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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
-
-
Arizona
-
Phoenix, Arizona, Förenta staterna, 85013
- Foundation for Cancer Research and Education
-
Phoenix, Arizona, Förenta staterna, 85001-2071
- St. Joseph's Hospital and Medical Center
-
-
California
-
Concord, California, Förenta staterna, 94524-4110
- Mount Diablo Regional Cancer Center
-
Sacramento, California, Förenta staterna, 95816
- Sutter Cancer Center
-
San Francisco, California, Förenta staterna, 94115
- UCSF Comprehensive Cancer Center
-
Walnut Creek, California, Förenta staterna, 94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
-
-
Colorado
-
Aurora, Colorado, Förenta staterna, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
-
-
Connecticut
-
New Haven, Connecticut, Förenta staterna, 06520-8040
- Yale Comprehensive Cancer Center
-
-
Florida
-
Gainesville, Florida, Förenta staterna, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- University of Illinois Medical Center
-
-
Iowa
-
Davenport, Iowa, Förenta staterna, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
-
-
Kansas
-
Kansas City, Kansas, Förenta staterna, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital
-
-
Michigan
-
Detroit, Michigan, Förenta staterna, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, Förenta staterna, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
-
-
Missouri
-
Saint Louis, Missouri, Förenta staterna, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
-
-
New Jersey
-
Edison, New Jersey, Förenta staterna, 08818
- John F. Kennedy Medical Center
-
-
New York
-
Syracuse, New York, Förenta staterna, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Charlotte, North Carolina, Förenta staterna, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, Förenta staterna, 28232-2861
- Carolina Neurosurgery and Spine Associates
-
Durham, North Carolina, Förenta staterna, 27710
- Duke Comprehensive Cancer Center
-
Durham, North Carolina, Förenta staterna, 27705
- American College of Surgeons Oncology Group
-
Winston-Salem, North Carolina, Förenta staterna, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Taussig Cancer Center
-
-
Pennsylvania
-
Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh Medical Center
-
Pittsburgh, Pennsylvania, Förenta staterna, 15212-4772
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15215
- UPMC St. Margaret
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
-
-
Tennessee
-
Memphis, Tennessee, Förenta staterna, 38104
- Methodist Cancer Center at Methodist University Hospital
-
-
Utah
-
American Fork, Utah, Förenta staterna, 84003
- American Fork Hospital
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22908
- Cancer Center at the University of Virginia
-
Richmond, Virginia, Förenta staterna, 23298-0631
- Massey Cancer Center at Virginia Commonwealth University
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Overall survival (OS)
Tidsram: Up to 6 months
|
Up to 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Time to CNS failure
Tidsram: Up to 4 years
|
Up to 4 years
|
|
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Tidsram: 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
Tidsram: From baseline to up to 4 years
|
From baseline to up to 4 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ACOSOG-Z0300
- CDR0000069183 (Annan identifierare: NCI Physician Data Query)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .