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RATIONALE: Stereotactic radiation therapy can send x-rays directly to the tumor and cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether stereotactic radiation therapy is more effective with or without whole-brain radiation therapy in treating patients with brain metastases.
PURPOSE: This randomized phase III trial is studying stereotactic radiation therapy and whole-brain radiation therapy to see how well they work compared with stereotactic radiation therapy alone in treating patients with brain metastases.
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy.
- Compare time to CNS (brain) failure in patients treated with these regimens.
- Compare quality of life, duration of functional independence, and long-term neurocognitive status of patients treated with these regimens.
- Compare post-treatment toxicity in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (18 to 59 vs 60 and over), extracranial disease (controlled for ≤ 3 months vs controlled for > 3 months), and number of brain metastases (1 vs 2 vs 3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo stereotactic radiosurgery (SRS).
- Arm II: Patients undergo SRS as in arm I. Within 14 days, patients then undergo whole-brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life, functional independence, and neurocognitive status are assessed at baseline, at the beginning of each treatment, at weeks 6 and 12, and then at 6, 9, 12, 16, 24 , 36, 48, and 60 months.
PROJECTED ACCRUAL: A total of 528 patients will be accrued for this protocol.
Allocation: Randomized, Primary Purpose: Treatment
radiation therapy, stereotactic radiosurgery
Providence Cancer Center at Providence Hospital
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:42:29-0400
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