<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/NCT03792854</url>
  </required_header>
  <id_info>
    <org_study_id>V1 10/2018</org_study_id>
    <nct_id>NCT03792854</nct_id>
  </id_info>
  <brief_title>Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)</brief_title>
  <acronym>LANACARE</acronym>
  <official_title>Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</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>
      Observational study to evaluate longitudinal quality of life according to standardized EORTC&#xD;
      questionaires as well as functional outcome, oncological outcome and toxicity in patients&#xD;
      treated with definitive chemoradiation for anal cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational study to evaluate longitudinal quality of life according to standardized EORTC&#xD;
      questionaires as well as functional outcome, oncological outcome and toxicity in patients&#xD;
      treated with definitive chemoradiation for anal cancer. Qol will be evaluated by standardized&#xD;
      EORTC questionaires QLQ C30 and QLQ CR29. Acute and late toxicity will be assessed according&#xD;
      to CTCAE 4.03. Oncological outcome will be assessed with regard to local and distant control,&#xD;
      patterns of recurrence, freedom from treatment failure and overall survival. Correlations of&#xD;
      physicians- and patients-assessed functional outcomes are planned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qol (EORTC QLQC30) absolute values and change over time</measure>
    <time_frame>day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266</time_frame>
    <description>Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qol (EORTC QLQCR29) absolute values and change over time</measure>
    <time_frame>day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266</time_frame>
    <description>Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>local control</measure>
    <time_frame>end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266</time_frame>
    <description>absence of disease progression inside the target volume of radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>distant control</measure>
    <time_frame>end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266</time_frame>
    <description>absence of disease progression outside the target volume of radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>freedom from treatment failure</measure>
    <time_frame>end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266</time_frame>
    <description>absence of disease progression inside or outside the target volume of radiation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266</time_frame>
    <description>absence of death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acute toxicity</measure>
    <time_frame>day 0, end of week 6, 12, 19</time_frame>
    <description>acute toxicity caused by chemoradiation according to CTCAE 4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>late toxicity</measure>
    <time_frame>end of week 32, 58, 84, 110, 162, 214, 266</time_frame>
    <description>late toxicity caused by chemoradiation according to CTCAE 4.03</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anal Cancer</condition>
  <condition>Quality of Life</condition>
  <condition>Chemoradiation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EORTC QLQ C30</intervention_name>
    <description>standardized questionaire</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EORTC QLQ CR29</intervention_name>
    <description>standardized questionaire</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        see eligibility criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically proven anal cancer without distant metastases&#xD;
&#xD;
          -  indication for definitive chemoradiation therapy based on multidisciplinary evaluation&#xD;
&#xD;
          -  age &gt;=18 years&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  ability to answer the standardized questionaires according to the treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  prior systemic therapy with regard to anal cancer&#xD;
&#xD;
          -  distant metastases&#xD;
&#xD;
          -  second malignancy&#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>Falk Roeder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ludwig-Maximilians Universität München</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Falk Roeder, MD</last_name>
    <phone>+49894400</phone>
    <phone_ext>73729</phone_ext>
    <email>falk.roeder@t-online.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sabine Gerum, MD</last_name>
    <phone>+49894400</phone>
    <phone_ext>73729</phone_ext>
    <email>sabine.gerum@med.uni-muenchen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Radiation Oncology, University Hospital, LMU Munich</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Falk Roeder, MD</last_name>
      <phone>+49894400</phone>
      <phone_ext>73729</phone_ext>
      <email>Falk.Roeder@med.uni-muenchen.de</email>
    </contact>
    <contact_backup>
      <last_name>Sabine Gerum, MD</last_name>
      <phone>+49894400</phone>
      <phone_ext>73729</phone_ext>
      <email>sabine.gerum@med.uni-muenchen.de</email>
    </contact_backup>
    <investigator>
      <last_name>Franziska Walter, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Hoffmann, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Falk Roeder</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>anal cancer</keyword>
  <keyword>quality of life</keyword>
  <keyword>chemoradiation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anus 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/NCT03792854
org study id: V1 10/2018
nct id: NCT03792854
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study to evaluate longitudinal quality of life according to standardized EORTC
      questionaires as well as functional outcome, oncological outcome and toxicity in patients
      treated with definitive chemoradiation for anal cancer
Observational study to evaluate longitudinal quality of life according to standardized EORTC
      questionaires as well as functional outcome, oncological outcome and toxicity in patients
      treated with definitive chemoradiation for anal cancer. Qol will be evaluated by standardized
      EORTC questionaires QLQ C30 and QLQ CR29. Acute and late toxicity will be assessed according
      to CTCAE 4.03. Oncological outcome will be assessed with regard to local and distant control,
      patterns of recurrence, freedom from treatment failure and overall survival. Correlations of
      physicians- and patients-assessed functional outcomes are planned.
observational model: Cohort
time perspective: Prospective
measure: Qol (EORTC QLQC30) absolute values and change over time
time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
description: Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time
measure: Qol (EORTC QLQCR29) absolute values and change over time
time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
description: Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time
measure: local control
time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
description: absence of disease progression inside the target volume of radiation therapy
measure: distant control
time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
description: absence of disease progression outside the target volume of radiation therapy
measure: freedom from treatment failure
time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
description: absence of disease progression inside or outside the target volume of radiation therapy
measure: overall survival
time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
description: absence of death from any cause
measure: acute toxicity
time frame: day 0, end of week 6, 12, 19
description: acute toxicity caused by chemoradiation according to CTCAE 4.03
measure: late toxicity
time frame: end of week 32, 58, 84, 110, 162, 214, 266
description: late toxicity caused by chemoradiation according to CTCAE 4.03
intervention type: Other
intervention name: EORTC QLQ C30
description: standardized questionaire
intervention type: Other
intervention name: EORTC QLQ CR29
description: standardized questionaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Falk Roeder, MD
role: Principal Investigator
affiliation: Ludwig-Maximilians Universität München
last name: Falk Roeder, MD
phone: +49894400
phone ext: 73729
email: falk.roeder@t-online.de
last name: Sabine Gerum, MD
phone: +49894400
phone ext: 73729
email: sabine.gerum@med.uni-muenchen.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Falk Roeder
investigator title: Consultant
mesh term: Anus Neoplasms
sharing ipd: No