5-20 个脑转移瘤患者的海马保留全脑放疗与立体定向放疗:一项 III 期随机试验
海马保留全脑放疗与立体定向放疗 (SRS) 在 5-20 个脑转移瘤患者中的对比:一项 III 期随机临床试验
This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)
研究概览
详细说明
This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.
In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、美国、02116
- Dana Farber Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants must have a biopsy proven solid malignancy with untreated (by radiation) intracranial lesions radiographically consistent with or pathologically proven to be brain metastases. Patients who have undergone prior systemic therapy are eligible
- Five-twenty intracranial lesions must be present on MRI of the brain
- Age 18-80 years at diagnosis of brain metastases
- Karnofsky performance status of at least 70
Exclusion Criteria:
- Participants who have undergone prior radiation for brain metastases.
- Patients who have undergone resection of one or more brain metastases but who have not yet started adjuvant radiotherapy are eligible for the study
- Participants who cannot undergo a brain MRI
- Participants who cannot receive gadolinium (MRI contrast)
- Participants with stage IV-V chronic kidney disease or end stage renal disease
- Participants with widespread, definitive leptomeningeal disease
- Participants with small cell lung cancer, lymphoma, or myeloma
- Participants with a maximum tumor diameter exceeding 5 cm (if not resected)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Whole Brain Radiation
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Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation. |
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实验性的:Stereotactic Radiation (SRS)
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Focused radiation to each individual brain metastasis without treatment of the remainder of the brain. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Score
大体时间:Baseline and 6 months post-Baseline
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Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT). Results reflect patient-reported symptoms. Here they are presented as a mean change: the difference in the weighted mean of symptom severity and interference scores at baseline versus at 6 months. The difference between these scores is the mean change reported below. The MD Anderson Symptom Inventory has a scale of 0-10, 0 being not present and 10 being as bad as the patient could imagine. The calculated score change has a range of -10 to 10; -10 being the best. Change in score is calculated as the composite weighted means of symptom severity and interference at 6 months minus the composite weighted means of symptom severity and interference at baseline. |
Baseline and 6 months post-Baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Survival
大体时间:Through study completion, an average of 1 year
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Clinical Parameter. Here we report the number of patients analyzed for the outcome as well as the number of deaths that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Neurologic Death
大体时间:Through study completion, an average of 1 year
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Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic). Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of New Brain Metastases
大体时间:Through study completion, an average of 1 year
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Radiographic assessment of first appearance of new brain metastases. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Local Recurrence of Treated Brain Tumor(s)
大体时间:Through study completion, an average of 1 year
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Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Progressive Intracranial Disease
大体时间:Through study completion, an average of 1 year
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Radiographic assessment of first instance of progressive intracranial disease. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Radiographic Radiation Necrosis
大体时间:Through study completion, an average of 1 year
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Radiographic assessment of first appearance of radiation necrosis. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Leptomeningeal Disease
大体时间:Through study completion, an average of 1 year
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Radiographic assessment of first appearance of leptomeningeal disease. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Dexamethasone Initiation
大体时间:Through study completion, an average of 1 year
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Assessing time to dexamethasone initiation in patients who were not taking steroids at enrollment. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Development of Seizures
大体时间:Through study completion, an average of 1 year
