RecruitingPhase 2NCT07227610

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

Sponsor

Medical University of South Carolina

Enrollment

54 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Conditions

Brain Metastases Cancer (With CNS Involvement)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called BIGSHOT) compares two radiation techniques — giving radiation in a few larger doses (hypofractionated SRS) — for treating larger brain metastases (cancer that has spread to the brain) that are between 2 and 5 centimeters in size. **You may be eligible if...** - You are 18 or older with confirmed brain metastases between 2 and 5 cm in size - You have a known or active primary cancer elsewhere in the body (diagnosed in the past 3 years) - Your general health is good enough to tolerate stereotactic radiosurgery (SRS) - Your brain symptoms are stable and do not require immediate surgery - Up to 10 additional smaller brain metastases are allowed **You may NOT be eligible if...** - Your brain tumors are smaller than 2 cm or larger than 5 cm - Your tumors are within 5 mm of the optic nerves or optic chiasm - You are unable to tolerate SRS or are neurologically unstable - You are pregnant (a negative pregnancy test is required) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStaged 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.

RADIATIONFractionated 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.