<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03750227</url>
  </required_header>
  <id_info>
    <org_study_id>MC167C</org_study_id>
    <secondary_id>NCI-2018-02799</secondary_id>
    <secondary_id>17-007708</secondary_id>
    <secondary_id>MC167C</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <nct_id>NCT03750227</nct_id>
  </id_info>
  <brief_title>Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors</brief_title>
  <official_title>Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS)&#xD;
      works before or after surgery in patients with tumors that has spread to the brain or that&#xD;
      can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that&#xD;
      delivers a single, high dose of radiation directly to the tumor and may cause less damage to&#xD;
      normal tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine for patients with brain metastases meeting the inclusion criteria, whether&#xD;
      there is an increase in the time to a composite endpoint of adverse outcomes including the&#xD;
      first occurrence of either: local recurrence, leptomeningeal disease, or symptomatic&#xD;
      radiation brain necrosis in patients who receive SRS prior to surgery as compared to patients&#xD;
      who receive surgery prior to SRS.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine for patients with brain metastases whether there is improved overall survival&#xD;
      for patients who receive SRS prior to surgery as compared to patients who receive SRS after&#xD;
      surgery.&#xD;
&#xD;
      II. To determine for patients with brain metastases whether there are improved patient&#xD;
      reported outcomes including quality of life for patients who receive SRS prior to surgery as&#xD;
      compared to patients who receive SRS after surgery.&#xD;
&#xD;
      III. To determine if preoperative SRS increases rates of surgical morbidity including&#xD;
      postoperative complications such as wound infection, need for longer hospital stays, or&#xD;
      readmission compared to a surgery first approach for resectable brain metastases.&#xD;
&#xD;
      IV. To determine for patients with brain metastases whether there is a higher rate of&#xD;
      completion of planned therapies for patients who receive SRS prior to surgery as compared to&#xD;
      patients who receive surgery prior to SRS.&#xD;
&#xD;
      V. To determine for patients with brain metastases whether there is a shorter time to&#xD;
      initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS.&#xD;
&#xD;
      VI. To determine for patients treated with pre-operative SRS whether there is a longer&#xD;
      interval to regional progression, any central nervous system (CNS) progression or need for&#xD;
      subsequent intracranial treatment compared to patients receiving post-operative SRS.&#xD;
&#xD;
      VII. To determine for patients with pre-operative as compared to post-operative radiation&#xD;
      whether there is a decreased rate of radiation necrosis, including asymptomatic and&#xD;
      symptomatic radiation necrosis.&#xD;
&#xD;
      VIII. To determine for patients with pre-operative as compared to post-operative radiation&#xD;
      whether there is a decreased rate of local recurrence.&#xD;
&#xD;
      IX. To determine for patients with pre-operative as compared to post-operative radiation&#xD;
      whether there is a decreased rate of leptomeningeal disease.&#xD;
&#xD;
      CORRELATIVE RESEARCH OBJECTIVES:&#xD;
&#xD;
      I. To determine the genetic and molecular alterations of brain metastases seen after&#xD;
      radiation versus in the setting of resection alone, including early radiobiologic changes in&#xD;
      tissue treated with SRS 24 to 48 hours prior, and to investigate detection rate of&#xD;
      corresponding circulating deoxyribonucleic acid (DNA) and/or inflammatory markers in&#xD;
      peripheral specimens.&#xD;
&#xD;
      II. To investigate the usefulness of biomarkers and response to radiation in predicting local&#xD;
      control and outcomes.&#xD;
&#xD;
      III. To look at cell capture of tumor cells as well as cell free DNA in cerebrospinal fluid&#xD;
      (CSF) sampled at the time of surgery, comparing patients receiving neoadjuvant treatment to&#xD;
      those that have not.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM A: Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic&#xD;
      radiosurgery.&#xD;
&#xD;
      ARM B: Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo&#xD;
      surgery.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 2 weeks, every 3-4 months&#xD;
      for up to 2 years and then periodically for up to 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Anticipated">November 8, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 8, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central nervous system (CNS) composite endpoint event (CNS-CE event)</measure>
    <time_frame>Time from study randomization to documentation of the first CNS-CE event, assessed up to 5 years</time_frame>
    <description>The CNS-CE event distributions will be estimated using the Kaplan-Meier method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From start of study therapy to death due to any cause, assessed up to 5 years</time_frame>
    <description>The distribution of overall survival for both groups of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CNS-CE event free survival time adjusted for stratification factors</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CNS-CE event free rate</measure>
    <time_frame>At 6 months</time_frame>
    <description>The 6-month CNS-CE rates from the Kaplan-Meier analysis will be compared between the arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome - Quality of Life (QOL)</measure>
    <time_frame>Baseline to 6 months post treatment</time_frame>
    <description>QOL will be assessed via changes in the Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) Global score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of completion of therapies</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>The rate of completion of planned therapies will be compared using Chi-square or Fisher's exact tests between the 2 treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to systemic therapy</measure>
