Recruiting

Phase 2

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

Sponsor:

Mayo Clinic

Code:

NCT05222620

Conditions

Metastatic Malignant Neoplasm in the Brain

Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaire Administration

Stereotactic Radiosurgery

Magnetic Resonance Imaging

Study Details

Brief summary:

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.

Conditions

Metastatic Malignant Neoplasm in the Brain

Metastatic Malignant Solid Neoplasm

Study ID

NCT05222620

Start date

Mar 14, 2022

Status verified date

Apr, 2026

Completion date

Feb 15, 2028

Anticipated

Primary completion date

Feb 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Arm A (single fraction SRS)

Patients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.

other: Arm B (fractionated SRS)

Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days.. Patients also undergo MRI at screening and during follow up.

Interventions

Questionnaire Administration

Ancillary studies

Stereotactic Radiosurgery

Undergo single fraction SRS

Stereotactic Radiosurgery

Undergo fractionated SRS

Magnetic Resonance Imaging

Undergo MRI

Primary outcome measure

Time to local failure or symptomatic radiation brain necrosis of large brain metastasis [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Sujay A. Vora, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Jennifer L. Peterson, MD

Mayo Clinic Health Systems-Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Lori Rhodes

507-284-0063 Rhodes.Lori@mayo.edu

Principal Investigator:

Jason T. Hayes, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Paul D. Brown, M.D.

Mayo Clinic Health System-Eau Claire Clinic

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Lori Rhodes

507-284-0063 Rhodes.Lori@mayo.edu

Principal Investigator:

Now Bahar Alam, MD

Mayo Clinic Health System-Franciscan Healthcare

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Lori Rhodes

507-284-0063 Rhodes.Lori@mayo.edu

Principal Investigator:

Abigail L. Stockham, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-13.