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Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
Sponsor: Medical University of South Carolina
Summary
This is a randomized, phase II trial comparing staged stereotactic radiosurgery (SSRS) versus fractionated stereotactic radiotherapy (FSRT) in patients with large brain metastases (≥2 cm and ≤5 cm). The study aims to evaluate efficacy, safety, and tumor response between these two standard-of-care radiation approaches.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2026-02-03
Completion Date
2030-02-03
Last Updated
2026-02-05
Healthy Volunteers
No
Interventions
Staged Stereotactic Radiosurgery (SSRS)
The large brain metastasis (or metastases) will be treated to a dose of 24-30 Gy in two fractions. Interval between the two fractions will be 30 days (+/- 10 days). Individual dosing for each fraction will be determined by the treating radiation oncologist, but total dose must equal 24-30 Gy.
Fractionated Stereotactic Radiotherapy (FSRT)
Fractionation will be 27 Gy in 3 daily fractions. The 3 daily fractions must be completed over a period of 3-5 days.
Locations (1)
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States