Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Hopkins Verbal Learning Test - Revised (HVLT-R)
研究概览
简要总结
Cancer which spreads to the brain (brain metastases) is a common and significant problem. Historically, whole-brain radiotherapy has been used to treat these patients but has a negative effect on cognition. Radiosurgery is an alternative treatment with potential for fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of patients with multiple brain metastases is not well studied. We propose a pilot study at the Winnipeg Centre for Gamma Knife Surgery to examine this issue.
详细描述
Patients with >=4 brain metastases will undergo Gamma Knife radiosurgery to a dose of 15-20 Gy, depending on the maximum tumour diameter and number of metastases. A number of neurocognitive, quality of life, and toxicity assessments will be performed at baseline and at 6 weeks post-radiosurgery, then at months 4, 6, 12, 18, and every 6 months thereafter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Pathologically proven solid tumour malignancy
- •Age >= 18 years
- •Karnofsky performance status >= 70
- •>= 4 brain metastases, all eligible to be treated with radiosurgery
- •All brain metastases <= 4.0 cm in any diameter
- •Pre-treatment contrast enhanced MRI brain <= 42 days prior to enrollment
- •Patient able to provide his/her own written informed consent
排除标准
- •Prior radiosurgery, whole brain radiotherapy, or cranial radiotherapy
- •Previous surgical resection of brain metastasis (biopsy is allowed)
- •Prior chemotherapy ≤ 7 days prior to enrollment
- •Planned chemotherapy during radiosurgery
- •Leukemia, lymphoma, germ-cell tumour, small-cell lung cancer diagnosis
- •Brainstem metastasis
- •Leptomeningeal metastases
- •Contraindication to MR imaging with contrast
- •Pregnant or nursing women
结局指标
主要结局
Hopkins Verbal Learning Test - Revised (HVLT-R)
时间窗: 4 months after radiosurgery
次要结局
- Quality of Life(4 months after radiosurgery)
- Neurocognitive battery(4 months after radiosurgery)
- Common Terminology Criteria for Adverse Events (CTCAE) v4.0(4 months after radiosurgery)