Cognitive Outcome After Gamma Knife Radiosurgery in Patients With 1-10 Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change in cognitive flexibility
研究概览
简要总结
Stereotactic radiosurgery (SRS) is increasingly applied in patients with brain metastases (BM) and is expected to have less adverse effects on cognitive functioning than Whole Brain Radiation Therapy (WBRT). Because cognitive functions are essential for daily functioning, and may affect therapy compliance and quality of life in general, a full understanding of cognitive functioning in patients with BM after SRS is essential.
CAR-Study A is a prospective study to evaluate cognitive functioning in patients with 1-10 BM accepted for treatment with Gamma Knife radiosurgery (GKRS).
详细描述
CAR-Study A is a prospective study to evaluate cognitive functioning after GKRS in patients with 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan. Neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12, 15, and 21 months after treatment. Follow-up assessments will be combined with 3-monthly MRI-scans.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Histologically proven malignant cancer
- •1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan
- •Maximum total tumor volume 30 cm3
- •Lesion ≥ 3 mm from the optic apparatus
- •Age ≥ 18 years
- •Karnofsky Performance Status (KPS) ≥ 70
- •Anticipated survival > 3 months
排除标准
- •No prior histologic confirmation of malignancy
- •Primary brain tumor
- •A second active primary tumor
- •Small cell lung cancer
- •Meningeal disease
- •Progressive, symptomatic systemic disease without further treatment options
- •Prior brain radiation
- •Prior surgical resection of brain metastases
- •Additional history of a significant neurological or psychiatric disorder
- •Participation in a concurrent study in which neuropsychological testing and/or health-related QOL assessments are involved
- •Contra indications to MRI or gadolinium contrast
- •Underlying medical condition precluding adequate follow-up
- •Lack of basic proficiency in Dutch
- •IQ below 85
- •Severe aphasia
- •Paralysis grade 0-3 according to MRC scale (Medical Research Council)
结局指标
主要结局
Change in cognitive flexibility
时间窗: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Cognitive flexibility is measured with the Trail Making Test B (TMT B)
Change in verbal memory
时间窗: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Verbal memory is measured with the Hopkins Verbal Learning Test-Revised (HVLT-R)
Change in working memory
时间窗: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Working memory is measured with the Wechsler Adult Intelligence Scale - Digit Span
Change in processing speed
时间窗: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Processing speed is measured with the Wechsler Adult Intelligence Scale - Digit Symbol
Change in word fluency
时间窗: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Word Fluency is measured with the Controlled Oral Word Association (COWA)
Change in motor dexterity
时间窗: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Motor dexterity is measured with the Grooved Pegboard (GP)
次要结局
- Fatigue(Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS)
- Health Related Quality Of Life (HRQOL)(Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS)
- Median Overall Survival(12 months after GKRS)
- Distant tumor control(12 months after GKRS)
- Local tumor control(12 months after GKRS)
- Depression and anxiety(Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.)