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Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Salvage Stereotactic Radiation
大体时间:Through study completion, an average of 1 year
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Clinical assessment of first use of salvage stereotactic radiation. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Salvage Whole Brain Radiation
大体时间:Through study completion, an average of 1 year
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Clinical assessment of first use of salvage whole brain radiation with or without hippocampal avoidance. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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12 Month Cumulative Incidence of Salvage Neurosurgical Resection
大体时间:Through study completion, an average of 1 year
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Clinical assessment of first use of neurosurgical resection as salvage therapy. Here we report the number of patients analyzed for the outcome as well as the number of events that occurred. We then report the 12 Month Cumulative Incidence with a 95% Confidence Interval. |
Through study completion, an average of 1 year
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Mean Barthel Index Score at Baseline
大体时间:Baseline
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Barthel Index ranges from 0 to 100 with higher scores indicating greater functional independence. A greater difference between the groups indicates greater functional independence in the stereotactic arm. Here we report the mean Barthel Index score at baseline for both arms. |
Baseline
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Change in Barthel Index Score at 4-months and 12-months Post-baseline
大体时间:4 Months and 12 months
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Barthel Index ranges from 0 to 100 with higher scores indicating greater functional independence. A greater difference between the groups indicates greater functional independence in the stereotactic arm. Here we report the mean difference (95% Confidence Interval) at each timepoint. |
4 Months and 12 months
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Karnofsky Performance Status
大体时间:Baseline to 12 Months
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The Karnofsky Performance Status (KPS) is a tool designed to assess a cancer patient's functional status. Scores range from 0 to 100 with higher scores indicating better function. Scores 90-100 indicate that the patient is independent and can perform daily activities with little to no effort. A score of 80 indicates that the patient can conduct their normal activities with some effort. A score of 70 indicates that a patient can care for themself but cannot carry on normal activities independently. Here we report the least squares mean Karnofsky Performance Score for each arm based on the Karnofsky Performance Status Scale at each timepoint from Baseline to 12 Months post-baseline. |
Baseline to 12 Months
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Hopkins Verbal Learning Test-Revised Total Recall Z-Score at Baseline
大体时间:Baseline
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Here we report the mean Hopkins Verbal Learning Test-Revised Total Recall (HVLT-R Total Recall) z-score in each arm at baseline. The HVLT-R Total Recall test measures rote verbal learning across 3 trials administered in one sitting. Scores were transformed into z scores. Z scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The Z-Score central value is 0 and represents the population mean. Larger positive z scores indicate better neurocognitive function. |
Baseline
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Change in Hopkins Verbal Learning Test-Revised Total Recall Mean Z-Score at 4-Months and 12-Months Post-baseline
大体时间:4 Months and 12 Months
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Here we report the mean Hopkins Verbal Learning Test-Revised Total Recall (HVLT-R Total Recall) z-score in each arm at the given timepoint. The HVLT-R Total Recall test measures rote verbal learning across 3 trials administered in one sitting. Scores were transformed into z scores. Z scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The Z-Score central value is 0 and represents the population mean. Larger positive z scores indicate better neurocognitive function. |
4 Months and 12 Months
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Hopkins Verbal Learning Test-Revised Delayed Recall Z-Score at Baseline
大体时间:Baseline
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Here we report the mean Hopkins Verbal Learning Test-Revised Delayed Recall Z score at baseline. This test measures delayed memory function. Scores were transformed into z scores. Z scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The Z score central value is 0 and represents the population mean. Larger positive z scores indicate better neurocognitive function. |
