<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/NCT03022448</url>
  </required_header>
  <id_info>
    <org_study_id>E-Trab</org_study_id>
    <nct_id>NCT03022448</nct_id>
  </id_info>
  <brief_title>Geriatric Assessmen of Elderly &quot;Unsuited&quot; Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)</brief_title>
  <acronym>E-TRAB</acronym>
  <official_title>Geriatric Assessmen of Elderly &quot;Unsuited&quot; Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GWT-TUD GmbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GWT-TUD GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the non-interventional study is to prospectively collect and analyze data on the&#xD;
      geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with&#xD;
      focus on patients who have been assessed by the treating physician as being unsuited to&#xD;
      receive standard chemotherapy with anthracyclines and / or ifosfamide.&#xD;
&#xD;
      Trabectedin will be used according to the local SmPC. Modification of the treatment schedule&#xD;
      should follow the standard medical practice at the discretion of the treating physician and&#xD;
      is not part of this Observational Plan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>12 month after LPFV</time_frame>
    <description>Overall survival for each patient will be followed until the end of the study that is defined by 12 months after inclusion of the last patient.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Advanced Soft-tissue Sarcoma</condition>
  <condition>Metastatic Soft-tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <description>Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>This is a NIS. No intervention.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly patients with advanced and/or metastatic STS (≥ 60 years including a maximum of 1/6&#xD;
        of &quot;unsuited&quot; patients younger than 60 years)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Written informed consent&#xD;
&#xD;
          -  Age of ≥ 60 years at study inclusion with a limited number of &quot;unsuited&quot; patients&#xD;
             younger than 60 years&#xD;
&#xD;
          -  Histologically proven advanced and/or metastatic STS, intermediate/high grade&#xD;
&#xD;
          -  Presence of measurable disease according to RECIST 1.1. (optional, according to local&#xD;
             clinical practice)&#xD;
&#xD;
          -  Patients indicated for 1st line treatment with trabectedin according to local SmPC&#xD;
&#xD;
          -  ECOG Performance Status 0, 1 or 2&#xD;
&#xD;
          -  bone marrow function according to local SmPC&#xD;
&#xD;
          -  hepatic function according to local SmPC&#xD;
&#xD;
          -  Ability to understand and follow study-related instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Histologically proven advanced and/or metastatic STS of the following tumor types:&#xD;
&#xD;
          -  Embryonal rhabdomyosarcoma&#xD;
&#xD;
          -  Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)&#xD;
&#xD;
          -  Osteosarcoma (excluding extraskeletal osteosarcoma)&#xD;
&#xD;
          -  Ewing tumors/primitive neuroectodermal tumor&#xD;
&#xD;
          -  Gastrointestinal stromal tumors&#xD;
&#xD;
          -  Dermatofibrosarcoma protuberans&#xD;
&#xD;
          -  Use of any investigational agent within 28 days prior to treatment start&#xD;
&#xD;
          -  Exclusion periods from other studies or simultaneous participation in other clinical&#xD;
             studies&#xD;
&#xD;
          -  Contraindications according to the local SmPC of Yondelis® (see Appendix A)&#xD;
&#xD;
          -  Subject is in custody by order of an authority or a court of law&#xD;
&#xD;
          -  Previous assignment to the E-Trab study (An individual subject may only be included&#xD;
             once in the study)&#xD;
&#xD;
          -  Criteria which in the opinion of the investigator preclude participation for&#xD;
             scientific reasons, for reasons of compliance, or for reasons of the subject's safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernd Kasper, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörthersee</name>
      <address>
        <city>Klagenfurt</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Bad Saarow</name>
      <address>
        <city>Bad Saarow</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Berlin Buch</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Spandau</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus der TU Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg Nord</name>
      <address>
        <city>Nürnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Bern</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen</name>
      <address>
        <city>Saint Gallen</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>April 1, 2022</last_update_submitted>
  <last_update_submitted_qc>April 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>soft tissue sarcomas (STS)</keyword>
  <keyword>trabectedin</keyword>
  <keyword>metastatic STS patients</keyword>
  <keyword>overall survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</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/NCT03022448
org study id: E-Trab
nct id: NCT03022448
lead sponsor: 
has dmc: No
The aim of the non-interventional study is to prospectively collect and analyze data on the
      geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with
      focus on patients who have been assessed by the treating physician as being unsuited to
      receive standard chemotherapy with anthracyclines and / or ifosfamide.

      Trabectedin will be used according to the local SmPC. Modification of the treatment schedule
      should follow the standard medical practice at the discretion of the treating physician and
      is not part of this Observational Plan.
observational model: Case-Only
time perspective: Prospective
measure: Overall survival
time frame: 12 month after LPFV
description: Overall survival for each patient will be followed until the end of the study that is defined by 12 months after inclusion of the last patient.
arm group label: Treatment Group
description: Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
intervention type: Other
intervention name: No Intervention
description: This is a NIS. No intervention.
arm group label: Treatment Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Bernd Kasper, Prof.
role: Principal Investigator
affiliation: University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Austria
country: Germany
country: Switzerland
responsible party type: Sponsor
mesh term: Sarcoma
sharing ipd: No