Recruiting
Phase 3

Stereotactic Radiosurgery

Sponsor:

Mayo Clinic

Code:

NCT03750227

Conditions

Malignant Solid Neoplasm

Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conventional Surgery

Questionnaire Administration

Stereotactic Radiosurgery

Computed Tomography

Magnetic Resonance Imaging

Study Details

Brief summary:

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.

Conditions

Malignant Solid Neoplasm

Metastatic Malignant Neoplasm in the Brain

Study ID

NCT03750227

Start date

Nov 19, 2018

Status verified date

Aug, 2026

Completion date

Nov 8, 2030

Anticipated

Primary completion date

Nov 8, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18 years
  • Histological or cytological confirmation of solid tumor malignancy and/or clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings
  • Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate
  • Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=< 10 metastases)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
  • Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent
  • Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally

Exclusion Criteria:

  • Any of the following:

  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. \* NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Prior open neurosurgery for malignancy
  • Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma
  • History of whole brain radiation therapy (WBRT)
  • Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible
  • Leptomeningeal metastasis/disease
  • A brain metastasis that is located =< 5 mm of the optic chiasm
  • Any brain metastasis > 5 cm in size
  • > 10 brain metastases
  • Indication for surgical resection of >= 2 brain metastases
  • Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab
  • Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Conventional Surgery

Undergo surgery

Questionnaire Administration

Ancillary studies

Stereotactic Radiosurgery

Undergo stereotactic radiosurgery

Computed Tomography

Undergo CT

Magnetic Resonance Imaging

Undergo MRI

Biospecimen Collection

Undergo blood sample, tissue and CSF sample collection

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 and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Sujay A. Vora, M.D.

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Daniel Trifiletti, M.D.

NIH Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

DeeDee K. Smart, M.D., Ph.D.

301-496-5457smartd@mail.nih.gov

Principal Investigator:

DeeDee K. Smart, M.D., Ph.D.

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Elizabeth S. Yan, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-19.