<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/NCT04422639</url>
  </required_header>
  <id_info>
    <org_study_id>260505</org_study_id>
    <nct_id>NCT04422639</nct_id>
  </id_info>
  <brief_title>Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases</brief_title>
  <official_title>A Phase II Pilot Trial of Preoperative SRS/SRT Versus Postoperative SRS/SRT for Brain Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial&#xD;
      conducted at a single study site (UAMS). Subjects will be randomized to one of the 2&#xD;
      treatment arms and stratified by size of index lesion and number of brain metastases.&#xD;
&#xD;
      The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to&#xD;
      postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain&#xD;
      metastases.&#xD;
&#xD;
      The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain&#xD;
      metastases will result in improved freedom from Central Nervous System (CNS) events when&#xD;
      compared to adjuvant SRS/SRT after surgical resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Following the EAB for NCI Designation this study was identified as having no funding and not&#xD;
    meeting enrollment goals. It was requested by the EAB that this study be closed due to&#xD;
    inactivity.&#xD;
  </why_stopped>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Actual">March 27, 2023</completion_date>
  <primary_completion_date type="Actual">March 27, 2023</primary_completion_date>
  <phase>N/A</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>Number of Participants With Central Nervous System (CNS) Composite Event (CE)</measure>
    <time_frame>From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.</time_frame>
    <description>A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Brain Metastases</condition>
  <arm_group>
    <arm_group_label>Arm I (pre-operative SRS/SRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (post-operative SRS/SRT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>SRS/SRT</intervention_name>
    <description>Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
    <arm_group_label>Arm I (pre-operative SRS/SRT)</arm_group_label>
    <arm_group_label>Arm II (post-operative SRS/SRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with prior histopathological diagnosis of cancer other than small cell lung&#xD;
             cancer, lymphoma, and germ cell histologies.&#xD;
&#xD;
          -  MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as&#xD;
             assessed by the radiologist.&#xD;
&#xD;
          -  Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for&#xD;
             participation in this study, including the ability to tolerate both surgery and&#xD;
             SRS/SRT, e.g., the ability to lie flat in a stereotactic soft head frame.&#xD;
&#xD;
          -  ECOG ≤ 2&#xD;
&#xD;
          -  1-2 index lesion(s) appropriate for resection, not previously treated with SRS/SRT.&#xD;
&#xD;
        Index lesion(s) should be &gt; 2 cm and &lt; 5 cm in largest dimension, and require resection.&#xD;
        Alternatively, patients with a diagnosis of melanoma and a lesion &lt; 1.5cm in largest&#xD;
        dimension may also be included. o All other brain lesions must be appropriate for SRS/SRT&#xD;
        alone and treated according to physician preference. Prior neurosurgery and/or prior&#xD;
        SRS/SRT at a non-overlapping location are permitted at the discretion of the treating&#xD;
        physician.&#xD;
&#xD;
        - MRI confirmed 1-10 lesions, 1-2 of which are the index lesions undergoing surgery.&#xD;
&#xD;
        Each non-index lesion (up to 10) must measure ≤ 3.0 cm in maximal extent on contrasted MRI&#xD;
        scan, and not otherwise require resection.&#xD;
&#xD;
          -  Clinical indication and plan for stereotactic radiosurgery to all known brain lesions&#xD;
             requiring treatment (≤ 10 metastases).&#xD;
&#xD;
          -  Surgical resection able to be performed within 15 days of radiotherapy completion.&#xD;
&#xD;
          -  Written informed consent obtained from subject, or a legally designated power of&#xD;
             attorney and ability for subject to comply with the requirements of the study.&#xD;
&#xD;
          -  Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of&#xD;
             radiation. WOCBP is a female patient less than 50 years of age or who has menstruated&#xD;
             within the last 12 months.&#xD;
&#xD;
          -  Platelet count &gt; 80 k/cumm, Hgb &gt; 7.5 gm/dL, INR &lt; 1.3, ANC &gt; 1.5 k/cumm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a surgical candidate per neurosurgeon's discretion.&#xD;
&#xD;
          -  Contraindication to general anesthesia.&#xD;
&#xD;
          -  Not a radiosurgical candidate per radiation oncologist's discretion.&#xD;
&#xD;
          -  Metastatic germ cell tumor, small cell carcinoma, leukemia, multiple myeloma or&#xD;
             lymphoma or any primary brain tumor&#xD;
&#xD;
          -  ECOG &gt; 2&#xD;
&#xD;
          -  &lt; 3 months expected survival&#xD;
&#xD;
          -  Radiologic documentation of hydrocephalus in addition to symptoms of hydrocephalus&#xD;
&#xD;
          -  Radiographic or cytologic evidence of leptomeningeal disease.&#xD;
&#xD;
          -  Imaging Findings:&#xD;
&#xD;
               -  Midline shift &gt; 6mm&#xD;
&#xD;
               -  &gt;10 lesions, one of which is the index lesion&#xD;
&#xD;
               -  Largest lesion &gt; 5cm&#xD;
&#xD;
          -  Pregnancy&#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 are eligible.&#xD;
&#xD;
          -  Patients who have local recurrence of previously treated brain metastasis.&#xD;
&#xD;
          -  Patients who have received prior WBRT.&#xD;
&#xD;
          -  Inherited radiation hypersensitivity syndromes&#xD;
&#xD;
             o Ataxia Telangiectasia, Nijmegen Breakage Syndrome, Fanconi Anemia, DNA Ligase IV,&#xD;
             Mre 11 deficiency, SCID, Bloom's syndrome&#xD;
&#xD;
          -  Collagen vascular diseases&#xD;
&#xD;
             o Active systemic lupus erythematous (SLE), scleroderma, mixed connective tissue&#xD;
