RecruitingPhase 2NCT05222620

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

Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)


Sponsor

Mayo Clinic

Enrollment

90 participants

Start Date

Mar 14, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of focused brain radiation for cancer that has spread to the brain: standard single-session radiosurgery (SRS) versus a divided multi-session approach (FSRS). The goal is to see which method better controls tumors while reducing side effects. **You may be eligible if...** - You are 18 or older - You have one or more brain metastases (cancer that has spread to the brain from elsewhere in the body, such as lung or breast cancer) - At least one tumor is between 5 mm and 4 cm in size and has not been previously treated with radiation - You are well enough to undergo the procedure **You may NOT be eligible if...** - You have more than a certain number of brain tumors (limits apply) - Your brain tumor(s) have already been treated with brain radiation - You have certain types of tumors not suitable for radiosurgery (e.g., some lymphomas or small cell cancers) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONStereotactic Radiosurgery

Undergo single fraction SRS

RADIATIONStereotactic Radiosurgery

Undergo fractionated SRS

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(7)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05222620


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