NCT01233544终止3 期
The International Liver Tumor Group RAS-trial Radiofrequency Ablation Versus Stereotactic Body Radiation Therapy for Colorectal Liver Metastases: A Randomized Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Local progression-free survival
研究概览
简要总结
This randomized clinical phase III trial is testing the efficacy of radiofrequency ablation (RFA) and stereotactic body radiotherapy (SBRT) in the treatment of colorectal carcinoma liver metastases.
Primary end point is local progression free survival.
详细描述
Patients with 1-4 inoperable colorectal liver metastases, no more 4 cm in diameter are randomized to either RFA or SBRT. Primary end point i local progression free survival. Chemotherapy is allowed before and after study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the colon or rectum
- •Liver metastases
- •Inoperable (technical or medical)
- •1-4 metastases
- •Maximum 40 mm in diameter
- •Suitable for both therapies, RFA and SBRT
排除标准
- •Uncontrolled extrahepatic disease and uncontrolled primary cancer
- •Liver cirrhosis
结局指标
主要结局
Local progression-free survival
时间窗: 3 years
次要结局
- Survival(3 years)
- Progression (local or distant)(3 years)
- Toxicity(3 years)
- Quality of life(3 years)
研究者
研究点 (4)
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