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NCT05222620 · ClinicalTrials.gov registry record · Phase 2
SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
A Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 7
- Study locations
NCT05222620: Recruiting Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by Mayo Clinic.
NCT05222620 is a Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 69 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (67% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05222620, a Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- OTHER Questionnaire Administration
- RADIATION Stereotactic Radiosurgery
Study Locations (7)
Minnesota
- Mayo Clinic Health System in Albert Lea - Albert Lea
- Mayo Clinic Health Systems-Mankato - Mankato
- Mayo Clinic in Rochester - Rochester
Wisconsin
- Mayo Clinic Health System-Eau Claire Clinic - Eau Claire
- Mayo Clinic Health System-Franciscan Healthcare - La Crosse
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2022-03-14 |
| Est. Completion | 2028-02-15 |
| Phase | Phase 2 |
What NCT05222620 shows while recruiting
NCT05222620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (67% lower).
The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT05222620 lists 7 locations in 4 states (Minnesota, Wisconsin, Arizona).
Frequently Asked Questions
What is clinical trial NCT05222620 about?
NCT05222620 is a clinical study titled "SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial". 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 focuse...
What is the current status of trial NCT05222620?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2022-03-14. Estimated completion is 2028-02-15.
What conditions does trial NCT05222620 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain.
What interventions are being tested in trial NCT05222620?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Questionnaire Administration (OTHER), Stereotactic Radiosurgery (RADIATION).
Who is sponsoring clinical trial NCT05222620?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05222620 being conducted?
This trial has 7 study locations across Arizona, Florida, Minnesota, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05222620's enrollment target sits among peer trials
69 38th of 92 higher than 55 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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