Baseline
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Change in Hopkins Verbal Learning Test-Revised Delayed Recall Z Scores at 4 Months and 12 Months
大体时间:4 Months and 12 months post-baseline
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Here we report the mean Hopkins Verbal Learning Test-Revised Delayed Recall Z score at the given timepoint. This test measures delayed memory function. Scores were transformed into z scores. Z scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The Z score central value is 0 and represents the population mean. Larger positive z scores indicate better neurocognitive function. |
4 Months and 12 months post-baseline
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Hopkins Verbal Learning Test-Revised Recognition Z Score at Baseline
大体时间:Baseline
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Here we report the mean Hopkins Verbal Learning Test-Revised Recognition z scores in each arm at baseline. The Hopkins Verbal Learning Test - Revised Recognition measures memory storage and recognition. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the populaion mean. Larger, positive z scores indicate better neurocognitive function. Here we report the mean z score in each arm at baseline. |
Baseline
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Change in Hopkins Verbal Learning Test-Revised Recognition Z-score at 4 Months and 12 Months
大体时间:4 Months and 12 Months post baseline
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Here we report the mean Hopkins Verbal Learning Test-Revised Recognition z scores in each arm at the given timepoint. The Hopkins Verbal Learning Test - Revised Recognition measures memory storage and recognition. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the populaion mean. Larger, positive z scores indicate better neurocognitive function. Here we report the mean z score in each arm at the given timepoint. |
4 Months and 12 Months post baseline
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Trail Making Test A, Z Score at Baseline
大体时间:Baseline
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Here we report the mean Trail Making Test A z score in each arm at baseline. The Trail Making Test A measures visuomotor processing speed. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the population mean. Larger, positive z scores inicate better visuomotor processing speed. |
Baseline
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Change in Trail Making Test A Z-Score From Baseline at 4 Months and 12 Months
大体时间:at 4 Months and 12 Months
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Here we report the mean Trail Making Test A z score in each arm at the given timepoint. The Trail Making Test A measures visuomotor processing speed. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the population mean. Larger, positive z scores inicate better visuomotor processing speed. |
at 4 Months and 12 Months
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Trail Making Test B Z Score at Baseline
大体时间:Baseline
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Here we report the mean Trail Making Test B z score in each arm at baseline. The Trail Making Test B measures visuomotor processing speed. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the population mean. Larger, positive z scores inicate better visuomotor processing speed. |
Baseline
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Trail Making Test B Z Score at 4 Months and 12 Months Post-baseline
大体时间:4 Months and 12 months post-baseline
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Here we report the mean Trail Making Test B z score in each arm at the given timepoint. The Trail Making Test B measures visuomotor processing speed. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the population mean. Larger, positive z scores inicate better visuomotor processing speed. |
4 Months and 12 months post-baseline
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Controlled Oral Word Test Z Score at Baseline
大体时间:Baseline
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Here we report the mean controlled oral word test z score in each arm at baseline. The controlled oral word test (COWAT) measures verbal fluency. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the population mean. A larger positive z score indicates better performance. |
Baseline
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Change in Controlled Oral Word Test Z Score at 4 Months and 12 Months Post Baseline
大体时间:4 Months and 12 months post baseline
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Here we report the change in mean controlled oral word test z score in each arm at the given timepoints from baseline. The controlled oral word test (COWAT) measures verbal fluency. Scores were transformed into z scores. z Scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The z score central value is 0 and represents the population mean. A larger positive z score indicates better performance. |
