<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/NCT02973256</url>
  </required_header>
  <id_info>
    <org_study_id>UF9759</org_study_id>
    <nct_id>NCT02973256</nct_id>
  </id_info>
  <brief_title>Oncological Care for Patients With Meningioma</brief_title>
  <acronym>ATYPICMENING</acronym>
  <official_title>Postoperative Oncological Care for Patients With Meningioma With Malignant Components</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Meningiomas with malignant components include grade II meningiomas (GIIM, the most common&#xD;
      ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas.&#xD;
      Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as&#xD;
      being quite subjective. &quot;Standards of care&quot; and consensus do not exist for GIIM, particularly&#xD;
      in regards to performing, or not, radiotherapy after surgery. One other limitation in the&#xD;
      literature is lack of data on health-related quality of life (HRQoL). Clinical trials for&#xD;
      GIIM are very difficult to conduct. No results have been made available. Here, we propose to&#xD;
      study clinical, pathological, radiological and therapeutic factors of an exhaustive&#xD;
      population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to&#xD;
      assess the impact of postoperative radiotherapy, or the absence of postoperative&#xD;
      radiotherapy, on overall survival and on quality of life&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Meningiomas with malignant components include grade II meningiomas (GIIM, the most common&#xD;
      ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas.&#xD;
      Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as&#xD;
      being quite subjective. &quot;Standards of care&quot; and consensus do not exist for GIIM, particularly&#xD;
      in regards to performing, or not, radiotherapy after surgery. One other limitation in the&#xD;
      literature is lack of data on health-related quality of life (HRQoL). Clinical trials for&#xD;
      GIIM are very difficult to conduct. No results have been made available.&#xD;
&#xD;
      Main objective: to assess the impact of postoperative radiotherapy after GIIM surgery on&#xD;
      overall survival (OS) in a population-setting study.&#xD;
&#xD;
      Secondary objectives (for GIIM and GIIIM):&#xD;
&#xD;
        -  Evaluate the recurrence/progression free survival (PFS), volumetric velocity of the&#xD;
           tumor growth (VVTG) after surgery and other treatment.&#xD;
&#xD;
        -  Evaluate long term HRQoL.&#xD;
&#xD;
        -  Evaluate the relevance and impact of histopathological review in a population setting.&#xD;
&#xD;
        -  Looking for prognostic (clinical, radiological and biological) factors.&#xD;
&#xD;
        -  Proposing therapeutic decision trees in general or for certain categories of patients.&#xD;
&#xD;
        -  Identifying relevant cases to conduct further studies to identify new therapeutic&#xD;
           targets.&#xD;
&#xD;
        -  Perspectives for the TUCERA network to help design specific prospective projects.&#xD;
&#xD;
        -  Looking for disparities in care management, survival and HRQoL in the various regions of&#xD;
           France.&#xD;
&#xD;
      Design of the study: nationwide population-based study analysis and patterns of care/quality&#xD;
      of care study, for all cases of incident GIIM and GIIIM operated in Metropolitan France&#xD;
      during the 2007-2010 period.&#xD;
&#xD;
      The methodology used is based on a multidisciplinary national network already established by&#xD;
      the French Brain Tumor DataBase (FBTDB), with the active participation of societies involved&#xD;
      in the French neuro-oncology and the &quot;Inter Groupe Coopérateur en Neuro-Oncologie&quot;, labeled&#xD;
      by the French National Cancer Institute.&#xD;
&#xD;
      The FBTDB has already identified all incident cases of GIIM (n=1046) and GIIIM (n=158)&#xD;
      operated in Metropolitan France from 2007 to 2010.&#xD;
&#xD;
      The study proposed is a retrospective study based on the medical charts of all these&#xD;
      patients.&#xD;
&#xD;
      Furthermore, for all surviving patients not lost to follow-up, the follow-up consultations&#xD;
      will include a prospective HRQoL evaluation (cutoff date: 2019/11/30).&#xD;
&#xD;
      It will be conducted a systematic pathological review (with eventually additional biological&#xD;
      work-up), and a study of prognostic factors (clinical, radiological, biological), treatments&#xD;
      administered, OS, PFS.&#xD;
&#xD;
      Primary endpoint: OS. The statistical analysis (to answer to the main question) will concern&#xD;
      all GIIM only.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Experimental group: Group of GIIM with postoperative radiotherapy (n=314). Control group:&#xD;
      Group of GIIM with postoperative follow-up only (n=732). With a bilateral type I error of 5%&#xD;
      (two-sided) and a statistical power of 80% we will be able to demonstrate that postoperative&#xD;
      radiotherapy will be associated with a Hazard ratio (mortality risk) of 0.80.&#xD;
&#xD;
      Secondary endpoints (for GIIM and GIIIM):&#xD;
&#xD;
        -  PFS, VVTG after surgery and other treatment.&#xD;
&#xD;
        -  HRQoL will be assessed using EORTC QLQ-C30, BN20 questionnaires, Europol EQ5D, and with&#xD;
           a questionnaire on professional and social activities (HRQoL will be assessed for all&#xD;
           patients alive, every six months, since inclusion, for an 18-month period).&#xD;
&#xD;
        -  Mapping between HRQoL questionnaires.&#xD;
&#xD;
        -  Concordance/discordance analysis between the initial histological diagnosis and the&#xD;
           diagnosis of the pathological review.&#xD;
&#xD;
        -  Conduct an inventory of cryopreserved material available for translational research.&#xD;
&#xD;
      It is expected to:&#xD;
&#xD;
        -  Define subgroups of patients, according to prognostic factors, which would benefit from&#xD;
           postoperative radiotherapy in GIIM.&#xD;
&#xD;
        -  Define subgroups of patients, according to their prognostic factors, which would benefit&#xD;
           from not having postoperative radiotherapy in GIIM.&#xD;
&#xD;
        -  Propose personalized therapeutic attitudes according to prognostic factors (clinical,&#xD;
           radiological, and biological) in general, but also for specific categories of patients&#xD;
