Malignant Solid NeoplasmPhase 3NCT03750227
Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors
A Phase 3 study testing Conventional Surgery, Questionnaire Administration and Stereotactic Radiosurgery in people with Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by Mayo Clinic at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Conventional Surgery, Questionnaire Administration and Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Nov 2018to 8 Nov 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
NIH Clinical Center
Bethesda, Maryland, 20892
DeeDee K. Smart, M.D., Ph.D., 301-496-5457, smartd@mail.nih.gov
DeeDee K. Smart, M.D., Ph.D.
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Daniel Trifiletti, M.D.
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Elizabeth S. Yan, M.D.
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Sujay A. Vora, M.D.
About this study
Official title: Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine for patients with brain metastases meeting the inclusion criteria, whether there is an increase in the time to a composite endpoint of adverse outcomes including the first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
SECONDARY OBJECTIVES:
- To determine for patients with brain metastases whether there is improved overall survival for patients who receive SRS prior to surgery as compared to patients who receive SRS after surgery.
II. To determine for patients with brain metastases whether there are improved patient reported outcomes including quality of life for patients who receive SRS prior to surgery as compared to patients who receive SRS after surgery.
III. To determine if preoperative SRS increases rates of surgical morbidity including postoperative complications such as wound infection, need for longer hospital stays, or readmission compared to a surgery first approach for resectable brain metastases.
IV. To determine for patients with brain metastases whether there is a higher rate of completion of planned therapies for patients who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
- To determine for patients with brain metastases whether there is a shorter time to initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS.
VI. To determine for patients treated with pre-operative SRS whether there is a longer interval to regional progression, any central nervous system (CNS) progression or need for subsequent intracranial treatment compared to patients receiving post-operative SRS.
VII. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of radiation necrosis, including asymptomatic and symptomatic radiation necrosis.
VIII. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of local recurrence.
IX. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of leptomeningeal disease.
CORRELATIVE RESEARCH OBJECTIVES:
- To determine the genetic and molecular alterations of brain metastases seen after radiation versus in the setting of resection alone, including early radiobiologic changes in tissue treated with SRS 24 to 48 hours prior, and to investigate detection rate of corresponding circulating deoxyribonucleic acid (DNA) and/or inflammatory markers in peripheral specimens.
II. To investigate the usefulness of biomarkers and response to radiation in predicting local control and outcomes.
III. To look at cell capture of tumor cells as well as cell free DNA in cerebrospinal fluid (CSF) sampled at the time of surgery, comparing patients receiving neoadjuvant treatment to those that have not.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery.
ARM B: Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery.
Patients also undergo a planning computed tomography (CT) or magnetic resonance imaging (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.
After completion of study treatment, patients are followed up at 2 weeks, every 3-4 months for up to 2 years and then periodically for up to 3 years.
- Being tested
- Conventional Surgery, Questionnaire Administration, Stereotactic Radiosurgery, Computed Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional SurgeryProcedure or surgery
Undergo surgery
Questionnaire AdministrationOther
Ancillary studies
Stereotactic RadiosurgeryRadiation
Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiotherapy
Undergo stereotactic radiosurgery
Computed TomographyProcedure or surgery
Also called CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRI
Undergo MRI
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Specimen Collection
Undergo blood sample, tissue and CSF sample collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Surgery; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central nervous system (CNS) composite endpoint event (CNS-CE event)
The CNS-CE event distributions will be estimated using the Kaplan-Meier method.
Measured: Time from study randomization to documentation of the first CNS-CE event, assessed up to 5 years
Secondary outcomes (11)
Overall survival (OS)
Defined as the time from start of study therapy to death due to any cause.
Measured: Up to 5 years
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.
Measured: Up to 5 years post treatment
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.
Measured: Up to 5 years
CNS-CE event free rate
The 6-month CNS-CE rates from the Kaplan-Meier analysis will be compared between the arms.
Measured: At 6 months
Patient-reported outcome - Quality of Life (QOL)
QOL will be assessed via changes in the Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) Global score. The FACT-Br consists of 20 statements answered on a 5-point scale (not at all, a little bit, somewhat, quite a bit, or very much) related to quality of life over the past 7 days.
Measured: Baseline to 6 months post treatment
Rate of completion of therapies
The rate of completion of planned therapies will be compared using Chi-square or Fisher's exact tests between the 2 treatment groups.
Measured: Up to 5 years post treatment
Time to systemic therapy
Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
Measured: Time to initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS, assessed up to 5 years
Time to regional progression
Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
Measured: Up to 5 years post treatment
Time central nervous system (CNS) progression
Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
Measured: Up to 5 years post treatment
Time to subsequent treatment, including whole-brain radiotherapy (WBRT)
Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
Measured: Up to 5 years
Rate of neurosurgical morbidity
The rates of surgical morbidity including postoperative complications such as wound infection, need for longer hospital stays, or readmission will be compared using Chi-square or Fisher's exact tests between the 2 treatment groups.
