function
时间窗: 2 years
tumor response
时间窗: 1 years
次要结局
- overall survival(2 years)
- cancer-specific survival(2 years)
- quality of life(2 years)