<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/NCT04454697</url>
  </required_header>
  <id_info>
    <org_study_id>GUARD</org_study_id>
    <nct_id>NCT04454697</nct_id>
  </id_info>
  <brief_title>Tissue Retractors for Radiation Therapy of Head and Neck Tumors</brief_title>
  <acronym>GUARD</acronym>
  <official_title>Geweberetraktoren für Die Strahlentherapie Von Kopf-Hals-Tumoren - Prospektive Randomisierte Phase-II-Studie</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Heidelberg</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>
      The rate of therapy-associated side effects during and after radiotherapy of head and neck&#xD;
      tumors is essential. The most effective approach to reducing acute toxicity is to cut out&#xD;
      healthy tissue from the radiation field. The distance between the tumor and normal tissue can&#xD;
      be individually increased using personalized, 3D printer-based tissue retractors (GWR). Even&#xD;
      the smallest geometric changes lead to a significant dose reduction in normal tissue and&#xD;
      significant advantages for the patient.&#xD;
&#xD;
      The current randomized phase II study evaluates the use of GWR with regard to acute toxicity.&#xD;
      In addition, quality of life, long-term toxicity as well as local control and overall&#xD;
      survival 12 months after radiotherapy are evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most effective approach to reducing acute toxicity after radiotherapy is to cut out&#xD;
      healthy tissue from the radiation field. GWR can increase the distance between the tumor and&#xD;
      normal tissue. Even the smallest geometric changes lead to a significant dose reduction in&#xD;
      normal tissue and significant advantages for the patient. Adequate immobilization also&#xD;
      reduces unwanted movements, especially of the tongue.&#xD;
&#xD;
      The GWR are manufactured as combinable modules according to the &quot;modular principle&quot;. This&#xD;
      improves reproducibility and flexibility and reduces development and manufacturing costs. The&#xD;
      study is being conducted as a monocentric, prospective, randomized phase II study. A total of&#xD;
      34 patients who meet the inclusion criteria are examined for acute toxicity after&#xD;
      radiotherapy of a malignant head and neck tumor. The primary goal of the study is to reduce&#xD;
      acute toxicity through individual immobilization of the jaw and tongue. Secondary study goals&#xD;
      are the evaluation of quality of life and long-term toxicity as well as local control and&#xD;
      overall survival twelve months after radiotherapy. In both groups, radiation therapy is&#xD;
      carried out in accordance with guidelines using image-guided radiotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Actual">September 8, 2022</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>
    <intervention_model_description>Interventiongroup: Personalized GWR Controlgroupt: standardized radiation protection tooth splints</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Toxcicity</measure>
    <time_frame>immediately after completin of Radiotherapy</time_frame>
    <description>Number of grade III toxcicity events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assesment of Quality of life: questionnaire</measure>
    <time_frame>up to 12 month after completion of radiotherapy</time_frame>
    <description>Changes of Parameters on the Core Quality of Life Questionnaire C30, scores 1 to 6 (best)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assesment of Quality of life: questionnaire</measure>
    <time_frame>up to 12 month after completion of radiotherapy</time_frame>
    <description>Changes of Parameters on the Core Quality of Life Questionnaire H&amp;N35, scores 1 to 6 (best)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient receive personalized 3D-printed GWR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient receive standardized radiation protection tooth splints</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tissue retractors</intervention_name>
    <description>Patients receive a tissue retractor to spare healthy tissue during the course of radiation</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of a malignant head and neck tumor&#xD;
&#xD;
          -  Clinical target volume of radiotherapy may include portions of at least one region:&#xD;
             oral cavity; Upper jaw; Lower jaw; Oropharynx; Hypopharynx; large salivary glands&#xD;
&#xD;
          -  Indication for radiotherapy alone (postoperative or definitive)&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Karnofsky performance score ≥ 60&#xD;
&#xD;
          -  Completed wound healing after tumor resection&#xD;
&#xD;
          -  The patient's consent and written consent&#xD;
&#xD;