4 Months and 12 months post baseline
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Mini-Mental State Examination Mean at Baseline
大体时间:Baseline
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Here we report the Mini-Mental State Examination mean in each arm at baseline. The Mini-Mental State Examination measures global cognition on a scale from 0 to 30. Higher scores indicate better perfromance. |
Baseline
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Change in Mini-Mental State Examination Score at 4 Months and 12 Months Post Baseline
大体时间:4 Months and 12 months post baseline
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Here we report the change in the mean Mini-Mental State Examination z score in each arm at the given timepoints. The Mini-Mental State Examination Scores measures global cognition on a scale from 0 to 30. Test scores were transformed into z scores Larger positive scores indicate better performance. Z scores greater than 2.0 indicate exceptionally high function, between 1.36 and 2.0 indicate above average function, between 0.68 and 1.35 indicate high average function, between -0.67 and 0.67 indicate average function, between -0.68 and -1.35 indicate low average function, between -1.36 and -2.0 indicate below average function, and less than -2.0 indicate exceptionally low. The Z-Score central value is 0 and represents the population mean. Larger, positive differences indicate better global cognition. |
4 Months and 12 months post baseline
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Medical Outcomes Study Cognitive Functioning Scale-Revised Normative Score at Baseline
大体时间:Baseline
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Scores global cognition on a scale from 0 to 100. Higher scores indicate better cognitive function. Scores were transformed into normative scores ranging from 7.51 to 58.61. Larger scores indicate better function. |
Baseline
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Change in Medical Outcomes Study Cognitive Functioning Scale-Revised Normative Scores at 4 Months and 12 Months Post Baseline
大体时间:4 Months and 12 months post baseline
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Scores global cognition on a scale from 0 to 100. Higher scores indicate better cognitive function. Scores were transformed into normative scores ranging from 7.51 to 58.61. Larger positive differences indicate better function. |
4 Months and 12 months post baseline
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合作者和调查者
调查人员
- 首席研究员:Ayal Aizer, MD MHS、Brigham and Women's Hospital
出版物和有用的链接
一般刊物
- Ayal Aizer et al. Stereotactic radiation versus hippocampal avoidance whole brain radiation in patients with 5-20 brain metastases: A multicenter, phase 3 randomized trial.. J Clin Oncol 43, 2011-2011(2025). DOI:10.1200/JCO.2025.43.16_suppl.2011
- Aizer A et al. Multicenter, Phase 3 Randomized Trial of Stereotactic Radiation vs. Hippocampal Avoidance Whole Brain Radiation in Patients with 5-20 Brain Metastases: Recurrence, Salvage Therapy, and Mortality Endpoints International Journal of Radiation Oncology, Biology, Physics, 123, S33-S34
- Michael Parsons, Kee-Young Shin, Jennifer Nosker, Shyam Tanguturi, Paul Catalano, Daphne Haas-Kogan, Jaroslaw Hepel, Marciana Johnson, Grant Benham, Ivy Ricca, Rifaquatn Rahma, Ayal Aizer, NCOG-20. Stereotactic radiation versus hippocampal avoidant whole brain radiation in patients with 5-20 brain metastases: Cognitive outcomes of 12-month survivors, Neuro-Oncology, Volume 27, Issue Supplement_5, November 2025, Pages v325-v326, https://doi.org/10.1093/neuonc/noaf201.1287
- Aizer AA, Shin KY, Catalano PJ, Ricca I, Johnson M, Benham G, Roper K, Spicer B, Mann E, Nosker J, Parsons MW, Mendu ML, Hepel J, Chipidza F, Krishnan M, Shi DD, Lamba N, Pashtan I, Peng L, Alexander B, Brown PD, Wen PY, Haas-Kogan DA, Rahman R, Tanguturi S. Treatment for Brain Metastases With Stereotactic Radiation vs Hippocampal-Avoidance Whole Brain Radiation: A Randomized Clinical Trial. JAMA. 2026 Apr 7;335(13):1127-1136. doi: 10.1001/jama.2026.0076.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
- 泌尿生殖系统疾病
- 脑部疾病
- 中枢神经系统疾病
- 神经系统疾病
- 病理过程
- 泌尿生殖系统肿瘤
- 按部位分类的肿瘤
- 肿瘤
- 男性泌尿生殖系统疾病
- 肾脏疾病
- 泌尿系统疾病
- 女性泌尿生殖系统疾病
- 女性泌尿生殖系统疾病和妊娠并发症
- 疾病属性
- 呼吸道疾病
- 组织学类型的肿瘤
- 肺部疾病
- 肿瘤、腺体和上皮
- 腺癌
- 呼吸道肿瘤
- 胸部肿瘤
- 皮肤病
- 乳腺疾病
- 泌尿系肿瘤
- 癌
- 神经外胚层肿瘤
- 肿瘤、生殖细胞和胚胎
- 肿瘤,神经组织
- 神经系统肿瘤
- 神经内分泌肿瘤
- 痣和黑色素瘤
- 皮肤肿瘤
- 中枢神经系统肿瘤
- 病理状况、体征和症状
- 皮肤和结缔组织疾病
- 复发
- 肺肿瘤
- 乳腺肿瘤
- 癌,肾细胞
- 黑色素瘤
- 脑肿瘤
- 肾脏肿瘤
- 调查技术
- 疗法
- 手术程序,手术
- 酶
- 酶和辅酶
- 放疗
- 立体定位技术
- 神经外科手术
- 转移酶
- 烷基和芳基转移酶
- 放射外科手术
- 精子合酶
其他研究编号
- 16-305
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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