NCT05222620 SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
| NCT ID | NCT05222620 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Metastatic Malignant Neoplasm in the Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-03-14 |
| Primary Completion | 2027-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2022-03-14 with a primary completion date of 2027-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Paul D. Brown, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT05222620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Malignant Neoplasm in the Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05222620 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05222620 currently recruiting?
Yes, NCT05222620 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT05222620 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jacksonville, United States, Albert Lea, United States, Mankato, United States and 3 additional locations.
Who is sponsoring the NCT05222620 clinical trial?
NCT05222620 is sponsored by Mayo Clinic. The principal investigator is Paul D. Brown, MD at Mayo Clinic in Rochester. The trial plans to enroll 90 participants.