Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
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.
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients With One to Three Cerebral Metastases|
- Neurocognitive progression [ Time Frame: 3 months post radiosurgery ] [ Designated as safety issue: No ]
- Time to CNS failure [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Quality of life, assessed by FACT-BR questionnaire, physician assessed neurological signs and symptoms, and treatment-related adverse events [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Neurocognitive status [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients undergo stereotactic radiosurgery (SRS)
|Radiation: stereotactic radiosurgery|
Experimental: 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.
Radiation: radiation therapy
Patients undergo radiation therapy 5 days a week for 2.5 weeksRadiation: stereotactic radiosurgery
- 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 238 patients will be accrued for this protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377156
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|Study Chair:||Paul D. Brown, MD||Mayo Clinic|