Local Radiotherapy Following Complete Resection of a Brain Metastasis
Postoperative Local Stereotactic Radiotherapy Versus Observation Following a Complete Resection of a Single Brain Metastasis
Objective: To improve local control following complete resection of a single brain metastasis using fractionated local stereotactic radiotherapy, whilst maintaining neurological functioning, neurocognition and quality of life.
Study design: Multicenter randomized phase III, with at least three high-volume Dutch centers participating in the trial. Stratification on primary tumor type and age.
Study population: Patients undergoing complete resection of a single brain metastasis, confirmed by an early (i.e. within 72 hours) postoperative contrast-enhanced MR scan.
Study intervention: Patients will be randomized between observation alone (standard arm) and local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity (study arm).
Main study parameters: Primary objective: local control rate at 6 months. Secondary objectives: local control rate at 12 months, neurological functioning, freedom from clinical neurological progression, performance status, quality of life, toxicity, steroid use, neurocognition and overall survival.
研究概览
详细说明
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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Amsterdam、荷兰、1066CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek
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Amsterdam、荷兰、1081HV
- VU University Medical Center
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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:
- Age of 18 years or older.
- Radiologically confirmed complete resection of a single brain metastasis on a contrast-enhanced MRI within 72 h after resection.
- Primary solid tumor, excluding hematologic malignancy, germ cell tumor, small cell lung cancer.
- Stable extracranial tumor (primary tumor and/or systemic metastases) during the last three months with or without treatment or progressive extracranial tumor and/or systemic metastases for which effective treatment is available.
- World Health Organization (WHO) performance score 0-2.
- Ability to provide written informed consent.
Exclusion Criteria:
- Prior treatment for brain metastases (i.e. surgery, stereotactic radiotherapy or WBRT).
- Distant brain metastases or radiological findings on MRI suspected for leptomeningeal tumor spread on the postoperative MRI.
- Concurrent use of systemic therapy during local stereotactic radiotherapy
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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无干预：observation
Watchful waiting
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有源比较器：local stereotactic radiotherapy (SRT)
local SRT in three fractions of 8 Gy to the surgical cavity
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local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity
其他名称：
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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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local control rate
大体时间：at 6 months
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as assessed on follow-up MRI scans
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at 6 months
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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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Decrease in neurocognitive test results using the Hopkins Verbal Learning Test Revised (HVLT-R), in full cohorts
大体时间：baseline, at 3 months, 6 months and 12 months
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Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Hopkins Verbal Learning Test Revised (HVLT-R).
The HVLT-R is one of the components used to form the core set of cognitive tests recommended to use in oncology trials.
This test measures immediate memory span, provides a learning curve, measures both short-term and longer-term retention, and allows for a comparison between retrieval efficiency and learning.
This version includes 3 learning trials of a 12-word list, an interval of 20 minutes a delayed recall, and a recognition trial consisting of the target words interspersed with distractor words.
The score on the recognition trial is the total number of correct response.
This measure has adequate psychometric properties and 6 multiple forms.
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baseline, at 3 months, 6 months and 12 months
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Decrease in specified neurocognitive test results using the Trail Making A and B, in full cohorts
大体时间：baseline, at 3 months, 6 months and 12 months
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Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Trail Making A and B. This test is one of the components used to form the core set of cognitive tests recommended to use in oncology trials.
This is a test of visual conceptual and visuomotor tracking.
It measures psychomotor speed and aspects of executive function.
It is given in two parts, A and B. The subject must first draw lines to connect consecutively numbered circles on one work sheet (part A) and then connect the same number of consecutively numbered and lettered circles on another worksheet by alternating between the two sequences (part B).
The subject is urged to connect the circles as fast as possible
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baseline, at 3 months, 6 months and 12 months
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Decrease in neurocognitive test results using the Controlled Oral Word Association (COWA), in full cohorts
大体时间：baseline, at 3 months, 6 months and 12 months
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Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Controlled Oral Word Association (COWA).
The COWA is one of the components used to form the core set of cognitive tests recommended to use in oncology trials.
This test measures speeded verbal fluency and aspects of executive function.
In this test, subjects are asked to generate as many words as possible in 1 minute beginning with "B", "D," and "H".
It has two forms.
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baseline, at 3 months, 6 months and 12 months
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Decrease in neurocognitive test results using using the Wechsler Adult Intelligence Scale (WAIS) III Digit Span and WAIS III Digit Symbol, in full cohorts
大体时间：baseline, at 3 months, 6 months and 12 months
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Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the WAIS III Digit Span and WAIS III Digit Symbol. These added cognitive tests are also chosen based on their proven sensitivity to measure change in neuro-oncology patients. The subtest of the WAIS-III (Digit Span) involves forward and backward repetitions of series of digits and provides measures of concentration. This measure has adequate psychometric properties. The subtest of the WAIS III (Digit Symbol) involves a symbol substitution task that requires visual-motor coordination, motor persistence, and sustained attention. The test is used as a test for information processing speed. The task consists of pairing numbers to nonsense symbols as quickly as possible. |
baseline, at 3 months, 6 months and 12 months
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Decrease in neurocognitive test results using the Grooved Pegboard, in full cohorts
大体时间：baseline, at 3 months, 6 months and 12 months
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Neurocognitive testing will be performed at baseline, at three, six and twelve months follow-up using the Grooved Pegboard.
This added cognitive test is also chosen based on its proven sensitivity to measure change in neuro-oncology patients.
This test measures motor speed and dexterity and is an adjusted version of the Purdue Pegboard test.
The test consists out of plywood with 2 columns of 30 holes and a zinced bowl filled with metal pegs above each column.
Subjects are offered one minute to put as many pegs as possible into the holes.
The test has two different trials: dominant hand only and non-dominant hand only.
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baseline, at 3 months, 6 months and 12 months
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合作者和调查者
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 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
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