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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Conventional Surgery
Procedure/SurgeryUndergo surgery
Questionnaire Administration
Other interventionAncillary studies
Stereotactic Radiosurgery
RadiationUndergo stereotactic radiosurgery
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Biospecimen Collection
Procedure/SurgeryUndergo blood sample, tissue and CSF sample collection
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Arm A (Post-operative SRS)Active comparator 6 interventions
Group B: Arm B (Pre-operative SRS)Experimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
Central nervous system (CNS) composite endpoint event (CNS-CE event)
The CNS-CE event distributions will be estimated using the Kaplan-Meier method.
Time frame
Time from study randomization to documentation of the first CNS-CE event, assessed up to 5 yearsSecondary outcomes
1
Overall survival (OS)
Defined as the time from start of study therapy to death due to any cause.
Time frame
Up to 5 years2
Incidence of adverse events
Will be graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The overall adverse event rates for grade 3 or higher adverse events will be compared using Chi-square or Fisher's exact tests between the 2 treatment groups.
Time frame
Up to 5 years post treatment3
CNS-CE event free survival time adjusted for stratification factors
Cox-models will be used that incorporate the stratification factors to test for differences in treatment arms after adjusting for stratification factors listed in section 5.0.
Time frame
Up to 5 years4
CNS-CE event free rate
The 6-month CNS-CE rates from the Kaplan-Meier analysis will be compared between the arms.
Time frame
At 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov