<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/NCT01733823</url>
  </required_header>
  <id_info>
    <org_study_id>DAHANCA 28A</org_study_id>
    <nct_id>NCT01733823</nct_id>
  </id_info>
  <brief_title>DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole</brief_title>
  <official_title>Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole for Patients With Stage III-IV p16 Negative Squamous Cell Cancer (SCC) of the Larynx, Pharynx and Oral Cavity</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>
      P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of&#xD;
      head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and&#xD;
      nimorazole has been shown to improve local control. The purpose of the study i to investigate&#xD;
      the level of co-morbidity and performance status (PS) that allows the combination of all of&#xD;
      the above means of treatment intensification&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)</time_frame>
    <description>Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute toxicity</measure>
    <time_frame>2 months after end of radiotherapy</time_frame>
    <description>In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>2 months after end of radiotherapy</time_frame>
    <description>Proportion of complete and partial responders</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>HNSCC,Larynx, Pharynx and Oral Cavity</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PS 0-1 Charlson &gt;=2 Will start inclusion after Group A and B Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PS 2, Charlson: Any Will start inclusion after Group C Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole</intervention_name>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity&#xD;
&#xD;
          -  P16 negative&#xD;
&#xD;
          -  T1-4&#xD;
&#xD;
          -  N1-3&#xD;
&#xD;
          -  M0&#xD;
&#xD;
          -  Organ function and performance status allowing radical chemo-radiotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Jens Overgaard, MD, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Head and Neck Cancer Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus</name>
      <address>
        <city>Aarhus</city>
        <state>Aarhus C</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense</name>
      <address>
        <city>Odense</city>
        <state>Odense C</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg</name>
      <address>
        <city>Aalborg</city>
        <zip>9100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</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>Laryngeal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nimorazole</mesh_term>
  </intervention_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/NCT01733823
org study id: DAHANCA 28A
nct id: NCT01733823
lead sponsor: 
has dmc: No
P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of
      head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and
      nimorazole has been shown to improve local control. The purpose of the study i to investigate
      the level of co-morbidity and performance status (PS) that allows the combination of all of
      the above means of treatment intensification
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Compliance
time frame: End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)
description: Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time
measure: Acute toxicity
time frame: 2 months after end of radiotherapy
description: In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales
measure: Response rate
time frame: 2 months after end of radiotherapy
description: Proportion of complete and partial responders
arm group label: Group A
arm group type: Experimental
description: Performance scale 0-1, Charlson co-morbidity score=0 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
arm group label: Group B
arm group type: Experimental
description: PS 0-1 Charlson=1 Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
arm group label: Group C
arm group type: Experimental
description: PS 0-1 Charlson >=2 Will start inclusion after Group A and B Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
arm group label: Group D
arm group type: Experimental
description: PS 2, Charlson: Any Will start inclusion after Group C Treatment: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
intervention type: Radiation
intervention name: 76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Overgaard, MD, DMSc
role: Principal Investigator
affiliation: Danish Head and Neck Cancer Group
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Laryngeal Diseases
mesh term: Nimorazole