NCT00107367Unknown1 期
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Local control rate as measured by MRI with contrast at 1 year
研究概览
简要总结
RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.
详细描述
OBJECTIVES:
Primary
- Determine the 1-year local control rate in patients undergoing resection of a solitary brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.
Secondary
- Determine the survival of patients treated with this therapy.
- Determine distant recurrence of disease in patients treated with this therapy.
- Determine the toxicity of this therapy in these patients.
- Determine the quality of life of patients treated with this therapy.
研究设计
- 研究类型
- Interventional
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Local control rate as measured by MRI with contrast at 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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