RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT05222620

Registry updated: 2026-10-01

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Description

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.

Interventions

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

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

Conditions

Metastatic Malignant Neoplasm in the Brain Metastatic Malignant Solid Neoplasm

Locations

Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Mayo Clinic in Florida — Jacksonville, Florida, United States
Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States
Mayo Clinic Health Systems-Mankato — Mankato, Minnesota, United States
Mayo Clinic in Rochester — Rochester, Minnesota, United States
Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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