           such as elderly subjects.&#xD;
&#xD;
        -  Define subgroups of GIIM and GIIIM that will justify conducting trials in the framework&#xD;
           of the TUCERA network.&#xD;
&#xD;
        -  Evaluate in population settings, the relevance and impact of a systematic&#xD;
           histopathological review.&#xD;
&#xD;
        -  Develop HRQoL evaluation in population settings.&#xD;
&#xD;
        -  Acquire better knowledge of prognostic factors (clinical, radiological and biological)&#xD;
           for GIIM and GIIIM, their natural history, and maybe help determine elements able to&#xD;
           differentiate GIIM that will progress to GIIIM, from those that will remain GIIM.&#xD;
&#xD;
        -  Build a clinical-biological database to identify and/or develop new therapeutic targets&#xD;
           in GIIM and GIIIM.&#xD;
&#xD;
        -  Evaluate potential disparities in terms of survival and HRQoL in the different French&#xD;
           regions, and if some disparities are found, look for eventual causes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>up to 10 years, since diagnosis</time_frame>
    <description>Description: Assessing the impact of postoperative radiotherapy after surgery on overall survival (OS) in population-based study of GIIM patients. Overall survival, the primary endpoint of this study, is defined as the time from surgery (histological diagnosis) to the time of death from any cause. Alive Patients at the time of the final analysis or who became lost to follow-up will be censored at their last date of giving news</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the tumor growth</measure>
    <time_frame>up to 10 years, since diagnosis</time_frame>
    <description>The tumor growth after surgery and other treatment (based on successive MRIs) will be determined by the volumetric velocity of the tumor growth (mm3/year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression/Recurrence Free Survival, will be measured by month</measure>
    <time_frame>up to 10 years, since diagnosis</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of the quality of life</measure>
    <time_frame>baseline, 6 months, 12 months 18 months</time_frame>
    <description>Change from baseline in patients with a I and II grade glioma, defined by quality-of-life parameters Health related Quality of Life will be assessed using EORTC QlQ C30 and BN 20 questionnaires, Europol EQ5D, and a specific questionnaire on professional and social activities.&#xD;
-EORTC QLQ-C30: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint&#xD;
-EORTC QLQ-BN20: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint&#xD;
Europol EQ5D Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint&#xD;
Specific questionnaire on professional and social activities:&#xD;
Score at baseline, The change in the Specific questionnaire on professional and social activities score from baseline to endpoint</description>
  </other_outcome>
  <other_outcome>
    <measure>diagnosis of the central pathological review.</measure>
    <time_frame>1 day</time_frame>
    <description>Concordance/discordance analysis between the initial histological diagnosis and the diagnosis of the central pathological review.</description>
  </other_outcome>
  <enrollment type="Anticipated">1204</enrollment>
  <condition>Atypical Meningioma</condition>
  <condition>Clear-cell Meningioma</condition>
  <condition>Chordoid Meningioma</condition>
  <condition>Anaplastic Meningioma</condition>
  <condition>Rhabdoid Meningioma</condition>
  <condition>Papillary Meningioma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a histological diagnosis of GIIM and GIIIM in metropolitan France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria :Patient with a GIIM incident (atypical, chordidic and clear cell&#xD;
        meningiomas) and GIIIM (anaplastic, papillary and rhabdoid meningiomas) operated in&#xD;
        metropolitan France during the period 2007-2010&#xD;
&#xD;
        Exclusion Criteria :&#xD;
&#xD;
          -  Patient with GIM&#xD;
&#xD;
          -  Non-operated meningioma patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LUC BAUCHET, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UH MONTPELLIER</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>LUC BAUCHET, MD, PhD</last_name>
    <phone>467337205</phone>
    <phone_ext>33</phone_ext>
    <email>l-bauchet@chu-montpellier.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Frank BONNETAIN</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uh Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LUC BAUCHET, MD, PhD</last_name>
      <phone>467337205</phone>
      <phone_ext>33</phone_ext>
      <email>l-bauchet@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningioma grade II</keyword>
  <keyword>Meningioma grade III</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/NCT02973256
org study id: UF9759
nct id: NCT02973256
lead sponsor: 
collaborator: 
has dmc: Yes
Meningiomas with malignant components include grade II meningiomas (GIIM, the most common
      ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas.
      Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as
      being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly
      in regards to performing, or not, radiotherapy after surgery. One other limitation in the
      literature is lack of data on health-related quality of life (HRQoL). Clinical trials for
      GIIM are very difficult to conduct. No results have been made available. Here, we propose to
      study clinical, pathological, radiological and therapeutic factors of an exhaustive
      population of GIIM and GIIIM patients, at national level. The main objective (for GIIM) is to
      assess the impact of postoperative radiotherapy, or the absence of postoperative
      radiotherapy, on overall survival and on quality of life
Meningiomas with malignant components include grade II meningiomas (GIIM, the most common
      ones) and grade III meningiomas (GIIIM). They represent 5-35% of all meningiomas.
      Histological diagnosis of GIIM criteria were changed in 2007 and might be viewed by some as
      being quite subjective. "Standards of care" and consensus do not exist for GIIM, particularly
      in regards to performing, or not, radiotherapy after surgery. One other limitation in the
      literature is lack of data on health-related quality of life (HRQoL). Clinical trials for
      GIIM are very difficult to conduct. No results have been made available.

