SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)
3 other identifiers
interventional
90
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2028
April 13, 2026
April 1, 2026
4.9 years
January 11, 2022
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to local failure or symptomatic radiation brain necrosis of large brain metastasis
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).
Up to 5 years
Secondary Outcomes (10)
Overall survival (OS)
From study entry to death from any cause, assessed up to 5 years
Incidence of adverse events
Up to 2 years post radiation therapy
Rates of radiation necrosis
Up to 5 years
Central nervous system (CNS) failure patterns (Fractionation)
Up to 5 years
Time to neurologic death
Up to 5 years
- +5 more secondary outcomes
Study Arms (2)
Arm A (single fraction SRS)
OTHERPatients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.
Arm B (fractionated SRS)
OTHERPatients 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
Ancillary studies
Undergo single fraction SRS
Undergo MRI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Any patient with an intact brain metastasis measuring \> 4.0 cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (7)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul D. Brown, MD
Mayo Clinic in Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2022
First Posted
February 3, 2022
Study Start
March 14, 2022
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
February 15, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04