<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/NCT02994264</url>
  </required_header>
  <id_info>
    <org_study_id>ICL_2015_0002</org_study_id>
    <nct_id>NCT02994264</nct_id>
  </id_info>
  <brief_title>A Study to Compare Adjuvant Concurrent Chemoradiation (CCRT) to Adjuvant Radiation Therapy (RT) in Grade 2 and 3 Extremity Soft Tissue Sarcomas</brief_title>
  <official_title>A Retrospective Cohort Study to Assess Adjuvant Concurrent Chemoradiation (CCRT) Compared to Adjuvant Radiation Therapy (RT) in the Treatment of Grade 2 and 3 Extremity Soft Tissue Sarcomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</source>
  <brief_summary>
    <textblock>
      The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent&#xD;
      chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of&#xD;
      the extremities at the investigators institution paired with patients treated by adjuvant&#xD;
      radiation therapy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Sarcoma,Soft Tissue</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>adjuvant concurrent chemoradiation</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients records would be extracted from the electronic health record system of Institut de&#xD;
        Cancérologie de Lorraine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients consecutive enrolled from 1990 to 2004 with soft tissue sarcomas located&#xD;
             either in the limbs or girdles, superficial or deep, grade 2 or 3 (FNCLCC), who were&#xD;
             first treated with radical conservative surgery and adjuvant RT atto a minimum&#xD;
             biologically equivalent dose of 45 Gy, with or without concurrent adjuvant&#xD;
             chemotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A patient record captured outside the time frame from 1990 to 2004 with trunk,&#xD;
             retro-peritoneum, and head and neck localisations, grade 1 histology and, PS≥3, were&#xD;
             excluded as well as and those plus patients who had received neoadjuvant treatment.&#xD;
             Differentiated liposarcomas, dermatofibrosarcomas protuberans, extraskeletal Ewing's&#xD;
             sarcomas, primitive neuroectodermal tumors and osteosarcomas were also excluded due to&#xD;
             specific treatment strategies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02994264
org study id: ICL_2015_0002
nct id: NCT02994264
lead sponsor: 
The aim of the study is to retrospectively evaluate the outcome of adjuvant concurrent
      chemoradiation delivered to patients with high grade non-metastatic soft tissue sarcomas of
      the extremities at the investigators institution paired with patients treated by adjuvant
      radiation therapy
observational model: Case-Only
time perspective: Retrospective
measure: overall survival
time frame: 60 months
intervention type: Radiation
intervention name: adjuvant concurrent chemoradiation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Sarcoma