RecruitingBrain MetastasesCancer (With CNS Involvement)
Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Medical University of South Carolina
You may qualify if…
- ✓ 1. The patient or a legally authorized representative must be able and willing to provide study-specific informed consent prior to study entry.
- ✓ 2. Patient must be willing to comply with all study procedures and available for the duration of the study
- ✓ 3. Male or female, aged ≥ 18 years
- ✓ 4. Karnofsky Performance Status (KPS) ≥ 60 within 7 days prior to registration
- ✓ 5. Radiographic confirmation of brain metastasis measuring ≥2 cm and ≤ 5 cm in maximum diameter
- ✓ 1. Multiple metastases are allowed. Additional metastases will be treated with single fraction SRS as per standard of care. Up to 10 additional smaller metastases are allowed on protocol. All additional smaller metastases must be less than 2 cm.
- ✓ 2. If a patient has more than one large metastasis (measuring between 2 and 5 cm as above), up to two can be treated on study protocol
- ✓ 3. All tumors must be ≥ 5mm from the optic chiasm and optic nerves.
You may not qualify if…
- ✕ 1. Prior cranial radiotherapy, including whole brain radiotherapy (WBRT), or SRS in the area of the large metastasis to be treated on study.
- ✕ 2. Evidence of leptomeningeal disease (LMD) Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive CSF cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In such cases, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.
- ✕ 3. Inability to undergo MRI with contrast
- ✕ 4. Planned administration of systemic therapy (chemotherapy or immunotherapy) within 3 days prior to, the day of, or 3 days after completion of SRS.
Where it's recruiting
South Carolina
Charleston
Source: ClinicalTrials.gov · NCT07227610 · last updated 2026-02-05