Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
연구 개요
상세 설명
OBJECTIVES:
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
- Compare the time to CNS failure (brain) in patients treated with these regimens.
- Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
- Compare the post-treatment toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiosurgery.
- Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, 미국, 85013
- Foundation for Cancer Research and Education
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Phoenix, Arizona, 미국, 85001-2071
- St. Joseph's Hospital and Medical Center
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California
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Concord, California, 미국, 94524-4110
- Mount Diablo Regional Cancer Center
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Sacramento, California, 미국, 95816
- Sutter Cancer Center
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San Francisco, California, 미국, 94115
- UCSF Comprehensive Cancer Center
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Walnut Creek, California, 미국, 94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
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Colorado
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Aurora, Colorado, 미국, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Connecticut
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New Haven, Connecticut, 미국, 06520-8040
- Yale Comprehensive Cancer Center
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Florida
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Gainesville, Florida, 미국, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois Medical Center
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Iowa
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Davenport, Iowa, 미국, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, 미국, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, 미국, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, 미국, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New Jersey
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Edison, New Jersey, 미국, 08818
- John F. Kennedy Medical Center
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New York
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, 미국, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, 미국, 28232-2861
- Carolina Neurosurgery and Spine Associates
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Durham, North Carolina, 미국, 27705
- American College of Surgeons Oncology Group
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Winston-Salem, North Carolina, 미국, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, 미국, 15212-4772
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, 미국, 15215
- UPMC St. Margaret
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Pittsburgh, Pennsylvania, 미국, 15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
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Tennessee
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Memphis, Tennessee, 미국, 38104
- Methodist Cancer Center at Methodist University Hospital
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Utah
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American Fork, Utah, 미국, 84003
- American Fork Hospital
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Virginia
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Charlottesville, Virginia, 미국, 22908
- Cancer Center at the University of Virginia
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Richmond, Virginia, 미국, 23298-0631
- Massey Cancer Center at Virginia Commonwealth University
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Wisconsin
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Madison, Wisconsin, 미국, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Diagnosis of cerebral metastases meeting all of the following requirements:
- 1-3 de novo lesions
- Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s)
- Each lesion must be less than 3.0 cm by contrasted MRI of the brain
- Lesions must not be within 5 mm of optic chiasm or within the brainstem
- No primary germ cell tumor, small cell carcinoma, or lymphoma
- No leptomeningeal metastases
- Eligible for treatment with gamma knife or linear accelerator-based radiosurgery
- Performance status - ECOG 0-2
- Performance status - Zubrod 0-2
- Not pregnant
- Negative pregnancy test
Fertile patients must use effective contraception
* Male patients must continue to use contraception for 3 months after the completion of radiotherapy
- No pacemaker or other MRI-incompatible metal in body
- No known allergy to gadolinium
- Deemed to be at low risk for recurrence from any prior malignancies
- At least 7 days since prior chemotherapy
- Concurrent hormonal agents allowed
- Concurrent steroids allowed
- No prior cranial radiotherapy
- No prior resection of cerebral metastasis
- Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
공부 계획
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 |
|---|---|
|
실험적: radiosurgery
Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. |
|
|
실험적: radiosurgery + WBRT
Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Overall survival (OS)
기간: Up to 6 months
|
Up to 6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Time to CNS failure
기간: Up to 4 years
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Up to 4 years
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Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
기간: From baseline to up to 3 months
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From baseline to up to 3 months
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Change in the duration of functional independence using the Barthel ADL Index score
기간: From baseline to up to 4 years
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From baseline to up to 4 years
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공동 작업자 및 조사자
수사관
- 연구 의자: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .