BIGSHOT Trial: Radiation for Large Brain Metastases
This study, called BIGSHOT, is for people with large brain metastases (cancer that has spread to the brain, between 2 cm and 5 cm in size). It compares two standard radiation treatments: Staged Stereotactic Radiosurgery (SSRS) and Fractionated Stereotactic Radiotherapy (FSRT). SSRS involves 2 radiation treatments over about 30 days, while FSRT uses 3 daily treatments over 3-5 days. The study aims to see how well each treatment works, its safety, and how tumors respond. Researchers will follow participants for up to 36 months to measure outcomes like whether the tumor grows, if more treatment is needed, or if radiation causes damage. You may be able to join if you are 18 or older and have a good performance status (Karnofsky Performance Status of 60 or higher). The study plans to enroll 54 participants, but its current status is unclear.
- Study design
- This is a randomized Phase II study comparing two radiation treatments. It plans to enroll 54 participants.
- What's involved
- You would need to be willing to follow all study procedures and be available for the duration of the study. The specific number of visits or tests is not detailed.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for up to 36 months to assess treatment outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Charlotte Rivers, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
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What this trial measures
- 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.Up to 36 months.
For lesions \> 5 mm: Disease progression is defined as at least a 50% increase in the product of the two longest diameters of the target lesion, compared to the smallest product measured for that lesion. For lesions ≤ 5mm on the baseline scan, disease progression is defined as at least a 100% increase in the product of the two longest diameters of the target lesion, compared to the smallest product measured for the same lesion. * Radiation necrosis is defined by: pathologic diagnosis after resection or biopsy; OR initiation of steroids, and follow up MRI scan shows decrease in edema and stability of contrast of enhancing lesion that was concerning for radiation necrosis. * Radiation necrosis is NOT counted as disease progression. * Additional interventions include surgical resection, LITT (laser interstitial thermal therapy), or re-irradiation to the target lesion.