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

NCT07227610 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-05

No results posted yet for this study

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.

Conditions

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. The 3 daily fractions must be completed over a period of 3-5 days.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Charlotte Rivers, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-03
Primary Completion
2029-02-03
Completion
2030-02-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227610 on ClinicalTrials.gov