    <time_frame>Time to initiation or re-initiation of systemic therapy with pre-operative versus post-operative SRS, assessed up to 5 years</time_frame>
    <description>Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to regional progression</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time central nervous system (CNS) progression</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to subsequent treatment, including whole-brain radiotherapy (WBRT)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of neurosurgical morbidity</measure>
    <time_frame>Up to 5 years post treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Malignant Solid Neoplasm</condition>
  <condition>Metastatic Malignant Neoplasm in the Brain</condition>
  <arm_group>
    <arm_group_label>Arm A (Post-operative SRS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (Pre-operative SRS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Surgery</intervention_name>
    <description>Undergo surgery</description>
    <arm_group_label>Arm A (Post-operative SRS)</arm_group_label>
    <arm_group_label>Arm B (Pre-operative SRS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (Post-operative SRS)</arm_group_label>
    <arm_group_label>Arm B (Pre-operative SRS)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (Post-operative SRS)</arm_group_label>
    <arm_group_label>Arm B (Pre-operative SRS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Radiosurgery</intervention_name>
    <description>Undergo stereotactic radiosurgery</description>
    <arm_group_label>Arm A (Post-operative SRS)</arm_group_label>
    <arm_group_label>Arm B (Pre-operative SRS)</arm_group_label>
    <other_name>Stereotactic External Beam Irradiation</other_name>
    <other_name>stereotactic external-beam radiation therapy</other_name>
    <other_name>Stereotactic Radiation Therapy</other_name>
    <other_name>Stereotactic Radiotherapy</other_name>
    <other_name>stereotaxic radiation therapy</other_name>
    <other_name>stereotaxic radiosurgery</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Histological or cytological confirmation of solid tumor malignancy and/or clinical&#xD;
             history of known or suspected metastatic disease with an intraparenchymal brain tumor&#xD;
             consistent with brain metastasis based on clinical and radiologic findings&#xD;
&#xD;
          -  Clinical indication for surgical resection of one brain metastasis based on&#xD;
             neurosurgery recommendation and patient deemed a surgical candidate&#xD;
&#xD;
          -  Clinical indication and plan for stereotactic radiosurgery to all known brain lesions&#xD;
             requiring treatment (=&lt; 10 metastases)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) =&lt; 2&#xD;
&#xD;
          -  Provide written informed consent or have a legally authorized representative who is&#xD;
             responsible for the care and well-being of the potential study participant, provide&#xD;
             consent&#xD;
&#xD;
          -  Willing to return to enrolling institution for follow-up (during the active monitoring&#xD;
             phase of the study) or agreement to complete pre-specified magnetic resonance imaging&#xD;
             (MRI) series and follow-up visits according to the study timeline mailing in digital&#xD;
             copies of images as well as clinical notes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following:&#xD;
&#xD;
               -  Pregnant women&#xD;
&#xD;
               -  Nursing women&#xD;
&#xD;
               -  Men or women of childbearing potential who are unwilling to employ adequate&#xD;
                  contraception&#xD;
&#xD;
          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment&#xD;
             of the investigator, would make the patient inappropriate for entry into this study or&#xD;
             interfere significantly with the proper assessment of safety and toxicity of the&#xD;
             prescribed regimens&#xD;
&#xD;
          -  Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)&#xD;
             positive and currently receiving antiretroviral therapy. * NOTE: Patients known to be&#xD;
             HIV, but without clinical evidence of an immunocompromised state, are eligible for&#xD;
             this trial&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Prior open neurosurgery for malignancy&#xD;
&#xD;
          -  Known or clinically suspected primary germ cell tumor, small cell carcinoma, or&#xD;
             lymphoma&#xD;
&#xD;
          -  History of whole brain radiation therapy (WBRT)&#xD;
&#xD;
          -  Known allergy to gadolinium, pacemaker, or other contraindication such as metal&#xD;
             implant that is not safe for MRI. Patients with MRI-compatible implants including MRI&#xD;
             compatible pacemakers are eligible&#xD;
&#xD;
          -  Leptomeningeal metastasis/disease&#xD;
&#xD;
          -  A brain metastasis that is located =&lt; 5 mm of the optic chiasm&#xD;
&#xD;
          -  Any brain metastasis &gt; 5 cm in size&#xD;
&#xD;
          -  &gt; 10 brain metastases&#xD;
&#xD;
          -  Indication for surgical resection of &gt;= 2 brain metastases&#xD;
&#xD;
          -  Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone&#xD;
             equivalent of steroids or bevacizumab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Yan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Sujay A. Vora, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Daniel Trifiletti, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Elizabeth S. Yan, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750227
org study id: MC167C
secondary id: NCI-2018-02799
secondary id: 17-007708
secondary id: MC167C
secondary id: P30CA015083
nct id: NCT03750227
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
PRIMARY OBJECTIVE:

