This phase I trial studies the side effects and best dose of hypofractionated radiosurgery in treating patients with large brain metastasis. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving fractionated stereotactic radiosurgery may kill more tumor cells.
PRIMARY OBJECTIVE: To demonstrate the safety and feasibility of treating brain metastases or resection cavities greater than 3 cm with hypofractionated radiosurgery and to determine the maximum-tolerated radiation dose for hypofractionated radiosurgery (HR) delivered in 5 fractions, 2-3 fractions per week. OUTLINE: This is a dose-escalation study. Patients undergo hypofractionated stereotactic radiosurgery 2-3 times weekly (5 fractions total) for 2-3 weeks. After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Maximum Tolerated Dose (MTD) of Hypofractionated Radiosurgery Defined as the Highest Dose Level Where a Grade 3 or Greater With an Attribution Score of ≥ 3 Develops in ≤ 2 of 6 Patients in a Dose Group
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The rate of toxicities will be calculated with 95% confidence interval (CI).
Time frame: 4 months
Percentage of Participants With Neurologic Toxicity/Radiation Necrosis Possibly Due to Treatment, Graded According to the CTCAE Version 4.03 as Grade 2 or Greater.
Number
Time frame: Up to 2 years
Local Control; Lack of Progression of Disease in Resection Cavity as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria
Cumulative incidences of local brain progression will be calculated by Kaplan-Meier method with 95% CI.
Time frame: 24 months
Intercranial Progression Free Survival: Lack of Progression of Disease in Surrounding Brain as Defined by RECIST Criteria
Percentage of patients with distant brain progression at the defined time point, with each individual patient's time to progression calculated by Kaplan-Meier method with 95% CI.
Time frame: 12 months
Freedom From Failure/Progression Free Survival
Time frame: Up to 2 years
Overall Survival (OS): Death From Any Cause
The median of OS time with 95% CI will be calculated by Kaplan-Meier method.
Time frame: Up to 2 years
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Scores
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Percentage of Participants with a Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Z-Score of ≤ -1.
Time frame: Up to 4 months
Quality of Life (QOL) Outcomes: Using the Quality of Life Questionnaire for the Functional Assessment of Cancer Therapy-Brain (FACT-Br).
Patients completed the FACT-BR at baseline and in follow-up. Responses are summed at each encounter to create a score. Total assessments combine scores range from 0-200. The higher the score, the better the QOL. Change from baseline to 4-month follow-up was calculated. A notable change is defined 20 point or greater increase or decrease in total score from baseline to 4-month follow-up score.
Time frame: Up to 2 years