NCT05222620 · Mayo Clinic
SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
What this study is about
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.
View original scientific 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.
Interventions
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Stereotactic Radiosurgery
Undergo single fraction SRS
RADIATION
Stereotactic Radiosurgery
Undergo fractionated SRS
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
Primary outcome measures
Time to local failure or symptomatic radiation brain necrosis of large brain metastasis
Time frame: Up 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Jacksonville, Florida
- Albert Lea, Minnesota
- Mankato, Minnesota
- Rochester, Minnesota
- Eau Claire, Wisconsin
- La Crosse, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations