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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Spojené státy, 85013
- Foundation for Cancer Research and Education
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Phoenix, Arizona, Spojené státy, 85001-2071
- St. Joseph's Hospital and Medical Center
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California
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Concord, California, Spojené státy, 94524-4110
- Mount Diablo Regional Cancer Center
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Sacramento, California, Spojené státy, 95816
- Sutter Cancer center
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San Francisco, California, Spojené státy, 94115
- UCSF Comprehensive Cancer Center
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Walnut Creek, California, Spojené státy, 94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
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Colorado
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Aurora, Colorado, Spojené státy, 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, Spojené státy, 06520-8040
- Yale Comprehensive Cancer Center
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Florida
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Gainesville, Florida, Spojené státy, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Illinois
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Chicago, Illinois, Spojené státy, 60612
- University of Illinois Medical Center
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Iowa
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Davenport, Iowa, Spojené státy, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, Spojené státy, 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, Spojené státy, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Brigham and Women's Hospital
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Michigan
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Detroit, Michigan, Spojené státy, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Spojené státy, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Missouri
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Saint Louis, Missouri, Spojené státy, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New Jersey
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Edison, New Jersey, Spojené státy, 08818
- John F. Kennedy Medical Center
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New York
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Syracuse, New York, Spojené státy, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Spojené státy, 28232-2861
- Carolina Neurosurgery and Spine Associates
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Durham, North Carolina, Spojené státy, 27710
- Duke Comprehensive Cancer Center
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Durham, North Carolina, Spojené státy, 27705
- American College of Surgeons Oncology Group
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Winston-Salem, North Carolina, Spojené státy, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, Spojené státy, 15212-4772
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Spojené státy, 15215
- UPMC St. Margaret
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Pittsburgh, Pennsylvania, Spojené státy, 15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
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Tennessee
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Memphis, Tennessee, Spojené státy, 38104
- Methodist Cancer Center at Methodist University Hospital
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Utah
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American Fork, Utah, Spojené státy, 84003
- American Fork Hospital
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- Cancer Center at the University of Virginia
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Richmond, Virginia, Spojené státy, 23298-0631
- Massey Cancer Center at Virginia Commonwealth University
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Wisconsin
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Madison, Wisconsin, Spojené státy, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, Spojené státy, 53226
- Medical College of Wisconsin Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
|
|
Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Overall survival (OS)
Časové okno: Up to 6 months
|
Up to 6 months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Time to CNS failure
Časové okno: Up to 4 years
|
Up to 4 years
|
|
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Časové okno: From baseline to up to 3 months
|
From baseline to up to 3 months
|
|
Change in the duration of functional independence using the Barthel ADL Index score
Časové okno: From baseline to up to 4 years
|
From baseline to up to 4 years
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ACOSOG-Z0300
- CDR0000069183 (Jiný identifikátor: NCI Physician Data Query)
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