      Main objective: to assess the impact of postoperative radiotherapy after GIIM surgery on
      overall survival (OS) in a population-setting study.

      Secondary objectives (for GIIM and GIIIM):

        -  Evaluate the recurrence/progression free survival (PFS), volumetric velocity of the
           tumor growth (VVTG) after surgery and other treatment.

        -  Evaluate long term HRQoL.

        -  Evaluate the relevance and impact of histopathological review in a population setting.

        -  Looking for prognostic (clinical, radiological and biological) factors.

        -  Proposing therapeutic decision trees in general or for certain categories of patients.

        -  Identifying relevant cases to conduct further studies to identify new therapeutic
           targets.

        -  Perspectives for the TUCERA network to help design specific prospective projects.

        -  Looking for disparities in care management, survival and HRQoL in the various regions of
           France.

      Design of the study: nationwide population-based study analysis and patterns of care/quality
      of care study, for all cases of incident GIIM and GIIIM operated in Metropolitan France
      during the 2007-2010 period.

      The methodology used is based on a multidisciplinary national network already established by
      the French Brain Tumor DataBase (FBTDB), with the active participation of societies involved
      in the French neuro-oncology and the "Inter Groupe Coopérateur en Neuro-Oncologie", labeled
      by the French National Cancer Institute.

      The FBTDB has already identified all incident cases of GIIM (n=1046) and GIIIM (n=158)
      operated in Metropolitan France from 2007 to 2010.

      The study proposed is a retrospective study based on the medical charts of all these
      patients.

      Furthermore, for all surviving patients not lost to follow-up, the follow-up consultations
      will include a prospective HRQoL evaluation (cutoff date: 2019/11/30).

