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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
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Arizona
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Phoenix, Arizona, Forente stater, 85013
- Foundation for Cancer Research and Education
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Phoenix, Arizona, Forente stater, 85001-2071
- St. Joseph's Hospital and Medical Center
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California
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Concord, California, Forente stater, 94524-4110
- Mount Diablo Regional Cancer Center
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Sacramento, California, Forente stater, 95816
- Sutter Cancer Center
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San Francisco, California, Forente stater, 94115
- UCSF Comprehensive Cancer Center
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Walnut Creek, California, Forente stater, 94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 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, Forente stater, 06520-8040
- Yale Comprehensive Cancer Center
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Florida
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Gainesville, Florida, Forente stater, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois Medical Center
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Iowa
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Davenport, Iowa, Forente stater, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
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Kansas
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Kansas City, Kansas, Forente stater, 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, Forente stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
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Michigan
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Detroit, Michigan, Forente stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Forente stater, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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Missouri
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Saint Louis, Missouri, Forente stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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New Jersey
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Edison, New Jersey, Forente stater, 08818
- John F. Kennedy Medical Center
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New York
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Charlotte, North Carolina, Forente stater, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Charlotte, North Carolina, Forente stater, 28232-2861
- Carolina Neurosurgery and Spine Associates
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Durham, North Carolina, Forente stater, 27705
- American College of Surgeons Oncology Group
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Winston-Salem, North Carolina, Forente stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Hershey, Pennsylvania, Forente stater, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, Forente stater, 15212-4772
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Forente stater, 15215
- UPMC St. Margaret
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Pittsburgh, Pennsylvania, Forente stater, 15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
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Tennessee
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Memphis, Tennessee, Forente stater, 38104
- Methodist Cancer Center at Methodist University Hospital
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Utah
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American Fork, Utah, Forente stater, 84003
- American Fork Hospital
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- Cancer Center at the University of Virginia
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Richmond, Virginia, Forente stater, 23298-0631
- Massey Cancer Center at Virginia Commonwealth University
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall survival (OS)
Tidsramme: Up to 6 months
|
Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to CNS failure
Tidsramme: Up to 4 years
|
Up to 4 years
|
|
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Tidsramme: 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
Tidsramme: From baseline to up to 4 years
|
From baseline to up to 4 years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACOSOG-Z0300
- CDR0000069183 (Annen identifikator: NCI Physician Data Query)
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