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

StatusRecruiting
PhasePhase 2
Started2022-03-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Feb 15, 2027 → Aug 1, 2027
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2027-02-15 → 2027-08-01
Completion moved earlier: 2028-02-15 → 2027-08-01
2026-04-09
Study Status, Study Description, Arms and Interventions v14
Study description+52 characters
[...] d during follow up. ARM B: Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days. Patients also undergo MRI at screening and during follow u [...]
2026-03-25
Study Status, Study Design v13
Enrollment target69→90
2026-01-05
Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 7 sites
2025-08-07
Study Status, Oversight, Eligibility v11
Eligibility criteria+152 characters
[...] gistration, 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 Cooperativ [...]
Show 10 earlier versions
2025-02-13
Study Identification, Study Status, Contacts/Locations v10
Study sitesdetails revised at 7 of 7 sites
Study titlerevised
SRS Compared withWith FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
2024-10-23
Study Identification, Study Status, Oversight, Contacts/Locations v9
Study sites3→7
Study titlerevised
SRS Compared Withwith FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
2024-03-20
Study Status, Study Description, Conditions, Arms and Interventions v8
InterventionsQuestionnaire Administration (Other), Stereotactic Radiosurgery (Radiation), Stereotactic Radiosurgery (Radiation)→Magnetic Resonance Imaging (Procedure), Questionnaire Administration (Other), Stereotactic Radiosurgery (Radiation), Stereotactic…
Study description+151 characters
[...] o 1 of 2 arms. ARM A: Patients undergo single fraction SRS. Patients also undergo magnetic resonance imaging (MRI) at screening and during follow up. ARM B: Patients undergo fractionated SRS. Patients also undergo MRI at screening and during follow up. After completion of study treatment, patients are followed u [...]
2023-10-04
Study Status, Contacts/Locations v7
Study sites1→3
2023-09-25
Study Identification, Study Status, Outcome Measures, Contacts/Locations, References v6
Secondary endpoints10 entries, revised
Per lesion analysis between treatment arms: time to local failure Per lesion analysis between treatment arms: time to necrosis Per lesion analysis between treatment arms: endpoint CTF
Study title-72 characters
Single Fraction Stereotactic RadiosurgerySRS Compared With Fractionated Stereotactic RadiosurgeryFSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
2023-04-24
Study Status v5
Re-verified, no change to tracked fields
2023-01-05
Study Identification, Study Status, Sponsor/Collaborators v4
Collaborators-31 characters
National Cancer Institute (NCI)
2022-03-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04-02→confirmed 2022-03-14
Study sitesdetails revised at 1 of 1 site
2022-02-18
Study Status v2
Start date2022-02-02→2022-04-02
2022-02-02
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2022-01-24
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
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 Details
NCT Number NCT05222620
Lead Sponsor Mayo Clinic
Conditions Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
Enrollment 90 participants
Start Date 2022-03-14
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-10-01