<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/NCT04452032</url>
  </required_header>
  <id_info>
    <org_study_id>IJB-RT-HNC-002</org_study_id>
    <nct_id>NCT04452032</nct_id>
  </id_info>
  <brief_title>Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer</brief_title>
  <acronym>StomRay</acronym>
  <official_title>Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jules Bordet Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jules Bordet Institute</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>
      Multi-centric, one arm phase II study. The first phase of the study will consist of an&#xD;
      evaluation of the initial dental state of each subject based on a stomatological examination,&#xD;
      an orthopantomogram, two bitewing radiographs (right and left sides) and an evaluation of all&#xD;
      potential risks of caries and fractures. For all of subjects, a dental decalcification,&#xD;
      dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed&#xD;
      before the start of RT treatment. Our previously developed predictive model for dental dose&#xD;
      in function of the localisation of tumour and suspect lymph nodes based on the stomatological&#xD;
      examination and on the pre-treatment imaging. An estimation of the intensity-modulated&#xD;
      radiotherapy (IMRT) teeth dose will be made and translated into a colour based form of the&#xD;
      pre-RT dental status. A contouring of the teeth will be performed and the planned dose for&#xD;
      each tooth of each subject will be recorded by a dose volume histogram (DVH) curve based on&#xD;
      the pre-treatment imaging. In the same way the mean dose and the V25 (the volume receiving 25&#xD;
      Gy) of the homo- and the heterolateral parotid gland will be calculated. Based on our&#xD;
      predictive model, every tooth which potentially will receive more than 40 Gy and for which&#xD;
      long term survival is compromised will be avulsed at least 2 weeks before the start of RT.&#xD;
&#xD;
      After RT, the subject will have clinical follow-up with dental evaluation every 6 months for&#xD;
      36 months in order to identify possible dental events. At each consultation, a stomatological&#xD;
      examination will be performed as well as two bitewing radiographs. An orthopantomogram will&#xD;
      be done once a year. Furthermore, periapical X-rays will be performed if there is a dental&#xD;
      complain or to refine a lesion visible on orthopantomogram.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 17, 2020</start_date>
  <completion_date type="Anticipated">May 16, 2027</completion_date>
  <primary_completion_date type="Anticipated">May 16, 2026</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of dental complication</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Frequency of dental fractures according to the teeth radiotherapy delivered dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk of dental complication</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Frequency of dental caries according to the parotid radiotherapy delivered dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validation of a &quot;predictive dose model&quot; of radiotherapy</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Predictive dose of radiotherapy according to the location of the tumour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation of a &quot;predictive dose model&quot; of radiotherapy</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Predictive dose of radiotherapy according to the TNM stage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Validation of a &quot;predictive dose model&quot; of radiotherapy</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Predictive dose of radiotherapy with the real dose of radiotherapy received</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the predictive dose of radiotherapy with the dental complication probability</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Number of dental caries per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the predictive dose of radiotherapy with the dental complication probability</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Number of dental fractures per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the predictive dose of radiotherapy with the dental complication probability</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Number of dental avulsions per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Avulsion-free</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Number of patients who developp an osteoradionecrosis of the jaw</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Outcome measure: completion of xerostomia questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Outcome measure: completion of EORTC: QLQ-C30 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Quality of life</measure>
    <time_frame>At 36 months after end of radiotherapy</time_frame>
    <description>Outcome measure: completion of EORTC: QLQ-H&amp;N43 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Head and Neck Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first phase of the study will consist of an evaluation of the initial dental state of each subject based on stomatological examination, orthopantomogram, bitewing radiographs, evaluation of potential risks of caries and fractures. Dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment.Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT.&#xD;
