<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/NCT03238378</url>
  </required_header>
  <id_info>
    <org_study_id>HyBT-H&amp;N</org_study_id>
    <nct_id>NCT03238378</nct_id>
  </id_info>
  <brief_title>Salvage Brachytherapy and Hyperthermia for Recurrent H&amp;N-tumours</brief_title>
  <acronym>HyBT-H&amp;N</acronym>
  <official_title>SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD &amp; NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</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 aim of the present trial is to assess the prospective results of protocol-based&#xD;
      interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a&#xD;
      group of selected patients where salvage surgery with clear resection margins was not&#xD;
      possible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Late side effects</measure>
    <time_frame>Effects are followed up to 5 years after therapy</time_frame>
    <description>Comparison late side effects to standard therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>up to 5 years after therapy</time_frame>
    <description>Assessment of quality of life with EORTC questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of local recurrencies</measure>
    <time_frame>up to 5 years after therapy</time_frame>
    <description>Assessment of cumulative local recurrence rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 5 years after therapy</time_frame>
    <description>Rate of Overall survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Locally Recurrent Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brachytherapy d1-5(6) Hyperthermia d2 + 5</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Brachytherapy</intervention_name>
    <description>Brachytherapy d 1-5(6)</description>
    <arm_group_label>Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperthermia</intervention_name>
    <description>Hyperthermia d 2 + 5</description>
    <arm_group_label>Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed recurrent carcinoma of the head and neck region&#xD;
&#xD;
          -  Stage rcT1-3&#xD;
&#xD;
          -  Tumor anatomy and location suitable for brachytherapy techniques.&#xD;
&#xD;
          -  cN0/pN0 or rpN+ &amp; R0 with &lt;3 pos. LND &amp; without invasion of capsula.&#xD;
&#xD;
          -  M0&#xD;
&#xD;
          -  ECOG 0-2&#xD;
&#xD;
          -  Previous radiation therapy up to at least 50 Gy&#xD;
&#xD;
          -  Previous radiation therapy completed more than 6 months ago&#xD;
&#xD;
          -  Written study-specific informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cT4&#xD;
&#xD;
          -  rpN+ with &gt;2 pos. LND or invasion of capsula&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Collagen vascular disease&#xD;
&#xD;
          -  The presence of congenital diseases with increased radiation sensitivity, for example&#xD;
             Ataxia telangiectatica or similar&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vratislav Strnad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Radiation Therapy, University Hospital Erlangen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vratislav Strnad, MD</last_name>
    <phone>++49 9131 85</phone>
    <phone_ext>33968</phone_ext>
    <email>vratislav.strnad@uk-erlangen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dept. of Radiation Therapy, University Hospital Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vratislav Strnad, MD</last_name>
      <email>vratislav.strnad@uk-erlangen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Vratislav Strnad</investigator_full_name>
    <investigator_title>Head of the Interstitial Brachytherapy at the Dept. of Radiooncology</investigator_title>
  </responsible_party>
  <keyword>head and neck cancer</keyword>
  <keyword>Locally recurrent head and neck cancer</keyword>
  <keyword>Brachytherapy</keyword>
  <keyword>Hyperthermia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</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/NCT03238378
org study id: HyBT-H&N
nct id: NCT03238378
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present trial is to assess the prospective results of protocol-based
      interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a
      group of selected patients where salvage surgery with clear resection margins was not
      possible.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Late side effects
time frame: Effects are followed up to 5 years after therapy
description: Comparison late side effects to standard therapy
measure: Quality of life
time frame: up to 5 years after therapy
description: Assessment of quality of life with EORTC questionnaires
measure: Rate of local recurrencies
time frame: up to 5 years after therapy
description: Assessment of cumulative local recurrence rate
measure: Overall survival
time frame: up to 5 years after therapy
description: Rate of Overall survival
arm group label: Therapy
arm group type: Experimental
description: Brachytherapy d1-5(6) Hyperthermia d2 + 5
intervention type: Radiation
intervention name: Brachytherapy
description: Brachytherapy d 1-5(6)
arm group label: Therapy
intervention type: Other
intervention name: Hyperthermia
description: Hyperthermia d 2 + 5
arm group label: Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vratislav Strnad, MD
role: Principal Investigator
affiliation: Dept. of Radiation Therapy, University Hospital Erlangen
last name: Vratislav Strnad, MD
phone: ++49 9131 85
phone ext: 33968
email: vratislav.strnad@uk-erlangen.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg Medical School
investigator full name: Vratislav Strnad
investigator title: Head of the Interstitial Brachytherapy at the Dept. of Radiooncology
mesh term: Head and Neck Neoplasms
mesh term: Recurrence
mesh term: Hyperthermia
mesh term: Fever