<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/NCT03284320</url>
  </required_header>
  <id_info>
    <org_study_id>GISG-14</org_study_id>
    <nct_id>NCT03284320</nct_id>
  </id_info>
  <brief_title>Retrospective Study in Sarcoma Patients</brief_title>
  <acronym>ReTraSarc</acronym>
  <official_title>Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PharmaMar</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medicine Greifswald</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 objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin&#xD;
      in a large cohort of German patients with soft tissue and bone sarcomas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>- Progression free survival (PFS)</measure>
    <time_frame>At the time of every treatment documentation up to the end of treatment, approximately 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>- Overall survival (OS)</measure>
    <time_frame>At the time of every treatment documentation up to the end of treatment, approximately 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>CTCAE (Common Terminology Criteria for Adverse Events) 4.03</measure>
    <time_frame>At the time of every treatment documentation up to the end of treatment, approximately 2 years</time_frame>
    <description>Safety Evaluation according to toxitiy</description>
  </secondary_outcome>
  <enrollment type="Actual">514</enrollment>
  <condition>Sarcoma of Bone</condition>
  <condition>Sarcoma of Soft Tissue</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with soft tissue and bone sarcomas treated with Trabectedin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed soft tissue or bone sarcomas treated with at&#xD;
             least one cycle of Trabectedin in any line of therapy.&#xD;
&#xD;
          -  Age ≥18years at start of therapy with Trabectedin&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
          -  Patients already deceased may be included when the treating physician is able to&#xD;
             determine the presumptive consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No follow-up data available&#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>Daniel Pink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medicine Greifswald</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Reichardt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medicine Greifswald, Department of Internal Medicine C</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Pink D, Bertz-Lepel J, Busemann C, Bitz U, Reichardt P. Efficacy of trabectedin in patients with advanced or metastatic alveolar soft-part sarcoma. Onkologie. 2012;35(5):249-52. doi: 10.1159/000338342. Epub 2012 Apr 23.</citation>
    <PMID>22868503</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <keyword>Treatment outcome</keyword>
  <keyword>Adult</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_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/NCT03284320
org study id: GISG-14
nct id: NCT03284320
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin
      in a large cohort of German patients with soft tissue and bone sarcomas.
observational model: Cohort
time perspective: Retrospective
measure: - Progression free survival (PFS)
time frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
measure: - Overall survival (OS)
time frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
measure: CTCAE (Common Terminology Criteria for Adverse Events) 4.03
time frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
description: Safety Evaluation according to toxitiy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Pink, MD
role: Principal Investigator
affiliation: University Medicine Greifswald
last name: Peter Reichardt, MD
role: Principal Investigator
affiliation: Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch
facility: 
country: Germany
citation: Pink D, Bertz-Lepel J, Busemann C, Bitz U, Reichardt P. Efficacy of trabectedin in patients with advanced or metastatic alveolar soft-part sarcoma. Onkologie. 2012;35(5):249-52. doi: 10.1159/000338342. Epub 2012 Apr 23.
PMID: 22868503
responsible party type: Sponsor
mesh term: Sarcoma