Status:
RECRUITING
SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
Lead Sponsor:
Mayo Clinic
Conditions:
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (m...
Detailed Description
PRIMARY OBJECTIVE: I. To ascertain if the composite endpoint of cumulative treatment failure, defined by time to either local failure or symptomatic radiation brain necrosis of the largest brain meta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2028
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05222620
Start Date
March 14 2022
End Date
February 15 2028
Last Update
January 7 2026
Active Locations (7)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
3
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
4
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56001