<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/NCT02976051</url>
  </required_header>
  <id_info>
    <org_study_id>DAHANCA 33</org_study_id>
    <nct_id>NCT02976051</nct_id>
  </id_info>
  <brief_title>DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC</brief_title>
  <official_title>DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Head and Neck Cancer Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danish Head and Neck Cancer Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET&#xD;
      scanning&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective phase II study aiming to improve the outcome in hypoxic resistent patients&#xD;
      identified by FAZA-PET.&#xD;
&#xD;
      Inclusion:&#xD;
&#xD;
      Patients must fulfill the following:&#xD;
&#xD;
      Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV,&#xD;
      Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication&#xD;
      for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Loco-regional failure</measure>
    <time_frame>Year 3</time_frame>
    <description>loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Year 3</time_frame>
    <description>Death from all causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute radiation related morbidity</measure>
    <time_frame>Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late radiation related morbidity</measure>
    <time_frame>Year 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-specific death</measure>
    <time_frame>Year 3</time_frame>
    <description>Disease-specific death is defined as death from or with the cancer in question;</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Locally Advanced Head and Neck Cancer</condition>
  <condition>Radiotherapy</condition>
  <condition>Hypoxic Radioresistance</condition>
  <arm_group>
    <arm_group_label>Treatment with HART-CN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>HART-CN</intervention_name>
    <description>HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole</description>
    <arm_group_label>Treatment with HART-CN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage III-IV larynx, pharynx, oral cavity&#xD;
&#xD;
          -  Hypoxic FAZA-PET positive&#xD;
&#xD;
          -  Indication for primary radio-chemotherapy&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HPV positive oropharynx cancer&#xD;
&#xD;
          -  Primary surgery&#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_contact>
    <last_name>Jens Overgaard, MD, DMSc</last_name>
    <phone>+45 78462629</phone>
    <email>jens@oncology.au.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mette Saksoe, MD</last_name>
    <phone>+45 78462629</phone>
    <email>mette.saksoe@oncology.au.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Experimental Clinical Oncology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000 C</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Overgaard, Prof., MD</last_name>
      <phone>+45 7846 2629</phone>
      <email>jens@oncology.au.dk</email>
    </contact>
    <contact_backup>
      <last_name>Mette Saxø, MD</last_name>
      <phone>+89492619</phone>
      <email>mette.saksoe@oncology.au.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <results_reference>
    <citation>Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.</citation>
    <PMID>23083497</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>October 18, 2020</last_update_submitted>
  <last_update_submitted_qc>October 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danish Head and Neck Cancer Group</investigator_affiliation>
    <investigator_full_name>Jens Overgaard</investigator_full_name>
    <investigator_title>Professor, MD DMSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</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/NCT02976051
org study id: DAHANCA 33
nct id: NCT02976051
lead sponsor: 
has dmc: No
Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET
      scanning
Prospective phase II study aiming to improve the outcome in hypoxic resistent patients
      identified by FAZA-PET.

      Inclusion:

      Patients must fulfill the following:

      Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV,
      Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication
      for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Loco-regional failure
time frame: Year 3
description: loco-regional failure defined as persistent or recurrent disease in tumor and/or regional lymphnode sites (within the radiotherapy treated volume). The primary endpoint did not include the effect of a successful procedure with salvage surgery (no primary neck dissection was allowed).
measure: Overall survival
time frame: Year 3
description: Death from all causes
measure: Acute radiation related morbidity
time frame: Month 3
measure: Late radiation related morbidity
time frame: Year 3
measure: Disease-specific death
time frame: Year 3
description: Disease-specific death is defined as death from or with the cancer in question;
arm group label: Treatment with HART-CN
arm group type: Experimental
description: HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cisplatin and nimorazole
intervention type: Radiation
intervention name: HART-CN
description: HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole
arm group label: Treatment with HART-CN
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Overgaard, MD, DMSc
phone: +45 78462629
email: jens@oncology.au.dk
last name: Mette Saksoe, MD
phone: +45 78462629
email: mette.saksoe@oncology.au.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
citation: Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.
PMID: 23083497
responsible party type: Principal Investigator
investigator affiliation: Danish Head and Neck Cancer Group
investigator full name: Jens Overgaard
investigator title: Professor, MD DMSc
mesh term: Hypoxia
sharing ipd: No