Radiofrequency Ablation in Resectable Colorectal Lung Metastasis: A Phase-II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 32
- 主要终点
- Primary Outcome Measures:3-year survival
研究概览
简要总结
Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this phase-II trial, clinical utility of lung RF ablation will be evaluated in patients with resectable colorectal lung metastases.
详细描述
This will be a phase-II clinical trial.
Lung metastasectomy is the only therapeutic option to provide a long-survival in patients with colorectal lung metastases. Recent studies have shown that radiofrequency (RF) ablation is a safe and useful therapeutic option for the treatment of unresectable lung metastases. In this clinical trial, clinical utility of lung RF ablation will be evaluated.
Patients with resectable lung metastases will receive lung RF ablation.
All subjects will be followed for overall survival, safety, change in respiratory function, cancer-specific survival, and local tumor progression.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary lesions (colorectal cancer) are resected.
- •Lung metastases appear.
- •No extrapulmonary metastases or after locoregional treatments.
- •Lung metastasis is considered to be controllable either by metastasectomy or radiofrequency (RF) ablation.
- •Five or less lung metastases measuring 3cm or smaller.
- •PET study within 8 weeks before metastasectomy or RF ablation.
- •White blood count of 3000/mm3 or more.
- •Platelet count of 100,000/mm3 or more.
- •Hemoglobin level of 8.0 g/dl.
- •Serum creatinine level of 2.0 mg/dl or less.
- •PaO2 of 70 mm Hg or more（Room air）or SpO2 of 93%.
- •Serum bilirubin level of 2.0 mg/dl or less.
- •Performance status of 0 or
- •Expected survival of 1 year or more.
- •Age of 20 years or more.
- •Informed consent from the patient.
排除标准
- •Risk to injure lung vessels 5 mm or larger.
- •Lung metastases adjacent to the heart, trachea, esophagus, and aorta.
- •Association of uncontrollable malignancies.
- •Lung hilar lymph node metastasis.
- •One lung.
- •Pulmonary hypertension.
- •Coagulopathy.
- •Impossible to stop using anticoagulants.
- •Active infection or C-reactive protein of 3 or higher.
- •Association of active inflammation.
- •Fever (higher than 38 degrees celsius).
- •Previous external-beam radiotherapy for the treated lung.
- •Pregnant.
- •Judgment to be an inappropriate candidate by a attending physician.
研究组 & 干预措施
Lung radiofrequency ablation
A radiofrequency (RF) electrode is placed in the lung metastasis percutaneously. RF energy is applied to the tumor to induce coagulation necrosis.
干预措施: Lung radiofrequency ablation (Device)
结局指标
主要结局
Primary Outcome Measures:3-year survival
时间窗: 3 years
次要结局
- Secondary Outcome measures:safety, change in respiratory function, cancer-specific survival, and local tumor progression, Radiological studies(3 years)
研究者
Koichiro Yamakado
instructor of Department of Interventional Radiology
Mie University