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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Overall survival (OS)
Time frame: Up to 6 months
Time to CNS failure
Time frame: Up to 4 years
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Time frame: From baseline to up to 3 months
Change in the duration of functional independence using the Barthel ADL Index score
Time frame: From baseline to up to 4 years
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480
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Mount Diablo Regional Cancer Center
Concord, California, United States
Sutter Cancer Center
Sacramento, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
John Muir Comprehensive Cancer Center at John Muir Medical Center
Walnut Creek, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States
...and 27 more locations