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Comparing Radiation Therapies for Brain Metastases (FRACTIONATE Trial)

This study, called the FRACTIONATE Trial, is comparing two types of radiation therapy for people whose cancer has spread to their brain. These are single fraction stereotactic radiosurgery (SRS), which is one large dose of radiation, and fractionated stereotactic radiosurgery (FSRS), which is radiation given in smaller doses over time. The goal is to see which method is better at controlling the tumors and causing fewer side effects. You may be able to join if you are at least 18 years old and have brain metastases (cancer spread to the brain) from another part of your body, with at least one tumor measuring between 2.0 cm and 4.0 cm that hasn't been treated with radiosurgery before. The study will track how long it takes for the treated tumor to grow again or for you to experience serious side effects from the radiation, for up to 5 years.

Study design
This is an interventional study comparing two radiation treatments. It plans to enroll 90 participants.
What's involved
You would undergo either single fraction SRS or fractionated SRS, and have Magnetic Resonance Imaging (MRI) scans. You would also complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to monitor for local failure or symptomatic radiation brain necrosis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05222620

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~90 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Questionnaire AdministrationStereotactic RadiosurgeryMagnetic Resonance Imaging

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to local failure or symptomatic radiation brain necrosis of large brain metastasis
Measured over Up to 5 years

Conditions

Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm

Explore related trials

Metastatic Malignant Neoplasm in the BrainSolid Neoplasm

Where it's being run

7 sites across 4 states
Minnesota3
Wisconsin2
Arizona1
Florida1

Study leadership

  • Paul D. Brown, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Time to local failure or symptomatic radiation brain necrosis of large brain metastasisUp to 5 years

    Will determine if the composite endpoint of time to local failure or symptomatic radiation brain necrosis of a large brain metastasis \[cumulative treatment failure (CTF)\] is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).