Dose Escalation Trial of Fractionated Stereotactic Radiosurgery for Brain Metastasis Greater Than 3cm
I. 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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
United States: Food and Drug Administration
|Emory University||Atlanta, Georgia 30322|