After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as bitewing radiographs. Orthopantomogram will be done once a year. Periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dental avulsion</intervention_name>
    <description>Before radiotherapy, each subject undergoes a dental evaluation and if it is necessary, dental avulsions if their long-term survival is compromised (see in section 6.1.2) and if they are located in an area at risk to receive more than 40 Gy, so to develop osteoradionecrosis of the jaw. The avulsions should be performed as far as possible from the start of radiotherapy (RT) namely at least 2 weeks before irradiation to allow mucosal healing.</description>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>Radiotherapy:&#xD;
All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT).</description>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years old&#xD;
&#xD;
          2. ECOG performance status ≤2&#xD;
&#xD;
          3. Female and Male&#xD;
&#xD;
          4. Newly diagnosed, histologically or cytologically confirmed head and neck squamous cell&#xD;
             carcinoma (oropharynx, oral cavity, larynx, hypopharynx or cavum)&#xD;
&#xD;
          5. Results of previous pre-treatment imaging (PET-CT and cervicofacial MRI and/or&#xD;
             CT/scan)&#xD;
&#xD;
          6. Eligible for treatment based on (chemo-)radiotherapy (with or without a surgical&#xD;
             treatment)&#xD;
&#xD;
          7. Agree to wear, three times per week, fluoride dental splint after RT&#xD;
&#xD;
          8. HPV/p 16 testing results available at the time of screening (only for subjects with&#xD;
             oropharynx cancer)&#xD;
&#xD;
          9. Serum pregnancy test (for subjects of childbearing potential) negative within 7 days&#xD;
             prior to the 1st radiotherapy treatment&#xD;
&#xD;
         10. Women of childbearing potential must agree to use of one effective method of&#xD;
             contraception prior study entry and during the course of the study.&#xD;
&#xD;
         11. Completion of all necessary screening procedures within 30 days prior to 1st&#xD;
             radiotherapy treatment.&#xD;
&#xD;
         12. Signed Informed Consent form (ICF) obtained prior to any study related procedure.&#xD;
&#xD;
         13. Ability to understand and complete the questionnaires (language proficiency, cognitive&#xD;
             functioning) as judged by the principal investigator upon screening&#xD;
&#xD;
        Note: Subject from the SwallPEG trial can participate in the StomRay study if they meet all&#xD;
        of the previous eligibility criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject having less than ten teeth on dental arch&#xD;
&#xD;
          2. Life expectancy less than 12 months&#xD;
&#xD;
          3. History of previous head and neck irradiation&#xD;
&#xD;
          4. Prior or current treatment with bisphosphonates or denosumab&#xD;
&#xD;
          5. Presence of too many metal artefacts on the RT simulation scan preventing precise&#xD;
             teeth contouring&#xD;
&#xD;
          6. Subject with a significant medical, neuro-psychiatric, or surgical condition,&#xD;
             currently uncontrolled by treatment, which, in the principal investigator's opinion,&#xD;
             may interfere with completion of the study.&#xD;
&#xD;
          7. Pregnancy and/or lactating women&#xD;
&#xD;
          8. Subjects with imperfect amelogenesis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU saint Pierre</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 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>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</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/NCT04452032
org study id: IJB-RT-HNC-002
nct id: NCT04452032
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multi-centric, one arm phase II study. The first phase of the study will consist of an
      evaluation of the initial dental state of each subject based on a stomatological examination,
      an orthopantomogram, two bitewing radiographs (right and left sides) and an evaluation of all
      potential risks of caries and fractures. For all of subjects, a dental decalcification,
      dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed
      before the start of RT treatment. Our previously developed predictive model for dental dose
      in function of the localisation of tumour and suspect lymph nodes based on the stomatological
      examination and on the pre-treatment imaging. An estimation of the intensity-modulated
      radiotherapy (IMRT) teeth dose will be made and translated into a colour based form of the
      pre-RT dental status. A contouring of the teeth will be performed and the planned dose for
      each tooth of each subject will be recorded by a dose volume histogram (DVH) curve based on
      the pre-treatment imaging. In the same way the mean dose and the V25 (the volume receiving 25
      Gy) of the homo- and the heterolateral parotid gland will be calculated. Based on our
      predictive model, every tooth which potentially will receive more than 40 Gy and for which
      long term survival is compromised will be avulsed at least 2 weeks before the start of RT.

