Actively Recruiting
Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
Led by Medical University of South Carolina · Updated on 2026-02-05
54
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent before study entry
- Willing to comply with all study procedures and available for the duration of the study
- Male or female aged 18 years or older
- Karnofsky Performance Status of 60 or higher within 7 days before registration
- Radiographic confirmation of brain metastasis measuring between 2 cm and 5 cm in maximum diameter
- Multiple metastases allowed; up to 10 additional smaller metastases under 2 cm allowed and treated with single fraction SRS
- If more than one large metastasis (2-5 cm), up to two can be treated on study
- All tumors must be at least 5 mm from the optic chiasm and optic nerves
- Known active or history of invasive non-CNS primary cancer diagnosed within the past 3 years
- Medically able to tolerate stereotactic radiosurgery
- Neurologically stable without immediate need for surgery
- Negative urine or serum pregnancy test within 7 days before registration for persons of childbearing potential
- Sexually active participants must agree to use medically acceptable contraception during treatment
You will not qualify if you...
- Prior cranial radiotherapy, including whole brain radiotherapy or SRS, to the area of the large metastasis to be treated
- Evidence of leptomeningeal disease based on clinical diagnosis or imaging
- Inability to undergo MRI with contrast
- Planned chemotherapy or immunotherapy within 3 days before, the day of, or 3 days after completing stereotactic radiosurgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
HCC Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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