<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/NCT03249519</url>
  </required_header>
  <id_info>
    <org_study_id>HyZer_RCT_IBT</org_study_id>
    <nct_id>NCT03249519</nct_id>
  </id_info>
  <brief_title>Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer</brief_title>
  <official_title>Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia</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 combination of radiation therapy or chemoradiation with Interstitial brachytherapy for&#xD;
      advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and&#xD;
      chemosensitive effect of an additional hyperthermia might improve the clinical outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2099</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2094</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>Overall survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease free survival (local / distant / overall)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety by Toxicity assessment according to NCI CTCAE v4.0</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">999</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Standard Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>50.4 Gy</description>
    <arm_group_label>Standard Arm</arm_group_label>
    <other_name>Radiation therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>brachytherapy</intervention_name>
    <description>35-40 Gy</description>
    <arm_group_label>Standard Arm</arm_group_label>
    <other_name>Interstitial brachytherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>weekly 40 mg/m^2 (6cycles)</description>
    <arm_group_label>Standard Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hyperthermia</intervention_name>
    <description>10 times</description>
    <arm_group_label>Standard Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmed carcinoma of the Cervix&#xD;
&#xD;
          -  FIGO-Stage IIB-IVA; earlier stages when inoperable or according to patient's wish&#xD;
&#xD;
          -  clinical M0; except: involvement of para-aortic lymph nodes&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  ECOG ≤ 2&#xD;
&#xD;
          -  Informed consent of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm&#xD;
             disturbances requiring therapy&#xD;
&#xD;
          -  Cardiac Pacemaker&#xD;
&#xD;
          -  Myocardial infarction within the past 12 months&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Complete bundle branch block&#xD;
&#xD;
          -  New York Heart Association (NYHA) class III or IV heart disease&#xD;
&#xD;
          -  Disease that would preclude chemoradiation or deep regional hyperthermia&#xD;
&#xD;
          -  Metal implants (length &gt; 2cm or dense clusters of marker clips in the pelvis)&#xD;
&#xD;
          -  Active or therapy-resistent bladder infections&#xD;
&#xD;
          -  Pre-existing or concommitant immunodeficiency Syndrome&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients not willing to use effective contraception during and up to 6 months after&#xD;
             therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Oliver Ott, MD</last_name>
    <phone>++49 9131 85</phone>
    <phone_ext>33968</phone_ext>
    <email>st-studiensekretariat@uk-erlangen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rainer Fietkau, MD</last_name>
    <phone>++49 9131 85</phone>
    <phone_ext>33968</phone_ext>
    <email>st-studiensekretariat@uk-erlangen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen, Strahlenklinik</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oliver Ott, MD</last_name>
      <phone>++49 9131 85</phone>
      <phone_ext>33968</phone_ext>
      <email>st-studiensekretariat@uk-erlangen.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 10, 2017</last_update_submitted>
  <last_update_submitted_qc>August 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiation therapy</keyword>
  <keyword>Chemoradiation</keyword>
  <keyword>Brachytherapy</keyword>
  <keyword>Hyperthermia</keyword>
  <keyword>Cervical cancer</keyword>
  <keyword>Multimodality treatment of advanced cervical cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</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/NCT03249519
org study id: HyZer_RCT_IBT
nct id: NCT03249519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for
      advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and
      chemosensitive effect of an additional hyperthermia might improve the clinical outcome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 5 years
measure: Disease free survival (local / distant / overall)
time frame: 5 years
measure: Safety by Toxicity assessment according to NCI CTCAE v4.0
time frame: 5 years
arm group label: Standard Arm
arm group type: Experimental
description: Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times
intervention type: Radiation
intervention name: Radiation
description: 50.4 Gy
arm group label: Standard Arm
other name: Radiation therapy
intervention type: Radiation
intervention name: brachytherapy
description: 35-40 Gy
arm group label: Standard Arm
other name: Interstitial brachytherapy
intervention type: Drug
intervention name: Cisplatin
description: weekly 40 mg/m^2 (6cycles)
arm group label: Standard Arm
intervention type: Other
intervention name: Hyperthermia
description: 10 times
arm group label: Standard Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oliver Ott, MD
phone: ++49 9131 85
phone ext: 33968
email: st-studiensekretariat@uk-erlangen.de
last name: Rainer Fietkau, MD
phone: ++49 9131 85
phone ext: 33968
email: st-studiensekretariat@uk-erlangen.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Hyperthermia
mesh term: Fever
mesh term: Cisplatin