             disorder, polymyositis or dermatomyositis, CREST Syndrome&#xD;
&#xD;
          -  Cytotoxic Chemotherapy within 7 days prior to SRS/SRT.&#xD;
&#xD;
             o Molecularly targeted therapies, including immune-modulatory drugs, can be given&#xD;
             within 7 days of SRS/SRT at the discretion of the treating physician.&#xD;
&#xD;
          -  Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there&#xD;
             is increased risk of fatal brain hemorrhage with surgical resection.&#xD;
&#xD;
          -  Treatment plan respecting normal tissue tolerances using dose fractionation specified&#xD;
             within the protocol cannot be achieved.&#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>Analiz Rodriguez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UAMS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <results_first_submitted>May 12, 2023</results_first_submitted>
  <results_first_submitted_qc>July 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2023</results_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 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>Neoplasm Metastasis</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 2, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04422639/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm I (Pre-operative SRS/SRT)</title>
          <description>Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
        </group>
        <group group_id="P2">
          <title>Arm II (Post-operative SRS/SRT)</title>
          <description>Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>study closed prior to completion of FU visits</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm I (Pre-operative SRS/SRT)</title>
          <description>Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
        </group>
        <group group_id="B2">
          <title>Arm II (Post-operative SRS/SRT)</title>
          <description>Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="3"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Central Nervous System (CNS) Composite Event (CE)</title>
        <description>A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).</description>
        <time_frame>From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.</time_frame>
        <population>No data displayed because Outcome Measure has zero total participants analyzed due to low enrollment and early study termination. Study closed prior to completion of follow-up visits so there is nothing to analyze.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Pre-operative SRS/SRT)</title>
            <description>Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Post-operative SRS/SRT)</title>
            <description>Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Central Nervous System (CNS) Composite Event (CE)</title>
          <description>A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).</description>
          <population>No data displayed because Outcome Measure has zero total participants analyzed due to low enrollment and early study termination. Study closed prior to completion of follow-up visits so there is nothing to analyze.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm I (Pre-operative SRS/SRT)</title>
          <description>Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
        </group>
        <group group_id="E2">
          <title>Arm II (Post-operative SRS/SRT)</title>
          <description>Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.&#xD;
SRS/SRT: Comparing pre-operative SRS/SRT to post-operative SRS/SRT</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Left hemiplegia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision decrease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle weakness upper limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Muscle cramp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Edema cerebral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Outcome measures not computed because study closed prior to completion of follow-up visits so there is nothing to analyze.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Assistant Director of Cancer Clinical Trials</name_or_title>
      <organization>University of Arkansas for Medical Sciences</organization>
      <phone>501-686-8274</phone>
      <email>bscanlan@uams.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04422639
org study id: 260505
nct id: NCT04422639
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial
      conducted at a single study site (UAMS). Subjects will be randomized to one of the 2
      treatment arms and stratified by size of index lesion and number of brain metastases.

      The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to
      postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain
      metastases.

      The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain
      metastases will result in improved freedom from Central Nervous System (CNS) events when
      compared to adjuvant SRS/SRT after surgical resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Central Nervous System (CNS) Composite Event (CE)
time frame: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.
description: A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).
arm group label: Arm I (pre-operative SRS/SRT)
arm group type: Experimental
description: Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.
arm group label: Arm II (post-operative SRS/SRT)
arm group type: Active Comparator
description: Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.
intervention type: Radiation
intervention name: SRS/SRT
description: Comparing pre-operative SRS/SRT to post-operative SRS/SRT
arm group label: Arm I (pre-operative SRS/SRT)
arm group label: Arm II (post-operative SRS/SRT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Analiz Rodriguez, MD, PhD
role: Principal Investigator
affiliation: UAMS
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Outcome measures not computed because study closed prior to completion of follow-up visits so there is nothing to analyze.
point of contact: 