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

NCT03750227 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: MC167CNCI-2018-0279917-007708
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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

Metastatic Malignant Neoplasm in the Brain; Malignant Solid Neoplasm

Outcome Measures

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 from study randomization to documentation of the first CNS-CE event, assessed up to 5 years

Secondary Outcomes (11)

• Overall survival (OS)

  Up to 5 years

• Incidence of adverse events

  Up to 5 years post treatment

• CNS-CE event free survival time adjusted for stratification factors

  Up to 5 years

• CNS-CE event free rate

  At 6 months

• Patient-reported outcome - Quality of Life (QOL)

  Baseline to 6 months post treatment

Study Arms (2)

Arm A (Post-operative SRS)

ACTIVE COMPARATOR

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.

Procedure: Conventional Surgery; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Arm B (Pre-operative SRS)

EXPERIMENTAL

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.

Procedure: Conventional Surgery; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm A (Post-operative SRS); Arm B (Pre-operative SRS)

Stereotactic Radiosurgery RADIATION

Undergo stereotactic radiosurgery

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery, SRS

Arm A (Post-operative SRS); Arm B (Pre-operative SRS)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan

Arm A (Post-operative SRS); Arm B (Pre-operative SRS)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, Structural MRI, sMRI

Arm A (Post-operative SRS); Arm B (Pre-operative SRS)

Biospecimen Collection PROCEDURE

Undergo blood sample, tissue and CSF sample collection

Also known as: Biological Sample Collection, Specimen Collection

Arm A (Post-operative SRS); Arm B (Pre-operative SRS)

Conventional Surgery PROCEDURE

Undergo surgery

Arm A (Post-operative SRS); Arm B (Pre-operative SRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

National Institutes of Neurological Disorders and Stroke, NIH

Bethesda, Maryland, 20892, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• Routman DM, Jusue-Torres I, Brown PD, Trifiletti DM, Vora SA, Brown DA, Parney IF, Burns TC, Yan E. Pre-operative vs. post-operative stereotactic radiosurgery for operative metastatic brain tumors: study protocol for a phase III clinical trial. BMC Cancer. 2024 Mar 12;24(1):332. doi: 10.1186/s12885-024-12060-9.

  PMID: 38475765 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery; Magnetic Resonance Spectroscopy; X-Rays; Specimen Handling

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Elizabeth Yan, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 21, 2018
• Study Start: November 19, 2018
• Primary Completion (Estimated): November 8, 2030
• Study Completion (Estimated): November 8, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (4)