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5-20개의 뇌 전이가 있는 환자의 해마 보존 전체 뇌 방사선 대 정위 방사선: 3상, 무작위 시험

2026년 9월 4일 업데이트: Ayal A. Aizer, MD, Brigham and Women's Hospital

5-20개의 뇌 전이가 있는 환자의 해마 보존 전체 뇌 방사선 대 정위 방사선(SRS): 3상, 무작위 임상 시험

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)

연구 개요

상태

모집하지 않고 적극적으로

정황

상세 설명

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.

연구 유형

중재적

등록 (실제)

196

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Massachusetts
      • Boston, Massachusetts, 미국, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, 미국, 02116
        • Dana Farber Cancer Institute

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Whole Brain Radiation
  • MRI will be performed prior to radiation is administered
  • A hippocampal sparing approach will be used when possible
  • Dose will be 30 Gy in 10 fractions

Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.

실험적: Stereotactic Radiation (SRS)
  • MRI will be performed prior to radiation is administered
  • Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)

Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Score
기간: Baseline and 6 months post-Baseline

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

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Neurologic Death
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of New Brain Metastases
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Local Recurrence of Treated Brain Tumor(s)
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Progressive Intracranial Disease
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Radiographic Radiation Necrosis
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Leptomeningeal Disease
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Dexamethasone Initiation
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Development of Seizures
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Salvage Stereotactic Radiation
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Salvage Whole Brain Radiation
기간: Through study completion, an average of 1 year

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
12 Month Cumulative Incidence of Salvage Neurosurgical Resection
기간: Through study completion, an average of 1 year

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
Mean Barthel Index Score at Baseline
기간: Baseline

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
Change in Barthel Index Score at 4-months and 12-months Post-baseline
기간: 4 Months and 12 months

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
Karnofsky Performance Status
기간: Baseline to 12 Months

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
Hopkins Verbal Learning Test-Revised Total Recall Z-Score at Baseline
기간: Baseline

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
Change in Hopkins Verbal Learning Test-Revised Total Recall Mean Z-Score at 4-Months and 12-Months Post-baseline
기간: 4 Months and 12 Months

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
Hopkins Verbal Learning Test-Revised Delayed Recall Z-Score at Baseline
기간: Baseline

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
Change in Hopkins Verbal Learning Test-Revised Delayed Recall Z Scores at 4 Months and 12 Months
기간: 4 Months and 12 months post-baseline

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
Hopkins Verbal Learning Test-Revised Recognition Z Score at Baseline
기간: Baseline

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
Change in Hopkins Verbal Learning Test-Revised Recognition Z-score at 4 Months and 12 Months
기간: 4 Months and 12 Months post baseline

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
Trail Making Test A, Z Score at Baseline
기간: Baseline

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
Change in Trail Making Test A Z-Score From Baseline at 4 Months and 12 Months
기간: at 4 Months and 12 Months

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
Trail Making Test B Z Score at Baseline
기간: Baseline

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
Trail Making Test B Z Score at 4 Months and 12 Months Post-baseline
기간: 4 Months and 12 months post-baseline

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
Controlled Oral Word Test Z Score at Baseline
기간: Baseline

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
Change in Controlled Oral Word Test Z Score at 4 Months and 12 Months Post Baseline
기간: 4 Months and 12 months post baseline

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
Mini-Mental State Examination Mean at Baseline
기간: Baseline

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
Change in Mini-Mental State Examination Score at 4 Months and 12 Months Post Baseline
기간: 4 Months and 12 months post baseline

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
Medical Outcomes Study Cognitive Functioning Scale-Revised Normative Score at Baseline
기간: Baseline

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
Change in Medical Outcomes Study Cognitive Functioning Scale-Revised Normative Scores at 4 Months and 12 Months Post Baseline
기간: 4 Months and 12 months post baseline

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Ayal Aizer, MD MHS, Brigham and Women's Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 4월 10일

기본 완료 (실제)

2024년 11월 7일

연구 완료 (추정된)

2027년 9월 30일

연구 등록 날짜

최초 제출

2017년 3월 1일

QC 기준을 충족하는 최초 제출

2017년 3월 4일

처음 게시됨 (실제)

2017년 3월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 4일

마지막으로 확인됨

2026년 8월 1일

추가 정보

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예

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다