<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/NCT04455984</url>
  </required_header>
  <id_info>
    <org_study_id>193132122</org_study_id>
    <nct_id>NCT04455984</nct_id>
  </id_info>
  <brief_title>Multimodality Treatment Including Curative Resection of Advanced NSCLC</brief_title>
  <official_title>Multimodality Treatment Including Curative Resection of Advanced Stage Non-small Cell Lung Cancer - an Explorative, Retrospective Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      This study retrospectively evaluates clinical parameters and outcome of patients with&#xD;
      advanced stage non-small cell lung cancer treated with neoadjuvant therapy followed by&#xD;
      curative-intent surgery at the Divison of Thoracic Surgery at the Medical University of&#xD;
      Vienna&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be undertaken as a retrospective cohort study at Devision of Thoracic&#xD;
      Surgery, Medical University of Vienna. All patients with non-small-cell lung cancer, who&#xD;
      received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention&#xD;
      at the Devision of Thoracic Surgery, Medical University, will be included. The aim of this&#xD;
      study is to evaluate peri- and postoperative clinical parameters and short- and long-term&#xD;
      outcomes in patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</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>Overall survival</measure>
    <time_frame>18 years</time_frame>
    <description>Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery&#xD;
Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery&#xD;
Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Advanced Non-small-cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Neoadjuvant chemoradiotherapy</arm_group_label>
    <description>Patients with advanced NSCLC treated with neoadjuvant platinum-based chemoradiotherapy followed by curative-intent surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neoadjuvant chemotherapy</arm_group_label>
    <description>Patients with advanced NSCLC treated with neoadjuvant platinum-based chemotherapy followed by curative-intent surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Date collection</intervention_name>
    <description>Retrospective data analysis</description>
    <arm_group_label>Neoadjuvant chemoradiotherapy</arm_group_label>
    <arm_group_label>Neoadjuvant chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with non-small-cell lung cancer, who received an induction chemo- or&#xD;
        chemoradiotherapy followed by surgery in a curative intention at the Devision of Thoracic&#xD;
        Surgery, Medical University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with advanced NSCLC and multimodality treatment including curative-intent&#xD;
             resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with early stage NSCLC&#xD;
&#xD;
          -  Patients with advanced NSCLC without multimodality treatment&#xD;
&#xD;
          -  Patients without curative resection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Katharina Sinn, MD</last_name>
    <phone>004314040056440</phone>
    <email>katharina.sinn@meduniwien.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katharina Sinn, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Katharina Sinn</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT04455984
org study id: 193132122
nct id: NCT04455984
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study retrospectively evaluates clinical parameters and outcome of patients with
      advanced stage non-small cell lung cancer treated with neoadjuvant therapy followed by
      curative-intent surgery at the Divison of Thoracic Surgery at the Medical University of
      Vienna
This study will be undertaken as a retrospective cohort study at Devision of Thoracic
      Surgery, Medical University of Vienna. All patients with non-small-cell lung cancer, who
      received an induction chemo- or chemoradiotherapy followed by surgery in a curative intention
      at the Devision of Thoracic Surgery, Medical University, will be included. The aim of this
      study is to evaluate peri- and postoperative clinical parameters and short- and long-term
      outcomes in patients.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival
time frame: 18 years
description: Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery
Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery
Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery Overall survival of stage III NSCLC in resectable patients undergoing induction treatment and curative intent surgery
arm group label: Neoadjuvant chemoradiotherapy
description: Patients with advanced NSCLC treated with neoadjuvant platinum-based chemoradiotherapy followed by curative-intent surgery
arm group label: Neoadjuvant chemotherapy
description: Patients with advanced NSCLC treated with neoadjuvant platinum-based chemotherapy followed by curative-intent surgery
intervention type: Other
intervention name: Date collection
description: Retrospective data analysis
arm group label: Neoadjuvant chemoradiotherapy
arm group label: Neoadjuvant chemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Katharina Sinn, MD
phone: 004314040056440
email: katharina.sinn@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Katharina Sinn
investigator title: MD
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No