      I. 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:

      I. 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.

      V. 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:

      I. 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.

      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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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
description: The CNS-CE event distributions will be estimated using the Kaplan-Meier method.
measure: Overall survival (OS)
time frame: From start of study therapy to death due to any cause, assessed up to 5 years
description: The distribution of overall survival for both groups of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.
measure: Incidence of adverse events
time frame: Up to 5 years post treatment
description: 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.
measure: CNS-CE event free survival time adjusted for stratification factors
time frame: Up to 5 years
description: 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.
measure: CNS-CE event free rate
time frame: At 6 months
description: The 6-month CNS-CE rates from the Kaplan-Meier analysis will be compared between the arms.
measure: Patient-reported outcome - Quality of Life (QOL)
time frame: Baseline to 6 months post treatment
description: QOL will be assessed via changes in the Functional Assessment of Cancer Therapy Scale-Brain (FACT-Br) Global score
measure: Rate of completion of therapies
time frame: Up to 5 years post treatment
description: The rate of completion of planned therapies will be compared using Chi-square or Fisher's exact tests between the 2 treatment groups.
measure: 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
description: Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
measure: Time to regional progression
time frame: Up to 5 years post treatment
description: Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
measure: Time central nervous system (CNS) progression
time frame: Up to 5 years post treatment
description: Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
measure: Time to subsequent treatment, including whole-brain radiotherapy (WBRT)
time frame: Up to 5 years
description: Will be estimated using the Kaplan-Meier method, and will be compared using log-rank tests.
measure: Rate of neurosurgical morbidity
time frame: Up to 5 years post treatment
description: 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.
arm group label: Arm A (Post-operative SRS)
arm group type: Active Comparator
description: Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery.
arm group label: Arm B (Pre-operative SRS)
arm group type: Experimental
description: Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery.
intervention type: Procedure
intervention name: Conventional Surgery
description: Undergo surgery
arm group label: Arm A (Post-operative SRS)
arm group label: Arm B (Pre-operative SRS)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm A (Post-operative SRS)
arm group label: Arm B (Pre-operative SRS)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm A (Post-operative SRS)
arm group label: Arm B (Pre-operative SRS)
intervention type: Radiation
intervention name: Stereotactic Radiosurgery
description: Undergo stereotactic radiosurgery
arm group label: Arm A (Post-operative SRS)
arm group label: Arm B (Pre-operative SRS)
other name: Stereotactic External Beam Irradiation
other name: stereotactic external-beam radiation therapy
other name: Stereotactic Radiation Therapy
other name: Stereotactic Radiotherapy
other name: stereotaxic radiation therapy
other name: stereotaxic radiosurgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Yan
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms