<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/NCT02974127</url>
  </required_header>
  <id_info>
    <org_study_id>SRS_LM</org_study_id>
    <nct_id>NCT02974127</nct_id>
  </id_info>
  <brief_title>Multisession Radiosurgery in Large Meningiomas</brief_title>
  <acronym>MuRaLM</acronym>
  <official_title>Multisession Radiosurgery in Large Meningiomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective observational trial consisting of robotic multisession radiosurgery&#xD;
      (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial&#xD;
      meningiomas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To date, the treatment of choice for intracranial meningiomas is surgical removal.&#xD;
&#xD;
      Radiotherapy, especially the radiosurgery (SRS), in exclusive, adjuvant or salvage setting&#xD;
      represents an alternative or complementary viable treatment to the neurosurgery. Despite&#xD;
      being a well-established treatment for intracranial meningiomas, SRS might be associated with&#xD;
      significant morbidity when large volumes or critical sites are treated. Hypofractionated&#xD;
      stereotactic radiotherapy has the potential to deliver sharply focused high doses per&#xD;
      fraction without increasing the risk of toxicity.&#xD;
&#xD;
      The aims of our study are toxicity and symptom control evaluation of radiosurgery treatment&#xD;
      delivered in multisession, for large or medium size intracranial meningiomas and/or for&#xD;
      intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area,&#xD;
      PCA). We will evaluate also the efficacy of the treatment by volumetric analysis of treated&#xD;
      meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment&#xD;
      (every 6 month after treatment).&#xD;
&#xD;
      The neurological and clinical assessment before and after s-SRS will be based on CTCAE v4.0&#xD;
      and BPN BSN House-Brackman and sensorineural internation scale assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 2011</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation-related toxicities.</measure>
    <time_frame>change from baseline neurological assessment at 5 years.</time_frame>
    <description>evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Local control evaluation assessed on MRI-based volumetric lesion measurements.</measure>
    <time_frame>change from baseline volume lesion at 5 years</time_frame>
    <description>Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurological assessment of trigeminal pain</measure>
    <time_frame>every 6 months, up to 3 years. Afterwards, every year up to 5 years.</time_frame>
    <description>Evaluation based on BNP scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological assessment of trigeminal dysfunction</measure>
    <time_frame>every 6 months, up to 3 years. Afterwards, every year up to 5 years.</time_frame>
    <description>Evaluation based on BNS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological assessment of facial nerve dysfunction</measure>
    <time_frame>every 6 months, up to 3 years. Afterwards, every year up to 5 years.</time_frame>
    <description>Evaluation based on House-Brackman scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological assessment of acoustic nerve dysfunction</measure>
    <time_frame>every 6 months, up to 3 years. Afterwards, every year up to 5 years.</time_frame>
    <description>Evaluation based on sensorineural international scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological assessment of visual dysfunction</measure>
    <time_frame>every 6 months, up to 3 years. Afterwards, every year up to 5 years.</time_frame>
    <description>Evaluation based on ophthalmological evaluation</description>
  </secondary_outcome>
  <enrollment type="Anticipated">178</enrollment>
  <condition>Intracranial Meningioma</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Multisession radiosurgery</description>
    <other_name>Radiosurgery</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with large or in critical site benign intracranial meningioma diagnosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  either histologically confirmed or imaging-defined benign meningioma diagnosis;&#xD;
&#xD;
          -  large or medium lesion size and/or in critical area (e.i. perichiasmatic area);&#xD;
&#xD;
          -  signed specific informed consent;&#xD;
&#xD;
          -  age ≥ 18 years;&#xD;
&#xD;
          -  for female patients, execution of pregnancy blood test;&#xD;
&#xD;
          -  Karnofsky Performance Status (KPS) ≥ 70.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed diagnosis of atypical or malignant meningiomas;&#xD;
&#xD;
          -  patients who had received prior radiotherapy in the same site;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  allergy for contrast medium;&#xD;
&#xD;
          -  neurofibromatosis diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Fariselli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Neurologico Carlo BEsta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Neurologico C. Besta, Unit of Radiotherapy</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intracranial benign meningioma</keyword>
  <keyword>radiosurgery</keyword>
  <keyword>large meningioma</keyword>
  <keyword>critical site</keyword>
  <keyword>multisession radiosurgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningioma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02974127
org study id: SRS_LM
nct id: NCT02974127
lead sponsor: 
has dmc: No
This is a prospective observational trial consisting of robotic multisession radiosurgery
      (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial
      meningiomas.
To date, the treatment of choice for intracranial meningiomas is surgical removal.

      Radiotherapy, especially the radiosurgery (SRS), in exclusive, adjuvant or salvage setting
      represents an alternative or complementary viable treatment to the neurosurgery. Despite
      being a well-established treatment for intracranial meningiomas, SRS might be associated with
      significant morbidity when large volumes or critical sites are treated. Hypofractionated
      stereotactic radiotherapy has the potential to deliver sharply focused high doses per
      fraction without increasing the risk of toxicity.

      The aims of our study are toxicity and symptom control evaluation of radiosurgery treatment
      delivered in multisession, for large or medium size intracranial meningiomas and/or for
      intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area,
      PCA). We will evaluate also the efficacy of the treatment by volumetric analysis of treated
      meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment
      (every 6 month after treatment).

      The neurological and clinical assessment before and after s-SRS will be based on CTCAE v4.0
      and BPN BSN House-Brackman and sensorineural internation scale assessment.
observational model: Cohort
time perspective: Prospective
measure: Radiation-related toxicities.
time frame: change from baseline neurological assessment at 5 years.
description: evaluation every 6 months, up to 3 years. Afterwards, every year up to 5 years based on CTCAE v4.0
measure: Local control evaluation assessed on MRI-based volumetric lesion measurements.
time frame: change from baseline volume lesion at 5 years
description: Evaluation based on 1-3 mm thickness T1 weighted (or volumetric FAT saturation weighted) brain gadolinium-MRI images
measure: Neurological assessment of trigeminal pain
time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
description: Evaluation based on BNP scale
measure: Neurological assessment of trigeminal dysfunction
time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
description: Evaluation based on BNS scale
measure: Neurological assessment of facial nerve dysfunction
time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
description: Evaluation based on House-Brackman scale
measure: Neurological assessment of acoustic nerve dysfunction
time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
description: Evaluation based on sensorineural international scale
measure: Neurological assessment of visual dysfunction
time frame: every 6 months, up to 3 years. Afterwards, every year up to 5 years.
description: Evaluation based on ophthalmological evaluation
intervention type: Radiation
intervention name: Radiotherapy
description: Multisession radiosurgery
other name: Radiosurgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Laura Fariselli, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Neurologico Carlo BEsta
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Meningioma
sharing ipd: Undecided