NCT01476878Unknown1 期
Frameless Stereotactic Radiosurgery for Brain Metastases
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quantification of patient movement occurring during treatment.
研究概览
简要总结
The investigators plan to study high dose, single treatment radiation, using a plastic mask instead of a head frame that pins into a patient's skull. The investigators need to (1) quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that without the head frame the tumour control rate and risk of complications are similar to our previous experience using the head frame.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies.
- •One to four metastases, and all lesions < 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70
排除标准
- •None of the lesions is abutting or within critical neurological structures: *brainstem
- •optic chiasm
- •eye, and optic nerve.
- •The clearance between metastatic lesions and all critical structures must be at least 2 mm.
- •Patients must not have leptomeningeal disease.
- •Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).
结局指标
主要结局
Quantification of patient movement occurring during treatment.
时间窗: overall
次要结局
- Local tumour control(overall)
- risk of complication (radionecrosis)(overall)
研究者
研究点 (2)
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