<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/NCT03253536</url>
  </required_header>
  <id_info>
    <org_study_id>Livercare</org_study_id>
    <nct_id>NCT03253536</nct_id>
  </id_info>
  <brief_title>Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma</brief_title>
  <acronym>LIVERCARE</acronym>
  <official_title>Prospective Observational Trial to Evaluate Quality of Life After Stereotactic Ablative Radiation Therapy in Patients With Hepatocellular Carcinoma</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>
      Prospective single arm, single center observational study to evaluate Quality of Life (Qol)&#xD;
      after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will&#xD;
      receive work-up, treatment and follow-up exclusively as routinely done except additional&#xD;
      quality of life measurements. Qol will be measured by standardized and validated EORTC&#xD;
      questionaires at different time points during routine follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective single arm, single center observational study to evaluate Quality of Life (Qol)&#xD;
      after stereotactic body radiotherapy (SBRT) for patients with hepatocellular cancer (HCC).&#xD;
      Patients will receive work-up, treatment and follow-up exclusively as routinely done except&#xD;
      additional quality of life measurements. This will include contrast-enhanced liver MRI or CT&#xD;
      and placement of fiducials if necessary. Radiation treatment planning will be based on&#xD;
      contrast-enhanced fourdimensional computed tomography (4D-CT) with abdominal compression.&#xD;
      Target volume definition will use an internal target volume (ITV) concept. Dose prescription&#xD;
      and fractionation will be prescribed individually based on lesion size, localisation,&#xD;
      movement and liver function according to institutional standards. Qol will be measured by&#xD;
      standardized and validated EORTC questionaires (QLQ C-30 and HCC 18) at baseline, at the end&#xD;
      of SBRT, during follow up at 6 weeks, 3,6,12,24,36,48 and 60 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">July 10, 2027</completion_date>
  <primary_completion_date type="Anticipated">July 10, 2022</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>Quality of life</measure>
    <time_frame>60 months</time_frame>
    <description>Quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acute toxicity</measure>
    <time_frame>3 months</time_frame>
    <description>physician-related acute toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>late toxicity</measure>
    <time_frame>6, 12, 24, 36, 48, 60 months</time_frame>
    <description>physician-related late toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response</measure>
    <time_frame>3 months</time_frame>
    <description>response to treatment according to imaging</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>local control</measure>
    <time_frame>60 months</time_frame>
    <description>absence of regrowth inside the treated lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hepatic control</measure>
    <time_frame>60 months</time_frame>
    <description>absence of regrowth or onset of new lesions inside the liver</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>distant control</measure>
    <time_frame>60 months</time_frame>
    <description>absence of extrahepatic progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>freedom from treatment failure</measure>
    <time_frame>60 months</time_frame>
    <description>absence of disease progression other than death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>60 months</time_frame>
    <description>absence of death of any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pattern of recurrence</measure>
    <time_frame>60 months</time_frame>
    <description>pattern of recurrence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation Qol with acute toxicity</measure>
    <time_frame>3 months</time_frame>
    <description>correlation Qol with acute toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation Qol with late toxicity</measure>
    <time_frame>6, 12, 24, 36, 48, 60 months</time_frame>
    <description>correlation Qol with late toxicity</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatocellular Cancer</condition>
  <condition>Quality of Life</condition>
  <condition>Stereotactic Body Radiation Therapy</condition>
  <condition>Observational</condition>
  <arm_group>
    <arm_group_label>entire cohort</arm_group_label>
    <description>none (observational study)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational</intervention_name>
    <description>none (observational study)</description>
    <arm_group_label>entire cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients receiving routine SBRT to 1-3 intrahepatic HCC lesions&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically or radiologically proven hepatocellular carcinoma&#xD;
&#xD;
          -  1-3 lesions suitable for stereotactic radiation therapy&#xD;
&#xD;
          -  indication for SBRT according to multidisciplinary board evaluation&#xD;
&#xD;
          -  age &gt;= 18 years&#xD;
&#xD;
          -  written informed consent for study participation&#xD;
&#xD;
          -  mental and verbal ability to complete standardized questionaires according to&#xD;
             assessment by investigator (physician)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  prior HCC specific systemic therapy&#xD;
