Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Conventional Surgery
- Questionnaire Administration
- Stereotactic Radiosurgery
- Computed Tomography
- Magnetic Resonance Imaging
- Biospecimen Collection
Treatment groups
140 Participants
are divided into 2 treatment groupsLocations
4Mayo Clinic in Arizona85259, ScottsdaleArizona, United States
Mayo Clinic in Florida32224-9980, JacksonvilleFlorida, United States
National Institutes of Neurological Disorders and Stroke, NIH20892, BethesdaMaryland, United States
Mayo Clinic in Rochester55905, RochesterMinnesota, United States
Sponsors and collaborators
Mayo Clinic
Lead sponsor
Source ClinicalTrials.gov