A Prospective Randomized Study to Compare Cognitive Outcome After Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Patients With 11-20 Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Cognitive decline at 3 months
研究概览
简要总结
Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been increasingly employed in the management of multiple BM to spare healthy tissue. Hence, GKRS is expected to cause fewer cognitive side effects than WBRT. Treatment of multiple BM without cognitive side effects is becoming more important, as more patients live longer due to better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple BM, including objective neuropsychological testing.
CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM.
详细描述
CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM on a triple dose gadolinium-enhanced MRI-scan. Neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12 and 15 months after treatment. Follow-up assessments will be combined with 3-monthly MRI-scans.
Patients will be randomized to either GKRS or WBRT. Groups will be balanced at baseline (prior to radiotherapy), taking into account several (stratification) factors that may influence cognitive functioning over time, such as: total tumor volume in the brain, systemic treatment, KPS, age, histology, and baseline HVLT-R total recall score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically proven malignant cancer
- •11-20 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 (SCLC)
- •Meningeal disease
- •Progressive, symptomatic systemic disease without further treatment options
- •Prior brain radiation
- •Prior surgical resection of BM
- •Cardiovascular accident (CVA) < 2 years ago
- •Additional history of a significant neurological or psychiatric disorder
- •Contra indications to MRI or gadolinium contrast
- •Underlying medical condition precluding adequate follow-up
- •Participation in a concurrent study in which neuropsychological testing and/or health-related QOL assessments are involved
- •Lack of basic proficiency in Dutch
- •IQ below 85
- •Severe aphasia
- •Paralysis grade 0-3 according to MRC scale (Medical Research Council)
研究组 & 干预措施
Stereotactic radiosurgery (SRS)
Gamma Knife radiosurgery
干预措施: Gamma Knife radiosurgery (Radiation)
Whole Brain Radiation Therapy (WBRT)
Whole Brain Radiation Therapy
干预措施: Whole Brain Radiation Therapy (Radiation)
结局指标
主要结局
Cognitive decline at 3 months
时间窗: 3 months
Cognitive decline is defined as a significant decline (5 point decrease from baseline based on the Reliable Change Index (RCI) with correction for practice effects) in HVLT-R Total Recall score (verbal learning and memory test) after treatment with either GKRS or WBRT in patients with 11-20 brain metastases at time of treatment initiation.
次要结局
- Cognitive flexibility(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Word Fluency(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Working memory(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Fatigue(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Distant tumor control(12 months after GKRS/WBRT)
- Verbal memory(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Motor dexterity(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Health Related Quality Of Life (HRQOL)(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Depression and anxiety(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Median Overall Survival(12 months after GKRS/WBRT)
- Processing speed(Baseline and 3, 6, 9, 12 and 15 months post GKRS/WBRT)
- Local tumor control(12 months after GKRS/WBRT)