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

RecruitingPhase 2

Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

About the study

This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.

What is being tested

Sponsor: Mayo Clinic · Participants: 90 · Started: Mar 14, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05222620

Locations in the U.S.

ArizonaMayo Clinic in Arizona, Scottsdale
FloridaMayo Clinic in Florida, Jacksonville
MinnesotaMayo Clinic Health System in Albert Lea, Albert Lea (Not yet recruiting)
Mayo Clinic Health Systems-Mankato, Mankato
Mayo Clinic in Rochester, Rochester
WisconsinMayo Clinic Health System-Eau Claire Clinic, Eau Claire
Mayo Clinic Health System-Franciscan Healthcare, La Crosse

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.