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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Anthony Asher, MD, FACS
Carolina Neurosurgery and Spine Associates
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Cancer Center at the University of Virginia||Charlottesville, Virginia 22908|
|St. Joseph's Hospital and Medical Center||Phoenix, Arizona 85001-2071|
|John F. Kennedy Medical Center||Edison, New Jersey 08818|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Sutter Cancer Center||Sacramento, California 95816|
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|
|Foundation for Cancer Research and Education||Phoenix, Arizona 85013|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Massey Cancer Center at Virginia Commonwealth University||Richmond, Virginia 23298-0037|
|American Fork Hospital||American Fork, Utah 84003|
|Josephine Ford Cancer Center at Henry Ford Health System||Detroit, Michigan 48202|
|Shands Cancer Center at the University of Florida Health Science Center||Gainesville, Florida 32610-0296|
|University of Illinois Medical Center||Chicago, Illinois 60612|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Mount Diablo Regional Cancer Center||Concord, California 94524-4110|
|Genesis Regional Cancer Center at Genesis Medical Center||Davenport, Iowa 52803|
|UPMC St. Margaret||Pittsburgh, Pennsylvania 15215|
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|
|Carolina Neurosurgery and Spine Associates||Charlotte, North Carolina 28207-1830|
|John Muir Comprehensive Cancer Center at John Muir Medical Center||Walnut Creek, California 94598|
|University of Pittsburgh Medical Center - Shadyside Hospital||Pittsburgh, Pennsylvania 15213-2582|
|Methodist Cancer Center at Methodist University Hospital||Memphis, Tennessee 38104|