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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Presbyterian Hospital
Albuquerque, New Mexico, United States
MD Anderson in The Woodlands
Conroe, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
Incidence of lesion failure based on imagining assessments for each lesion
Time frame: Up to 1 year
Rates of local control
Time frame: Up to 1 year
Intracranial progression free survival (PFS)
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial PFS.
Time frame: From enrollment to either the first observation of progression disease in the brain or death due to any cause, assessed up to 1 year
Overall survival (OS)
Will be summarized using the Kaplan-Meier method and the 50th percentile of the Kaplan-Meier distribution will determine the median intracranial OS.
Time frame: Up to 1 year
Cost data
Will be summarized using descriptive statistics such as mean, median, standard deviation, and range. Comparisons in cost between treatment modalities will be evaluated using a paired t-test where each patient will serve as his or her own control to determine if the cost of frameless fractionated stereotactic radiation therapy (FFSRT) is comparable to standard treatment.
Time frame: Up to 1 year
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