<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/NCT02966769</url>
  </required_header>
  <id_info>
    <org_study_id>GICOR -SEOR 5-16</org_study_id>
    <nct_id>NCT02966769</nct_id>
  </id_info>
  <brief_title>N2 Lung Cancer Project: Neoadjuvant Treatment Followed Surgery Versus Chemoradiation</brief_title>
  <official_title>Multicentric Retrospective Observation Study: Neoadjuvant Treatment and Surgery Versus Definitive Chemoradiation in the Non-Small Cell Lung Cancer (NSCLC) IIIA-N2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo de Investigación Clínica en Oncología Radioterapia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo de Investigación Clínica en Oncología Radioterapia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this multicenter retrospective study is to compare overall survival in&#xD;
      patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus&#xD;
      definitive chemoradiation.&#xD;
&#xD;
      Secondary objectives are to analyze disease-free survival, median survival, locoregional and&#xD;
      distant relapses as well as mortality and toxicity related to treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery&#xD;
      in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive&#xD;
      radical chemoradiation treatment.&#xD;
&#xD;
      The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the&#xD;
      difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm&#xD;
      the hypothesis generated by the INT 0139.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patterns of Relapse</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">294</enrollment>
  <condition>Non-small-Cell Lung Carcinoma</condition>
  <condition>Surgery</condition>
  <condition>Stage IIIA-N2</condition>
  <condition>Chemoradiation</condition>
  <condition>Survival</condition>
  <arm_group>
    <arm_group_label>Chemoradiation Group</arm_group_label>
    <description>Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (&gt;/= 60 Gy) plus Platinum-based Chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neoadjuvant treatment plus Surgery Group</arm_group_label>
    <description>Analyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus &gt;/= 45Gy) followed by Surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Overall survival</intervention_name>
    <description>Compare overall survival between both groups.</description>
    <arm_group_label>Chemoradiation Group</arm_group_label>
    <arm_group_label>Neoadjuvant treatment plus Surgery Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage IIIA (N2) disease&#xD;
&#xD;
          -  Potentially resectable disease&#xD;
&#xD;
          -  Stage Lung Cancer with CT scan or PET-CT.&#xD;
&#xD;
          -  N2 involvement: it is not necessary pathological proof.&#xD;
&#xD;
          -  No progression after induction treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T4 or N3 stage.&#xD;
&#xD;
          -  Bulky disease or not resectable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felipe Couñago, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grupo de Investigación Clínica en Oncología Radioterapia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sara Montemuiño, MDPhd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grupo de Investigación Clínica en Oncología Radioterapia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Quiron Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28290</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>February 15, 2018</last_update_submitted>
  <last_update_submitted_qc>February 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Grupo de Investigación Clínica en Oncología Radioterapia</investigator_affiliation>
    <investigator_full_name>Felipe Couñago</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02966769
org study id: GICOR -SEOR 5-16
nct id: NCT02966769
lead sponsor: 
has dmc: No
The objective of this multicenter retrospective study is to compare overall survival in
      patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus
      definitive chemoradiation.

      Secondary objectives are to analyze disease-free survival, median survival, locoregional and
      distant relapses as well as mortality and toxicity related to treatment.
Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery
      in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive
      radical chemoradiation treatment.

      The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the
      difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm
      the hypothesis generated by the INT 0139.
observational model: Other
time perspective: Retrospective
measure: Overall survival
time frame: 5 years
measure: Disease-free survival
time frame: 5 years
measure: Patterns of Relapse
time frame: 5 years
measure: Mortality
time frame: 5 years
arm group label: Chemoradiation Group
description: Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (>/= 60 Gy) plus Platinum-based Chemotherapy
arm group label: Neoadjuvant treatment plus Surgery Group
description: Analyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus >/= 45Gy) followed by Surgery
intervention type: Other
intervention name: Overall survival
description: Compare overall survival between both groups.
arm group label: Chemoradiation Group
arm group label: Neoadjuvant treatment plus Surgery Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Felipe Couñago, MD PhD
role: Principal Investigator
affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
last name: Sara Montemuiño, MDPhd
role: Principal Investigator
affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
investigator full name: Felipe Couñago
investigator title: Doctor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No