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Radiation Therapy

Stereotactic Radiosurgery for Brain Metastasis

Phase 2

Recruiting

Led By Paul D Brown

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.) including dural based metastases

Age >= 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial compares the effect of single-fraction vs. fractionated stereotactic radiosurgery for brain metastases.

Who is the study for?

This trial is for adults with cancer that has spread to the brain from another body part, like lung or breast. Participants must have at least one tumor in the brain between 2.0 and 4.0 cm not previously treated with radiosurgery, be able to undergo MRI scans, and have a certain level of physical function (KPS >= 50 or ECOG PS >= 2). Pregnant women and those who've had whole-brain radiation or specific large brainstem metastases are excluded.Check my eligibility

What is being tested?

The FRACTIONATE trial is comparing two types of stereotactic radiosurgery (SRS) for treating brain tumors: single fraction SRS delivers treatment in one session while fractionated SRS spreads it over multiple sessions. The goal is to see which method better controls the tumor growth and side effects.See study design

What are the potential side effects?

Potential side effects include localized hair loss, headaches, nausea, fatigue, swelling around the treatment area leading to increased intracranial pressure symptoms such as vision changes or seizures; rare risks involve hearing loss or cognitive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread to my brain from another part of my body.

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I am 18 years old or older.

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My daily activity is limited due to my health condition.

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I am able to live at home and care for most of my personal needs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to local failure or symptomatic radiation brain necrosis of large brain metastasis

Secondary outcome measures

CNS failure patterns (Gamma Knife)

Central nervous system (CNS) failure patterns (Fractionation)

Incidence of adverse events

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (fractionated SRS)Experimental Treatment3 Interventions

Patients undergo fractionated SRS.

Group II: Arm A (single fraction SRS)Experimental Treatment3 Interventions

Patients undergo single fraction SRS.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Stereotactic Radiosurgery

2016

Completed Phase 2

~460

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,071 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,452 Total Patients Enrolled

Paul D BrownPrincipal InvestigatorMayo Clinic in Rochester

Media Library

Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05222620 — Phase 2

$Brain Metastasis Research Study Groups: Arm A (single fraction SRS), Arm B (fractionated SRS)$

Brain Metastasis Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT05222620 — Phase 2

Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05222620 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any openings in this trial?

"This medical study is still actively enrolling participants, as evidenced on clinicaltrials.gov; it was initially posted and last updated on March 14th 2022."

Answered by AI

What potential adverse effects could a patient endure from this treatment?

"This treatment has been evaluated to have a safety rating of 2, as this is a Phase 2 trial. This means the medication's security profile is known but its efficacy remains uncertain."

Answered by AI

How many participants are currently included in the research study?

"Affirmative, the information available on clinicaltrials.gov points towards active recruitment for this study which was initiated on March 14th 2022 and last revised at the same date. This trial is searching for up to 69 individuals across only one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222620.