xml: <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/NCT06036706</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A02097-36</org_study_id>
      <nct_id>NCT06036706</nct_id>
    </id_info>
    <brief_title>Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:</brief_title>
    <acronym>CANCER-COG</acronym>
    <official_title>Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: A Prospective Multi-Arm Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Francois Baclesse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Région Normandie</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Francois Baclesse</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        For the purpose of this research, investigator will constitute several cohorts of patients,&#xD;
        treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or&#xD;
        proton-therapy. This will allow better understanding the cognitive and anatomical damages&#xD;
        caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays&#xD;
        or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal,&#xD;
        based on yearly multi-parametric brain MRI to assess morphological changes, in relation with&#xD;
        dosimetric data as well as neuropsychological performances, health-related quality of life,&#xD;
        anxiety and depression disorders, memory tasks, and socio-professional reintegration. This&#xD;
        will notably make it possible to evaluate the relationship between dosimetric data, age at&#xD;
        the time of treatment, region of the brain irradiated, type of radiation used, dose per&#xD;
        fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control&#xD;
        Probability (NTCP) model will be also developed. Overall, the results of this study should&#xD;
        contribute to the improvement of treatment techniques, in particular by preserving as much as&#xD;
        possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones,&#xD;
        etc.), and to the management of patients by proposing appropriate support measures. In the&#xD;
        proton-therapy cohort, evaluations will make it possible to establish more precisely the&#xD;
        place that this new irradiation strategy should occupy in the management of low grade&#xD;
        meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects&#xD;
        free of any neurological disease, to make it easier the interpretation of cognitive&#xD;
        performances over time among patients in the three brain radiation cohorts.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 13, 2023</start_date>
    <completion_date type="Anticipated">June 2039</completion_date>
    <primary_completion_date type="Anticipated">September 2038</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of cognitive impairment (a total of ≥ 5 impaired z-scores)</measure>
      <time_frame>10 years</time_frame>
      <description>Occurrence of cognitive impairment in comparison with baseline evaluation (before brain irradiation), evaluated with z-scores</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Meningioma</condition>
    <condition>Radiation Toxicity</condition>
    <arm_group>
      <arm_group_label>Cohort &quot;IMRT&quot;:</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort &quot;SRT&quot;</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients receiving hypo-fractionated stereotactic brain irradiation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort &quot;PRT&quot;</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients receiving normo-fractionated proton therapy brain irradiation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants without any meningioma, cancer history or neurological comorbidities</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning</intervention_name>
      <description>Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)</description>
      <arm_group_label>Cohort &quot;IMRT&quot;:</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Hypo-fractionated stereotactic brain irradiation</intervention_name>
      <description>Patients receiving hypo-fractionated stereotactic brain irradiation</description>
      <arm_group_label>Cohort &quot;SRT&quot;</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Normo-fractionated proton therapy brain irradiation</intervention_name>
      <description>Patients receiving normo-fractionated proton therapy brain irradiation</description>
      <arm_group_label>Cohort &quot;PRT&quot;</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cognitive assessment by a trained neuropsychologis</intervention_name>
      <description>Participants without any meningioma, cancer history or neurological comorbidities will undergo cognitive assessment by a trained neuropsychologist, similarly as for patients</description>
      <arm_group_label>Control cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Patients:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Benign meningioma (grade I), or atypical meningioma (grade II)&#xD;
  &#xD;
            -  Histologic proven of benign meningioma, atypical meningioma or unequivocal&#xD;
               radiological diagnosis of skull base meningioma if biopsy is recused.&#xD;
  &#xD;
            -  Indication of irradiation validated by a multidisciplinary meeting&#xD;
  &#xD;
            -  Age &gt;20 years and &lt;65 years&#xD;
  &#xD;
            -  Expected overall survival &gt;10 years&#xD;
  &#xD;
            -  Adjuvant or exclusive irradiation is allowed.&#xD;
  &#xD;
            -  Signed informed consent form&#xD;
  &#xD;
            -  WHO Performance status equal to 0 or 1&#xD;
  &#xD;
            -  Patient affiliated to the French social health insurance&#xD;
  &#xD;
            -  Patient whose neuropsychological abilities allow to follow the requirements of the&#xD;
               protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with mutation in a known predisposition gene (NF-2, SMARCE-1).&#xD;
  &#xD;
            -  Cerebrovascular pathology, presence of other tumors of the nervous system, congenital&#xD;
               malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic&#xD;
               psychosis (other than dementia), or schizophrenia.&#xD;
  &#xD;
            -  Other localization than skull base meningioma&#xD;
  &#xD;
            -  Histology/radiological features rather different than grade I-II meningioma&#xD;
  &#xD;
            -  Histologic proven grade III meningioma&#xD;
  &#xD;
            -  History of epilepsy with antiepileptic drug&#xD;
  &#xD;
            -  Contraindication to MRI&#xD;
  &#xD;
            -  Patient with a history of brain irradiation.&#xD;
  &#xD;
            -  Patient with a history of cancer in the last five years (excluding skin baso-cellular&#xD;
               carcinoma)&#xD;
  &#xD;
            -  Pregnant/breastfeeding woman&#xD;
  &#xD;
            -  Any geographical conditions, social and associated psychopathology that may compromise&#xD;
               the patient's ability to participate in the study&#xD;
  &#xD;
            -  Participation in a therapeutic trial evaluating a radiotherapy schedule or a new drug&#xD;
               or combination for less than 30 days&#xD;
  &#xD;
            -  Patient deprived of freedom or under guardianship&#xD;
  &#xD;
            -  Hypersensibility to Gadolinium&#xD;
  &#xD;
