A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 235
- 主要终点
- Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks
研究概览
简要总结
RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy.
PURPOSE: This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine whether the addition of memantine hydrochloride to whole-brain radiotherapy (WBRT) preserves cognitive function, specifically memory, as measured by the Hopkins Verbal Learning Test for delayed recall (HVLT-delayed recall), over that of placebo and WBRT in patients with brain metastases at 24 weeks from the start of drug treatment.
Secondary
- Determine whether the addition of memantine hydrochloride preserves cognitive function, specifically memory, as measured by the HVLT-delayed recall at 8 weeks, 16 weeks, and 12 months from the start of drug treatment.
- Determine whether the addition of memantine hydrochloride increases time to neurocognitive failure as measured by cognitive decline on a battery of tests including the HVLT for free recall, delayed recall, and delayed recognition; the Controlled Word Association Test (COWAT); the Trail Making Test Parts A and B (TMT); the Medical Outcomes Scale-Cognitive Functioning Subscale (MOS); and the Mini-Mental Status Examination (MMSE).
- Evaluate the potential benefit of memantine hydrochloride in change and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) subscale.
- Determine whether the addition of memantine hydrochloride increases progression-free survival.
- Determine whether the addition of memantine hydrochloride increases overall survival.
- Compare adverse events between the treatment arms according to the CTCAE v3.0 criteria.
- Collect serum, plasma, buffy coat cells, urine, and cerebrospinal fluid (CSF) for future translational research analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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+Memantine
Whole brain radiation therapy (WBRT) and memantine
干预措施: Memantine (Drug)
WBRT+Memantine
Whole brain radiation therapy (WBRT) and memantine
干预措施: Whole brain radiation therapy (Radiation)
WBRT+Placebo
Whole brain radiation therapy (WBRT) and placebo
干预措施: Placebo (Other)
WBRT+Placebo
Whole brain radiation therapy (WBRT) and placebo
干预措施: Whole brain radiation therapy (Radiation)
结局指标
主要结局
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks
时间窗: Baseline and 24 weeks from the start of drug treatment
The HVLT-R consists of 3 parts. Free call has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from 24-week value. Imputation methods were used to determine values for all alive patients missing the 24 week assessment. This tool is being used to measure cognitive function, specifically memory.
次要结局
- Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 8, 16, and 52 Weeks(Baseline, 8, 16, and 52 weeks from the start of drug treatment)
- Median Time to Neurocognitive Failure(Baseline to 12 months from the start of drug treatment)
- Change in Functional Assessment of Cancer Therapy With Brain Subscale (FACT-Br) at 24 Weeks(Baseline and 24 weeks from start of treatment)
- Median Progression-free Survival Time(From randomization to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.)
- Overall Survival(From randomization to date of death or last follow-up. Analysis occurs at the same time as the primary outcome. Patients are followed until death and all follow-up collected at time of analysis is used.)