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RECRUITING
NCT07227610
PHASE2

Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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

2026-02-06

Completion Date

2032-01-11

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

RADIATION

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.

RADIATION

Fractionated Stereotactic Radiotherapy (FSRT)

Fractionation will be 27 Gy in 3 daily fractions or 25-30 Gy in 5 fx. If using 3 daily fractions, they must be completed over a period of 3-5 days. If using 5 daily fractions, they must be completed over a period of 5-10 days. Treatment with 3 or 5 daily fractions is at the discretion of the treating physician.

Locations (1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States