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

NCT05222620 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Solid Neoplasm

Interventions

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Stereotactic Radiosurgery

Undergo single fraction SRS

RADIATION

Stereotactic Radiosurgery

Undergo fractionated SRS

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Sponsors & Collaborators

Principal Investigators

  • Paul D. Brown, MD · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2027-02-15
Completion
2028-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222620 on ClinicalTrials.gov