Clinical Trials

Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Location:

Rochester, MN, Jacksonville, FL

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES: Primary - Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy. Secondary - 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 238 patients will be accrued for this protocol.

Last updated: 02/26/2013

NCT ID:

NCT00377156