          -  Ability of the patient to assess the nature and scope as well as possible consequences&#xD;
             of the clinical study&#xD;
&#xD;
          -  Adequate contraception in women of childbearing potential and in men&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-radiation in the head and neck area&#xD;
&#xD;
          -  Multifocal, diffuse growing tumors&#xD;
&#xD;
          -  Inadequate regression of toxicities from previous therapies&#xD;
&#xD;
          -  Jaw clamp (cutting edge distance ≤ 2 cm)&#xD;
&#xD;
          -  Simultaneous systemic tumor therapy during radiation (especially chemotherapy and&#xD;
             immunotherapy)&#xD;
&#xD;
          -  Indications that the participant is unlikely to adhere to the study protocol (e.g.&#xD;
             lack of compliance)&#xD;
&#xD;
          -  Missing written declaration of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Adeberg, PD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Heidelberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hopsital Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Juergen Debus</investigator_full_name>
    <investigator_title>Head of Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04454697
org study id: GUARD
nct id: NCT04454697
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The rate of therapy-associated side effects during and after radiotherapy of head and neck
      tumors is essential. The most effective approach to reducing acute toxicity is to cut out
      healthy tissue from the radiation field. The distance between the tumor and normal tissue can
      be individually increased using personalized, 3D printer-based tissue retractors (GWR). Even
      the smallest geometric changes lead to a significant dose reduction in normal tissue and
      significant advantages for the patient.

      The current randomized phase II study evaluates the use of GWR with regard to acute toxicity.
      In addition, quality of life, long-term toxicity as well as local control and overall
      survival 12 months after radiotherapy are evaluated.
The most effective approach to reducing acute toxicity after radiotherapy is to cut out
      healthy tissue from the radiation field. GWR can increase the distance between the tumor and
      normal tissue. Even the smallest geometric changes lead to a significant dose reduction in
      normal tissue and significant advantages for the patient. Adequate immobilization also
      reduces unwanted movements, especially of the tongue.

      The GWR are manufactured as combinable modules according to the "modular principle". This
      improves reproducibility and flexibility and reduces development and manufacturing costs. The
      study is being conducted as a monocentric, prospective, randomized phase II study. A total of
      34 patients who meet the inclusion criteria are examined for acute toxicity after
      radiotherapy of a malignant head and neck tumor. The primary goal of the study is to reduce
      acute toxicity through individual immobilization of the jaw and tongue. Secondary study goals
      are the evaluation of quality of life and long-term toxicity as well as local control and
      overall survival twelve months after radiotherapy. In both groups, radiation therapy is
      carried out in accordance with guidelines using image-guided radiotherapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Interventiongroup: Personalized GWR Controlgroupt: standardized radiation protection tooth splints
primary purpose: Treatment
masking: None (Open Label)
measure: Toxcicity
time frame: immediately after completin of Radiotherapy
description: Number of grade III toxcicity events
measure: Assesment of Quality of life: questionnaire
time frame: up to 12 month after completion of radiotherapy
description: Changes of Parameters on the Core Quality of Life Questionnaire C30, scores 1 to 6 (best)
measure: Assesment of Quality of life: questionnaire
time frame: up to 12 month after completion of radiotherapy
description: Changes of Parameters on the Core Quality of Life Questionnaire H&N35, scores 1 to 6 (best)
arm group label: Intervention
arm group type: Experimental
description: Patient receive personalized 3D-printed GWR
arm group label: Control
arm group type: Active Comparator
description: Patient receive standardized radiation protection tooth splints
intervention type: Device
intervention name: tissue retractors
description: Patients receive a tissue retractor to spare healthy tissue during the course of radiation
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Sebastian Adeberg, PD
role: Principal Investigator
affiliation: University Hospital Heidelberg
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Juergen Debus
investigator title: Head of Department
mesh term: Head and Neck Neoplasms
sharing ipd: No