          Participants free of brain disease or cancer history:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject without any history of neurological disease (cerebral stroke, epilepsy, Intra&#xD;
               cranial Neurosurgery procedure, meningioma, pituitary adenoma, Parkinson&#xD;
               disease,Dementia…) or absence of personality disorders and progressive psychiatric&#xD;
               pathology&#xD;
  &#xD;
            -  Age &gt;20 years and &lt;65 years&#xD;
  &#xD;
            -  Signed informed consent form&#xD;
  &#xD;
            -  WHO Performance status equal to 0 or 1&#xD;
  &#xD;
            -  Subject affiliated to the French social health insurance&#xD;
  &#xD;
            -  Subject whose neuropsychological abilities allow to follow the requirements of the&#xD;
               protocol&#xD;
  &#xD;
            -  No major cognitive disorder that may compromise the realization of cognitive&#xD;
               evaluations, defined as a MoCA score in accordance with the threshold depending on age&#xD;
               and educational level according to the GRECOGVASC normative data&#xD;
  &#xD;
          Non-inclusion criteria&#xD;
  &#xD;
            -  Cerebrovascular pathology, presence of other tumors of the nervous system, congenital&#xD;
               malformations of the nervous system, multiple sclerosis, Parkinson's disease, organic&#xD;
               psychosis (other than dementia), or schizophrenia&#xD;
  &#xD;
            -  History of epilepsy with antiepileptic drug&#xD;
  &#xD;
            -  Subject with a history of brain irradiation&#xD;
  &#xD;
            -  Subject with a history of cancer in the last five years (Excluding skin baso-cellular&#xD;
               carcinoma)&#xD;
  &#xD;
            -  Pregnant/breastfeeding woman&#xD;
  &#xD;
            -  Any geographical conditions, social and associated psychopathology that may compromise&#xD;
               the subject's ability to participate in the study&#xD;
  &#xD;
            -  Participation in a therapeutic trial - Subject deprived of freedom or under&#xD;
               guardianship&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Paul LESUEUR, MD</last_name>
      <phone>+33 2 31 45 50 50</phone>
      <email>p.lesueur@baclesse.unicancer.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jean-Michel GRELLARD</last_name>
      <phone>+33 2 31 45 50 50</phone>
      <email>jm.grellard@baclesse.unicancer.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>centre François Baclesse</name>
        <address>
          <city>Caen</city>
          <zip>14000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Paul LESUEUR, MD</last_name>
      </contact>
      <investigator>
        <last_name>Paul LESUEUR, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dinu STEFAN, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Julien GEFFRELOT, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Henri Becquerel</name>
        <address>
          <city>Rouen</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sébastien THUREAU, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Sébastien THUREAU, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ovidiu VERESEZAN, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 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>Meningioma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036706
  org study id: 2022-A02097-36
  nct id: NCT06036706
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  For the purpose of this research, investigator will constitute several cohorts of patients,
        treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or
        proton-therapy. This will allow better understanding the cognitive and anatomical damages
        caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays
        or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal,
        based on yearly multi-parametric brain MRI to assess morphological changes, in relation with
        dosimetric data as well as neuropsychological performances, health-related quality of life,
        anxiety and depression disorders, memory tasks, and socio-professional reintegration. This
        will notably make it possible to evaluate the relationship between dosimetric data, age at
        the time of treatment, region of the brain irradiated, type of radiation used, dose per
        fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control
        Probability (NTCP) model will be also developed. Overall, the results of this study should
        contribute to the improvement of treatment techniques, in particular by preserving as much as
        possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones,
        etc.), and to the management of patients by proposing appropriate support measures. In the
        proton-therapy cohort, evaluations will make it possible to establish more precisely the
        place that this new irradiation strategy should occupy in the management of low grade
        meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects
        free of any neurological disease, to make it easier the interpretation of cognitive
        performances over time among patients in the three brain radiation cohorts.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Occurrence of cognitive impairment (a total of ≥ 5 impaired z-scores)
  time frame: 10 years
  description: Occurrence of cognitive impairment in comparison with baseline evaluation (before brain irradiation), evaluated with z-scores
  arm group label: Cohort "IMRT":
  arm group type: Other
  description: Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)
  arm group label: Cohort "SRT"
  arm group type: Other
  description: Patients receiving hypo-fractionated stereotactic brain irradiation
  arm group label: Cohort "PRT"
  arm group type: Other
  description: Patients receiving normo-fractionated proton therapy brain irradiation
  arm group label: Control cohort
  arm group type: Other
  description: Participants without any meningioma, cancer history or neurological comorbidities
  intervention type: Radiation
  intervention name: Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning
  description: Patients receiving normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning (IMRT, VMAT, Tomotherapy…)
  arm group label: Cohort "IMRT":
  intervention type: Radiation
  intervention name: Hypo-fractionated stereotactic brain irradiation
  description: Patients receiving hypo-fractionated stereotactic brain irradiation
  arm group label: Cohort "SRT"
  intervention type: Radiation
  intervention name: Normo-fractionated proton therapy brain irradiation
  description: Patients receiving normo-fractionated proton therapy brain irradiation
  arm group label: Cohort "PRT"
  intervention type: Other
  intervention name: Cognitive assessment by a trained neuropsychologis
  description: Participants without any meningioma, cancer history or neurological comorbidities will undergo cognitive assessment by a trained neuropsychologist, similarly as for patients
  arm group label: Control cohort
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Paul LESUEUR, MD
  phone: +33 2 31 45 50 50
  email: p.lesueur@baclesse.unicancer.fr
  last name: Jean-Michel GRELLARD
  phone: +33 2 31 45 50 50
  email: jm.grellard@baclesse.unicancer.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Meningioma