&#xD;
          -  concurrent oncological systemic treatment&#xD;
&#xD;
          -  distant metastases&#xD;
&#xD;
          -  inadequate ability tobe compliant with the protocol or to complete standardizes&#xD;
             questionaires&#xD;
&#xD;
          -  inability to receive contrast-enhanced planning CT&#xD;
&#xD;
          -  missing ability to give informed consent&#xD;
&#xD;
          -  legal custody&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Falk Roeder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Radiation Oncology, University Hospital, LMU Munich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Falk Roeder, MD</last_name>
    <phone>+49 89 4400 73729</phone>
    <email>Falk.Roeder@med.uni-muenchen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sabine Gerum, MD</last_name>
    <phone>+49 89 4400 73729</phone>
    <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>+49 89 4400 73729</phone>
      <email>Falk.Roeder@med.uni-muenchen.de</email>
    </contact>
    <contact_backup>
      <last_name>Sabine Gerum, MD</last_name>
      <phone>+49 89 4400 73729</phone>
      <email>Sabine.Gerum@med.uni-muenchen.de</email>
    </contact_backup>
    <investigator>
      <last_name>Ladan Saleh-Ebrahimi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <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>
    <investigator>
      <last_name>Alexandra Jensen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</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 Radiation Oncology</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular Cancer</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>stereotactic body radiation therapy</keyword>
  <keyword>observational</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver 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/NCT03253536
org study id: Livercare
nct id: NCT03253536
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective single arm, single center observational study to evaluate Quality of Life (Qol)
      after stereotactic body radiotherapy for patients with hepatocellular cancer. Patients will
      receive work-up, treatment and follow-up exclusively as routinely done except additional
      quality of life measurements. Qol will be measured by standardized and validated EORTC
      questionaires at different time points during routine follow-up.
Prospective single arm, single center observational study to evaluate Quality of Life (Qol)
      after stereotactic body radiotherapy (SBRT) for patients with hepatocellular cancer (HCC).
      Patients will receive work-up, treatment and follow-up exclusively as routinely done except
      additional quality of life measurements. This will include contrast-enhanced liver MRI or CT
      and placement of fiducials if necessary. Radiation treatment planning will be based on
      contrast-enhanced fourdimensional computed tomography (4D-CT) with abdominal compression.
      Target volume definition will use an internal target volume (ITV) concept. Dose prescription
      and fractionation will be prescribed individually based on lesion size, localisation,
      movement and liver function according to institutional standards. Qol will be measured by
      standardized and validated EORTC questionaires (QLQ C-30 and HCC 18) at baseline, at the end
      of SBRT, during follow up at 6 weeks, 3,6,12,24,36,48 and 60 months.
observational model: Cohort
time perspective: Prospective
measure: Quality of life
time frame: 60 months
description: Quality of life
measure: acute toxicity
time frame: 3 months
description: physician-related acute toxicity
measure: late toxicity
time frame: 6, 12, 24, 36, 48, 60 months
description: physician-related late toxicity
measure: response
time frame: 3 months
description: response to treatment according to imaging
measure: local control
time frame: 60 months
description: absence of regrowth inside the treated lesion
measure: hepatic control
time frame: 60 months
description: absence of regrowth or onset of new lesions inside the liver
measure: distant control
time frame: 60 months
description: absence of extrahepatic progression
measure: freedom from treatment failure
time frame: 60 months
description: absence of disease progression other than death
measure: overall survival
time frame: 60 months
description: absence of death of any cause
measure: pattern of recurrence
time frame: 60 months
description: pattern of recurrence
measure: correlation Qol with acute toxicity
time frame: 3 months
description: correlation Qol with acute toxicity
measure: correlation Qol with late toxicity
time frame: 6, 12, 24, 36, 48, 60 months
description: correlation Qol with late toxicity
arm group label: entire cohort
description: none (observational study)
intervention type: Other
intervention name: observational
description: none (observational study)
arm group label: entire cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Falk Roeder, MD
role: Principal Investigator
affiliation: Department of Radiation Oncology, University Hospital, LMU Munich
last name: Falk Roeder, MD
phone: +49 89 4400 73729
email: Falk.Roeder@med.uni-muenchen.de
last name: Sabine Gerum, MD
phone: +49 89 4400 73729
email: Sabine.Gerum@med.uni-muenchen.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Falk Roeder
investigator title: Consultant Radiation Oncology
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Neoplasms
sharing ipd: No