NCT00377156.

Trial name or title	Stereotactic Radiation Therapy With or Without Whole‐Brain Radiation Therapy in Treating Patients With Brain Metastases
Methods	Randomized Controlled Study Multi centre
Participants	Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Diagnosis of cerebral metastases meeting the following criteria: One to three presumed brain metastases Metastases must be from a histologically confirmed extracerebral site (e.g., lung, breast, prostate) Histological confirmation may have been from the primary tumour site, from another metastatic site (e.g., osseous metastasis, adrenal metastasis), or from the metastatic brain lesion(s) Each lesion must measure less than 3.0 cm by contrast MRI of the brain performed within the past 21 days Lesions must not be within 5 mm of the optic chiasm or within the brainstem Eligibility for treatment with gamma knife or linear accelerator‐based radiosurgery confirmed by a radiation oncologist No primary germ cell tumour, small cell carcinoma, or lymphoma No leptomeningeal metastases Hormone receptor status not specified PATIENT CHARACTERISTICS: Male or female Menopausal status not specified ECOG performance status 0‐2 Not pregnant Negative pregnancy test Fertile patients must use effective contraception Male patients must continue to use contraception for 3 months after the completion of radiotherapy No pacemaker or other MRI‐incompatible metal in the body No known allergy to gadolinium PRIOR CONCURRENT THERAPY: More than 7 days since prior and no concurrent chemotherapy No prior cranial radiotherapy No prior resection of cerebral metastases Concurrent hormonal agents, steroids, and/or anticonvulsants allowed
Interventions	Active Comparator: Arm I Patients undergo stereotactic radiosurgery (SRS) 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.
Outcomes	Primary Outcome Measures: Survival as measured by stratified logrank test and Cox proportional hazards models at 6 months [ Designated as safety issue: No ] Secondary Outcome Measures: Time to CNS failure [ Designated as safety issue: No ] Quality of life, in terms of brain sub scale and physical and emotional functioning, as measured by FACT‐BR questionnaire, physician‐assessed neurological signs and symptoms, and treatment‐related adverse events at 3 months post treatment [ Designated as safety issue: Yes ] Functional independence as measured by Barthel Activities of Daily Living Index and ECOG performance status [ Designated as safety issue: No ] Duration of functional independence [ Designated as safety issue: No ] Neurocognitive status as measured by objective assessment of changes in cognitive signs and symptoms and physician‐assessed toxicities at 3 months post treatment [ Designated as safety issue: Yes ]
Starting date	Jul 2006
Contact information	Study Chair:Paul D. Brown, MD Mayo Clinic Investigator:Kurt A. Jaeckle, MD Mayo Clinic Investigator:Richard L. Deming, MD Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center ‐ Des Moines Investigator:Elana Farace, PhD Milton S. Hershey Medical Center Investigator:Bruce Pollock, MD Mayo Clinic Study Chair:Anthony Asher, MD, FACS Carolina Neurosurgery and Spine Associates Investigator:Fred G. Barker, MD Massachusetts General Hospital Study Chair:Larry Kleinberg, MD Sidney Kimmel Comprehensive Cancer Center
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