      After RT, the subject will have clinical follow-up with dental evaluation every 6 months for
      36 months in order to identify possible dental events. At each consultation, a stomatological
      examination will be performed as well as two bitewing radiographs. An orthopantomogram will
      be done once a year. Furthermore, periapical X-rays will be performed if there is a dental
      complain or to refine a lesion visible on orthopantomogram.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Risk of dental complication
time frame: At 36 months after end of radiotherapy
description: Frequency of dental fractures according to the teeth radiotherapy delivered dose
measure: Risk of dental complication
time frame: At 36 months after end of radiotherapy
description: Frequency of dental caries according to the parotid radiotherapy delivered dose
measure: Validation of a "predictive dose model" of radiotherapy
time frame: At 36 months after end of radiotherapy
description: Predictive dose of radiotherapy according to the location of the tumour
measure: Validation of a "predictive dose model" of radiotherapy
time frame: At 36 months after end of radiotherapy
description: Predictive dose of radiotherapy according to the TNM stage
measure: Validation of a "predictive dose model" of radiotherapy
time frame: At 36 months after end of radiotherapy
description: Predictive dose of radiotherapy with the real dose of radiotherapy received
measure: Comparison of the predictive dose of radiotherapy with the dental complication probability
time frame: At 36 months after end of radiotherapy
description: Number of dental caries per patient
measure: Comparison of the predictive dose of radiotherapy with the dental complication probability
time frame: At 36 months after end of radiotherapy
description: Number of dental fractures per patient
measure: Comparison of the predictive dose of radiotherapy with the dental complication probability
time frame: At 36 months after end of radiotherapy
description: Number of dental avulsions per patient
measure: Assessment of Quality of life
time frame: At 36 months after end of radiotherapy
description: Avulsion-free
measure: Assessment of Quality of life
time frame: At 36 months after end of radiotherapy
description: Number of patients who developp an osteoradionecrosis of the jaw
measure: Assessment of Quality of life
time frame: At 36 months after end of radiotherapy
description: Outcome measure: completion of xerostomia questionnaire
measure: Assessment of Quality of life
time frame: At 36 months after end of radiotherapy
description: Outcome measure: completion of EORTC: QLQ-C30 questionnaire
measure: Assessment of Quality of life
time frame: At 36 months after end of radiotherapy
description: Outcome measure: completion of EORTC: QLQ-H&N43 questionnaire
arm group label: Single arm
arm group type: Experimental
description: The first phase of the study will consist of an evaluation of the initial dental state of each subject based on stomatological examination, orthopantomogram, bitewing radiographs, evaluation of potential risks of caries and fractures. Dental decalcification, dental care and/or avulsion if necessary, and afterwards, a dental splint will be performed before the start of RT treatment.Based on our predictive model, every tooth which potentially will receive more than 40 Gy and for which long term survival is compromised will be avulsed at least 2 weeks before the start of RT.
After RT, the subject will have clinical follow-up with dental evaluation every 6 months for 36 months in order to identify possible dental events. At each consultation, a stomatological examination will be performed as well as bitewing radiographs. Orthopantomogram will be done once a year. Periapical X-rays will be performed if there is a dental complain or to refine a lesion visible on orthopantomogram.
intervention type: Procedure
intervention name: Dental avulsion
description: Before radiotherapy, each subject undergoes a dental evaluation and if it is necessary, dental avulsions if their long-term survival is compromised (see in section 6.1.2) and if they are located in an area at risk to receive more than 40 Gy, so to develop osteoradionecrosis of the jaw. The avulsions should be performed as far as possible from the start of radiotherapy (RT) namely at least 2 weeks before irradiation to allow mucosal healing.
arm group label: Single arm
intervention type: Radiation
intervention name: Radiotherapy
description: Radiotherapy:
All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT).
arm group label: Single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck