This phase II trial studies how well stereotactic radiosurgery works in treating patients with cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02886572.
PRIMARY OBJECTIVES:
I. Assess the impact of using linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery on the survival of patients with four or more brain metastases.
SECONDARY OBJECTIVES:
I. Describe the time to local brain recurrence.
II. Describe the time to distant brain recurrence.
III. Describe the time to death due to neurologic causes.
IV. Describe the prevalence of significant adverse events.
TERTIARY OBJECTIVES:
I. Describe changes over time in neurocognition.
II. Describe changes over time in quality of life.
III. Quantify treatment set-up and dosimetric data for this treatment technique.
IV. Describe the rate of salvage therapy.
V. Describe prevalence of radionecrosis at the stereotactic radiosurgery (SRS) site.
VI. Describe length and intensity of steroid usage post-SRS.
OUTLINE:
Patients undergo stereotactic radiosurgery over 30-90 minutes for 1-5 days.
After completion of study treatment, patients are followed up every 3 months for 12 months, and then every 6 months for the following 12 months.
Lead OrganizationDuke University Medical Center
Principal InvestigatorGrace Jewel Kim
