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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85013
- Foundation for Cancer Research and Education
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Phoenix, Arizona, Stany Zjednoczone, 85001-2071
- St. Joseph's Hospital and Medical Center
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California
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Concord, California, Stany Zjednoczone, 94524-4110
- Mount Diablo Regional Cancer Center
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Sacramento, California, Stany Zjednoczone, 95816
- Sutter Cancer Center
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San Francisco, California, Stany Zjednoczone, 94115
- UCSF Comprehensive Cancer Center
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Walnut Creek, California, Stany Zjednoczone, 94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 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, Stany Zjednoczone, 06520-8040
- Yale Comprehensive Cancer Center
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois Medical Center
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Iowa
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Davenport, Iowa, Stany Zjednoczone, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, Stany Zjednoczone, 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, Stany Zjednoczone, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Brigham and Women's Hospital
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Stany Zjednoczone, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Missouri
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Saint Louis, Missouri, Stany Zjednoczone, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New Jersey
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Edison, New Jersey, Stany Zjednoczone, 08818
- John F. Kennedy Medical Center
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New York
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Syracuse, New York, Stany Zjednoczone, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Stany Zjednoczone, 28232-2861
- Carolina Neurosurgery and Spine Associates
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke Comprehensive Cancer Center
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Durham, North Carolina, Stany Zjednoczone, 27705
- American College of Surgeons Oncology Group
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Winston-Salem, North Carolina, Stany Zjednoczone, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212-4772
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15215
- UPMC St. Margaret
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
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Tennessee
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Memphis, Tennessee, Stany Zjednoczone, 38104
- Methodist Cancer Center at Methodist University Hospital
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Utah
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American Fork, Utah, Stany Zjednoczone, 84003
- American Fork Hospital
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Virginia
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Charlottesville, Virginia, Stany Zjednoczone, 22908
- Cancer Center at the University of Virginia
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Richmond, Virginia, Stany Zjednoczone, 23298-0631
- Massey Cancer Center at Virginia Commonwealth University
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Wisconsin
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Madison, Wisconsin, Stany Zjednoczone, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College of Wisconsin Cancer Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
|
Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Overall survival (OS)
Ramy czasowe: Up to 6 months
|
Up to 6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Time to CNS failure
Ramy czasowe: Up to 4 years
|
Up to 4 years
|
|
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Ramy czasowe: From baseline to up to 3 months
|
From baseline to up to 3 months
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Change in the duration of functional independence using the Barthel ADL Index score
Ramy czasowe: From baseline to up to 4 years
|
From baseline to up to 4 years
|
Współpracownicy i badacze
Współpracownicy
Śledczy
- Krzesło do nauki: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- ACOSOG-Z0300
- CDR0000069183 (Inny identyfikator: NCI Physician Data Query)
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