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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Phoenix、Arizona、アメリカ、85013
- Foundation for Cancer Research and Education
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Phoenix、Arizona、アメリカ、85001-2071
- St. Joseph's Hospital and Medical Center
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California
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Concord、California、アメリカ、94524-4110
- Mount Diablo Regional Cancer Center
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Sacramento、California、アメリカ、95816
- Sutter Cancer Center
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San Francisco、California、アメリカ、94115
- UCSF Comprehensive Cancer Center
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Walnut Creek、California、アメリカ、94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
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Colorado
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Aurora、Colorado、アメリカ、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、アメリカ、06520-8040
- Yale Comprehensive Cancer Center
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Florida
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Gainesville、Florida、アメリカ、32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Illinois
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Chicago、Illinois、アメリカ、60612
- University of Illinois Medical Center
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Iowa
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Davenport、Iowa、アメリカ、52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City、Kansas、アメリカ、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、アメリカ、21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Michigan
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Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit、Michigan、アメリカ、48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New Jersey
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Edison、New Jersey、アメリカ、08818
- John F. Kennedy Medical Center
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New York
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Syracuse、New York、アメリカ、13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte、North Carolina、アメリカ、28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte、North Carolina、アメリカ、28232-2861
- Carolina Neurosurgery and Spine Associates
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Durham、North Carolina、アメリカ、27710
- Duke Comprehensive Cancer Center
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Durham、North Carolina、アメリカ、27705
- American College of Surgeons Oncology Group
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Winston-Salem、North Carolina、アメリカ、27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
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Pittsburgh、Pennsylvania、アメリカ、15212-4772
- Allegheny General Hospital
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Pittsburgh、Pennsylvania、アメリカ、15215
- UPMC St. Margaret
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Pittsburgh、Pennsylvania、アメリカ、15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
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Tennessee
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Memphis、Tennessee、アメリカ、38104
- Methodist Cancer Center at Methodist University Hospital
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Utah
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American Fork、Utah、アメリカ、84003
- American Fork Hospital
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Virginia
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Charlottesville、Virginia、アメリカ、22908
- Cancer Center at the University of Virginia
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Richmond、Virginia、アメリカ、23298-0631
- Massey Cancer Center at Virginia Commonwealth University
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Wisconsin
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Madison、Wisconsin、アメリカ、53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee、Wisconsin、アメリカ、53226
- Medical College of Wisconsin Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Overall survival (OS)
時間枠：Up to 6 months
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Up to 6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Time to CNS failure
時間枠：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
時間枠：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
時間枠：From baseline to up to 4 years
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From baseline to up to 4 years
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協力者と研究者
捜査官
- スタディチェア：Anthony Asher, MD, FACS、Carolina Neurosurgery and Spine Associates
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。