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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05222620
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Questionnaire Administration — OTHER
    Ancillary studies
  • Stereotactic Radiosurgery — RADIATION
    Undergo single fraction SRS
  • Stereotactic Radiosurgery — RADIATION
    Undergo fractionated SRS
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Mar 14, 2022
Status verified
Apr 2026
Primary completion
Feb 15, 2027
Completion
Feb 15, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Arm A (single fraction SRS)
    Patients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.
  • Other: Arm B (fractionated SRS)
    Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days.. Patients also undergo MRI at screening and during follow up.

Primary Outcome Measure

Time to local failure or symptomatic radiation brain necrosis of large brain metastasis [ Time Frame: Up to 5 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Sujay A. Vora, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
[email protected]
855-776-0015
Jennifer L. Peterson, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System in Albert LeaAlbert LeaMinnesota56007
Clinical Trials Referral Office
[email protected]
855-776-0015
Lori Rhodes
[email protected]
507-284-0063
John Yeakel, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health Systems-MankatoMankatoMinnesota56001
Clinical Trials Referral Office
[email protected]
855-776-0015
Lori Rhodes
[email protected]
507-284-0063
Jason T. Hayes, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Paul D. Brown, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Eau Claire ClinicEau ClaireWisconsin54701
Clinical Trials Referral Office
[email protected]
855-776-0015
Lori Rhodes
[email protected]
507-284-0063
Now Bahar Alam, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Franciscan HealthcareLa CrosseWisconsin54601
Clinical Trials Referral Office
[email protected]
855-776-0015
Lori Rhodes
[email protected]
507-284-0063
Abigail L. Stockham, MD (PRINCIPAL_INVESTIGATOR)

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