      It will be conducted a systematic pathological review (with eventually additional biological
      work-up), and a study of prognostic factors (clinical, radiological, biological), treatments
      administered, OS, PFS.

      Primary endpoint: OS. The statistical analysis (to answer to the main question) will concern
      all GIIM only.

      Hypothesis:

      Experimental group: Group of GIIM with postoperative radiotherapy (n=314). Control group:
      Group of GIIM with postoperative follow-up only (n=732). With a bilateral type I error of 5%
      (two-sided) and a statistical power of 80% we will be able to demonstrate that postoperative
      radiotherapy will be associated with a Hazard ratio (mortality risk) of 0.80.

      Secondary endpoints (for GIIM and GIIIM):

        -  PFS, VVTG after surgery and other treatment.

        -  HRQoL will be assessed using EORTC QLQ-C30, BN20 questionnaires, Europol EQ5D, and with
           a questionnaire on professional and social activities (HRQoL will be assessed for all
           patients alive, every six months, since inclusion, for an 18-month period).

        -  Mapping between HRQoL questionnaires.

        -  Concordance/discordance analysis between the initial histological diagnosis and the
           diagnosis of the pathological review.

        -  Conduct an inventory of cryopreserved material available for translational research.

      It is expected to:

        -  Define subgroups of patients, according to prognostic factors, which would benefit from
           postoperative radiotherapy in GIIM.

        -  Define subgroups of patients, according to their prognostic factors, which would benefit
           from not having postoperative radiotherapy in GIIM.

        -  Propose personalized therapeutic attitudes according to prognostic factors (clinical,
           radiological, and biological) in general, but also for specific categories of patients
           such as elderly subjects.

        -  Define subgroups of GIIM and GIIIM that will justify conducting trials in the framework
           of the TUCERA network.

        -  Evaluate in population settings, the relevance and impact of a systematic
           histopathological review.

        -  Develop HRQoL evaluation in population settings.

        -  Acquire better knowledge of prognostic factors (clinical, radiological and biological)
           for GIIM and GIIIM, their natural history, and maybe help determine elements able to
           differentiate GIIM that will progress to GIIIM, from those that will remain GIIM.

        -  Build a clinical-biological database to identify and/or develop new therapeutic targets
           in GIIM and GIIIM.

        -  Evaluate potential disparities in terms of survival and HRQoL in the different French
           regions, and if some disparities are found, look for eventual causes.
observational model: Case-Only
time perspective: Prospective
measure: overall survival
time frame: up to 10 years, since diagnosis
description: Description: Assessing the impact of postoperative radiotherapy after surgery on overall survival (OS) in population-based study of GIIM patients. Overall survival, the primary endpoint of this study, is defined as the time from surgery (histological diagnosis) to the time of death from any cause. Alive Patients at the time of the final analysis or who became lost to follow-up will be censored at their last date of giving news
measure: the tumor growth
time frame: up to 10 years, since diagnosis
description: The tumor growth after surgery and other treatment (based on successive MRIs) will be determined by the volumetric velocity of the tumor growth (mm3/year)
measure: Progression/Recurrence Free Survival, will be measured by month
time frame: up to 10 years, since diagnosis
measure: Evaluation of the quality of life
time frame: baseline, 6 months, 12 months 18 months
description: Change from baseline in patients with a I and II grade glioma, defined by quality-of-life parameters Health related Quality of Life will be assessed using EORTC QlQ C30 and BN 20 questionnaires, Europol EQ5D, and a specific questionnaire on professional and social activities.
-EORTC QLQ-C30: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint
-EORTC QLQ-BN20: Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint
Europol EQ5D Score at baseline, The change in the EORTC QLQ-C30 score from baseline to endpoint
Specific questionnaire on professional and social activities:
Score at baseline, The change in the Specific questionnaire on professional and social activities score from baseline to endpoint
measure: diagnosis of the central pathological review.
time frame: 1 day
description: Concordance/discordance analysis between the initial histological diagnosis and the diagnosis of the central pathological review.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: LUC BAUCHET, MD, PhD
role: Study Director
affiliation: UH MONTPELLIER
last name: LUC BAUCHET, MD, PhD
phone: 467337205
phone ext: 33
email: l-bauchet@chu-montpellier.fr
last name: Frank BONNETAIN
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Meningioma
sharing ipd: Undecided