A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 126
- 主要终点
- Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
研究概览
简要总结
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain radiation therapy works in treating patients with brain metastases.
详细描述
OBJECTIVES:
Primary
- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) at 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) in patients with brain metastasis.
Secondary
- Evaluate auditory and visual learning and memory, as assessed by two CogState tests (International Shopping List Test and One Card Learning Test), after HA-WBRT in these patients.
- Compare psychometric properties of the 2 CogState tests to the HVLT-R for the assessment of memory decline after HA-WBRT in these patients.
- Evaluate health-related quality of life [as assessed by the Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR) and the Barthel Index of Activities of Daily Living (ADLs)] after HA-WBRT in these patients.
- Evaluate time to radiographic progression after HA-WBRT in these patients.
- Evaluate overall survival of these patients after HA-WBR.
- Evaluate the adverse events of HA-WBR.
- Evaluate predictive biomarkers of cognitive function.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
WBRT with Hippocampal Avoidance
Whole brain radiotherapy (WBRT) with hippocampal avoidance using intensity-modulated radiation therapy (IMRT)
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)
时间窗: Baseline and 4 months from start of treatment
Change in Hopkins Verbal Learning Test-Revised delayed recall (HVLT_R DR) score from baseline to 4 months after the start of treatment calculated as (baseline score - 4 month score)/ baseline score. A positive change indicates a decline in function. The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms, helping to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. Delayed recall involves recalling a list of 12 targets after a 20-minute delay. The score is the sum of the number of targets correctly recalled. Percent change calculated as 100\*\[(baseline score - 4 month score)/ baseline score\]
次要结局
- Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)(Baseline and 4 months from start of treatment)
- ApoE4 Genotype and Other Potentially Predictive Biomarkers of Cognitive Function(Baseline and 4 months from start of treatment)
- Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT)(Baseline and 4 months from start of treatment)
- Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT)(Baseline and 4 months from start of treatment)
- Progression-free Survival(Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.))
- Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL)(Baseline and 4 months from start of treatment)
- Overall Survival(Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.))
- The Frequency of Patients With Grade 3 and Higher Adverse Events (AE) Related to Treatment(From start of treatment to 12 months from start of treatment)