A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tumor status
研究概览
简要总结
The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus).
The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.
详细描述
The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Perioptic lesion within 2mm of the optic apparatus
- •Age >= 21
- •KPS >= 50
- •Planning Target Volume (PTV) <= 6.0 cm in maximal diameter
排除标准
- •Malignant histology
- •Age < 21
- •KPS <= 40
- •Planning Target Volume (PTV) > 6.0 cm in maximal diameter
- •Prior whole brain XRT
- •Gross total resection
研究组 & 干预措施
CyberKnife Radiosurgery
干预措施: CyberKnife Radiosurgery (Radiation)
结局指标
主要结局
Tumor status
时间窗: 5 years
To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.
次要结局
未报告次要终点
