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
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Anthony Asher, MD, FACS
Study Chair
Carolina Neurosurgery and Spine Associates
United States: Federal Government
CDR0000069183
NCT00030628
December 2001
Name | Location |
---|---|
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 |