A Prospective Study of Radiofrequency Ablation Combined With Chemotherapy for Pulmonary Tumors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to assess short and long term outcomes after radiofrequency ablation (RFA) combined with chemotherapy for pulmonary malignancies in patients who are not candidates for surgical resection. This study will evaluate the efficacy of RFA combined with chemotherapy for the treatment of lung tumors by assessing its impact on local tumor control, progression free survival, overall survival, dyspnea score and quality of life (QOL).
详细描述
Percutaneous image-guided RFA is a minimally invasive technique used to treat solid tumours. Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies. Recently, RFA has been proposed as a viable option for the treatment of pulmonary malignancies. Experimental studies in animal tumor models have confirmed the effectiveness of RFA in the destruction of experimentally-induced pulmonary malignancies. Pilot clinical investigations have suggested that the treatment can achieve high proportions of tumor response. We designed a prospective clinical trial aimed at assessing feasibility, safety and effectiveness of RFA combined with chemotherapy in the treatment of lung malignancies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
- •each 6 cm or smaller in greatest diameter of tumor, 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 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 > 6 cm 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
Progression-free survival
时间窗: 3 months
次要结局
- Overall survival(3 months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(30 days)