SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial

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

• Age >= 18 years old
• Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)
• Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible
• Size of brain metastases
• At least one intact metastasis (not previously treated with radiosurgery) must measure >= 2.0 cm and =< 4.0 cm in maximal extent on the contrasted pre-treatment magnetic resonance imaging (MRI) brain scan obtained =< 28 days prior to registration
• If the largest lesion measures >= 2.0 to =< 4.0 cm in maximal extent the patient will be randomized
• Able to undergo contrast enhanced MRI brain
• Negative urine or serum pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only
• Patient is willing and able to provide written informed consent or have a legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant provide consent.
• Karnofsky performance status (KPS) >= 50
• Eastern Cooperative Oncology Group (ECOG) performance score of (PS) >= 2
• Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations
• Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol

You cannot join if

• Any patient who has received previous whole brain radiation
• Any brain metastasis that is located in the brainstem measuring >= 2.0 cm in maximal extent
• Any patient with definitive evidence of leptomeningeal metastasis (LMD)
• NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (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, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
• Any patient with an intact brain metastasis measuring > 4.0 cm

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

• Questionnaire Administration (Other): Ancillary studies
• Stereotactic Radiosurgery (Radiation): Undergo single fraction SRS
• Stereotactic Radiosurgery (Radiation): Undergo fractionated SRS
• Magnetic Resonance Imaging (Procedure): Undergo MRI

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
• questionnaires: Part of the study plan

Main goals

• Time to local failure or symptomatic radiation brain necrosis of large brain metastasis (Up to 5 years)

Other goals

• Overall survival (OS)
• Incidence of adverse events
• Rates of radiation necrosis
• Central nervous system (CNS) failure patterns (Fractionation)
• Time to neurologic death
• Quality of life (QOL)
• CNS failure patterns (Gamma Knife)
• Per lesion analysis between treatment arms: time to local failure
• Per lesion analysis between treatment arms: time to necrosis
• Per lesion analysis between treatment arms: endpoint CTF

Planned enrollment: 90 (estimated).

• Mayo Clinic in Arizona, Scottsdale, Arizona
• Mayo Clinic in Florida, Jacksonville, Florida
• Mayo Clinic Health Systems-Mankato, Mankato, Minnesota
• Mayo Clinic in Rochester, Rochester, Minnesota
• Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin
• Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin

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

• ClinicalTrials.gov NCT05222620

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