Measured: Up to 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start19 Nov 2018
- Primary completion8 Nov 2030 (estimated)
- Study completion8 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Yan, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750227
- Sponsor's protocol ID
- MC167C
- Other IDs
- NCI-2018-02799, 17-007708, MC167C
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2018
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 38475765
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT03750227
- Acronym / sponsor ID
- MC167C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 8 Nov 2030 (estimated)
- Study completion
- 8 Nov 2030 (estimated)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine for patients with brain metastases meeting the inclusion criteria, whether there is an increase in the time to a composite endpoint of adverse outcomes including the first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic radiation brain necrosis in patients who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
SECONDARY OBJECTIVES:
- To determine for patients with brain metastases whether there is improved overall survival for patients who receive SRS prior to surgery as compared to patients who receive SRS after surgery.
II. To determine for patients with brain metastases whether there are improved patient reported outcomes including quality of life for patients who receive SRS prior to surgery as compared to patients who receive SRS after surgery.
III. To determine if preoperative SRS increases rates of surgical morbidity including postoperative complications such as wound infection, need for longer hospital stays, or readmission compared to a surgery first approach for resectable brain metastases.
IV. To determine for patients with brain metastases whether there is a higher rate of completion of planned therapies for patients who receive SRS prior to surgery as compared to patients who receive surgery prior to SRS.
- To determine for patients with brain metastases whether there is a shorter time to initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS.
VI. To determine for patients treated with pre-operative SRS whether there is a longer interval to regional progression, any central nervous system (CNS) progression or need for subsequent intracranial treatment compared to patients receiving post-operative SRS.
VII. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of radiation necrosis, including asymptomatic and symptomatic radiation necrosis.
VIII. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of local recurrence.
IX. To determine for patients with pre-operative as compared to post-operative radiation whether there is a decreased rate of leptomeningeal disease.
CORRELATIVE RESEARCH OBJECTIVES:
- To determine the genetic and molecular alterations of brain metastases seen after radiation versus in the setting of resection alone, including early radiobiologic changes in tissue treated with SRS 24 to 48 hours prior, and to investigate detection rate of corresponding circulating deoxyribonucleic acid (DNA) and/or inflammatory markers in peripheral specimens.
II. To investigate the usefulness of biomarkers and response to radiation in predicting local control and outcomes.
III. To look at cell capture of tumor cells as well as cell free DNA in cerebrospinal fluid (CSF) sampled at the time of surgery, comparing patients receiving neoadjuvant treatment to those that have not.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery.
ARM B: Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery.
Patients also undergo a planning computed tomography (CT) or magnetic resonance imaging (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.
After completion of study treatment, patients are followed up at 2 weeks, every 3-4 months for up to 2 years and then periodically for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Post-operative SRS) | Active comparator | Procedure: Conventional Surgery, Other: Questionnaire Administration, Radiation: Stereotactic Radiosurgery, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen CollectionPatients 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. |
| Arm B (Pre-operative SRS) | Experimental | Procedure: Conventional Surgery, Other: Questionnaire Administration, Radiation: Stereotactic Radiosurgery, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen CollectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- Any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional SurgeryUndergo surgery | Procedure or surgery | Arm A (Post-operative SRS), Arm B (Pre-operative SRS) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (Post-operative SRS), Arm B (Pre-operative SRS) |
| Stereotactic RadiosurgeryAlso: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic RadiotherapyUndergo stereotactic radiosurgery | Radiation | Arm A (Post-operative SRS), Arm B (Pre-operative SRS) |
| Computed TomographyAlso: CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized TomographyUndergo CT | Procedure or surgery | Arm A (Post-operative SRS), Arm B (Pre-operative SRS) |
| Magnetic Resonance ImagingAlso: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MRIUndergo MRI | Procedure or surgery | Arm A (Post-operative SRS), Arm B (Pre-operative SRS) |
| Biospecimen CollectionAlso: Biological Sample Collection, Specimen CollectionUndergo blood sample, tissue and CSF sample collection | Procedure or surgery | Arm A (Post-operative SRS), Arm B (Pre-operative SRS) |
Primary outcome
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
The CNS-CE event distributions will be estimated using the Kaplan-Meier method.
11 secondary outcomes
Overall survival (OS)
Time frame: Up to 5 years
Incidence of adverse events
Time frame: Up to 5 years post treatment
CNS-CE event free survival time adjusted for stratification factors
Time frame: Up to 5 years
CNS-CE event free rate
Time frame: At 6 months
Patient-reported outcome - Quality of Life (QOL)
Time frame: Baseline to 6 months post treatment
Rate of completion of therapies
Time frame: Up to 5 years post treatment
Time to systemic therapy
Time frame: Time to initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS, assessed up to 5 years
Time to regional progression
Time frame: Up to 5 years post treatment
Time central nervous system (CNS) progression
Time frame: Up to 5 years post treatment
Time to subsequent treatment, including whole-brain radiotherapy (WBRT)
Time frame: Up to 5 years
Rate of neurosurgical morbidity
Time frame: Up to 5 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 38475765Routman 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Yan, M.D. principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional Surgery, Questionnaire Administration and Stereotactic Radiosurgery in people with Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, run by Mayo Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03750227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.