Actively Recruiting
SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
Led by Mayo Clinic · Updated on 2026-04-13
90
Participants Needed
7
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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
Official Title
SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3B 18 years old
- Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)
- At least one intact metastasis not previously treated with radiosurgery measuring �3B 2.0 cm and �3C 4.0 cm on contrast MRI obtained within 28 days prior to registration
- Able to undergo contrast enhanced MRI brain
- Negative urine or serum pregnancy test within 7 days prior to registration for women of childbearing potential
- Willing and able to provide written informed consent or have a legally Authorized Representative provide consent
- Karnofsky performance status (KPS) �3B= 50
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) �3B= 2
- Past radiosurgery or resection allowed if no progression in those locations
- Repeat radiosurgery to the same lesion is not allowed
You will not qualify if you...
- Any patient who has received previous whole brain radiation
- Any brain metastasis located in the brainstem measuring �3B 2.0 cm
- Definitive evidence of leptomeningeal metastasis (LMD) by clinical diagnosis, CSF cytology, or radiologic evidence
- Intact brain metastasis measuring greater than 4.0 cm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
Not Yet Recruiting
4
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56001
Actively Recruiting
5
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
7
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here