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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• The patient or a legally authorized representative must be able and willing to provide study-specific informed consent prior to study entry.
• Patient must be willing to comply with all study procedures and available for the duration of the study
• Male or female, aged ≥ 18 years
• Karnofsky Performance Status (KPS) ≥ 60 within 7 days prior to registration
• Radiographic confirmation of brain metastasis measuring ≥2 cm and ≤ 5 cm in maximum diameter
• 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.
• 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
• All tumors must be ≥ 5mm from the optic chiasm and optic nerves.
• Known active or history of invasive non-CNS primary cancer based on documented pathologic diagnosis within the past 3 years
• Patient is able to medically tolerate SRS
• Patient is neurologically stable (immediate surgery not necessary or not recommended)
• A negative urine or serum pregnancy test (in persons of childbearing potential) within 7 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
• Women who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy.

You cannot join if

• Prior cranial radiotherapy, including whole brain radiotherapy (WBRT), or SRS in the area of the large metastasis to be treated on study.
• 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.
• Inability to undergo MRI with contrast
• Planned administration of systemic therapy (chemotherapy or immunotherapy) within 3 days prior to, the day of, or 3 days after completion of SRS.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• 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 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.

Randomized · Parallel · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• MRI: Part of the study plan
• surgery: Part of the study plan
• radiation: Part of the study plan

Main goals

• 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.)

Other goals

• Compare the safety profile by radiation toxicity

Planned enrollment: 54 (estimated).

• Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07227610

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 17, 2026. Public record; not medical advice.