Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT03750227
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

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

Interventions

  • Conventional Surgery — PROCEDURE
    Undergo surgery
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Stereotactic Radiosurgery — RADIATION
    Undergo stereotactic radiosurgery
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample, tissue and CSF sample collection

Study Details

This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Key Dates

Start date
Nov 19, 2018
Status verified
Dec 2025
Primary completion
Nov 8, 2030
Completion
Nov 8, 2030

Study Design

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

Arms

  • Active Comparator: Arm A (Post-operative SRS)
    Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery. Patients also undergo a planning CT or MRI before radiation and tissue and CSF sample collection at time of surgery. Additionally, patients undergo MRI and option blood sample collection throughout the study.
  • Experimental: Arm B (Pre-operative SRS)
    Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery. Patients also undergo a planning CT or MRI before radiation and tissue and CSF sample collection at time of surgery and MRI throughout the study. Additionally, patients undergo MRI and option blood sample collection throughout the study.

Primary Outcome Measure

Central nervous system (CNS) composite endpoint event (CNS-CE event) [ Time Frame: Time from study randomization to documentation of the first CNS-CE event, assessed up to 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Sujay A. Vora, M.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Daniel Trifiletti, M.D. (PRINCIPAL_INVESTIGATOR)
National Institutes of Neurological Disorders and Stroke, NIHBethesdaMaryland20892
DeeDee K. Brown, M.D., Ph.D.
[email protected]
301-496-5457
DeeDee K. Smart, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Elizabeth S. Yan, M.D. (PRINCIPAL_INVESTIGATOR)

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