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

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07227610
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • Cancer (With CNS Involvement)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Staged Stereotactic Radiosurgery (SSRS) — RADIATION
    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) — RADIATION
    Fractionation will be 27 Gy in 3 daily fractions. The 3 daily fractions must be completed over a period of 3-5 days.

Study Details

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 Dates

Start date
Feb 3, 2026
Status verified
Feb 2026
Primary completion
Feb 3, 2029
Completion
Feb 3, 2030

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Staged Stereotactic Radiosurgery (SSRS)
    Patient will be scheduled for treatment with SSRS within one week of randomization. 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). MRI brain for planning purposes will be obtained either on the day of each treatment, or within 7 days prior to each treatment. Individual dosing for each fraction will be determined by the treating radiation oncologist, but total dose must equal 24-30 Gy. Any additional smaller metastases will be treated in a single fraction concurrently. Fixation for treatment will be either in a surgical headframe or mask.
  • Experimental: Fractionated Stereotactic Radiotherapy (FSRT)
    Patient will be scheduled for treatment with FSRT within one week of randomization. FSRT will be performed with mask fixation. Fractionation will be 27 Gy in 3 daily fractions. The 3 daily fractions must be completed over a period of 3-5 days. MRI for planning purposes must be completed within 7 days prior to delivery of first fraction. Any additional smaller metastases will be treated in a single fraction concurrently.

Primary Outcome Measure

Time to Composite unfavorable outcome (CUO) by (1) lack of local control (disease progression for any lesion treated on study); (2) the need for further intervention to the treated tumor; (3) radiation necrosis. [ Time Frame: Up to 36 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South Carolina Hollings Cancer CenterCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321

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By research site
Medical University of South Carolina Hollings Cancer Center· Charleston, SC

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