This phase II trial studies the safety and efficacy of frameless fractionated stereotactic radiation therapy for brain metastases. Frameless fractionated stereotactic radiosurgery is a specialized radiation therapy that delivers 3 to 5, high dose fractions of radiation directly to the brain lesions while sparing normal tissues.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02798029.
PRIMARY OBJECTIVES:
I. To assess the efficacy and safety of frameless fractionated stereotactic radiation therapy (FFSRT) on the treatment of solitary and oligometastatic brain metastases in the MD Anderson Houston Area Locations, MD Anderson Radiation Treatment Centers in New Mexico, MD Anderson affiliates and the main campus of MD Anderson, for patients unable or unwilling to undergo frame-based stereotactic radiosurgery (SRS).
SECONDARY OBJECTIVES:
I. To assess 6-month local control, intracranial progression-free survival and overall survival.
II. To collect data on charges and reimbursements of patients treated with FFSRT to compare those charges and reimbursements if the same patients had been treated with single-fraction, frame-based gamma knife SRS.
OUTLINE:
Patients undergo FFSRT daily over 30 minutes for 3-5 days.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorStephen G. Chun
