<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/NCT04419935</url>
  </required_header>
  <id_info>
    <org_study_id>3100</org_study_id>
    <nct_id>NCT04419935</nct_id>
  </id_info>
  <brief_title>Lymphadenectomy in NSCLC With and Without Adjuvant Therapy</brief_title>
  <official_title>Prognostic Impact of the Kind of Lymphadenectomy and Lymph Node Characteristics on Node-positive Patients Underwent Anatomical Lung Resection With or Without Adjuvant Therapy for Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Adjuvant therapy in patients affected by NSCLC is indicated in surgically treated cases of N2&#xD;
      disease, while the actual guidelines reported the possibility of a case-by-case decision in&#xD;
      case of N1 involvement.&#xD;
&#xD;
      On the other hand, the actual categorization of patients based on the hilar or mediastinal&#xD;
      involvement (N1 or N2) risks to be too ineffective and straightforward for prognosis&#xD;
      prediction and an indication of adjuvant treatments. This issue was underlined in the 8th TNM&#xD;
      proposal for the N sub-classification, with a final proposal of different subgroups based on&#xD;
      the number of involved stations. However, the IASLC committee noted that this proposal&#xD;
      presented some limits due overlapping or not statistical significance among some survival&#xD;
      curves, so the proposal was not adopted in the staging system. Moreover, the committee stated&#xD;
      that the lack of information regarding some data such as the number of the resected or the&#xD;
      metastatic nodes might affect the results and limited other proposals.&#xD;
&#xD;
      The objectives of this study are:&#xD;
&#xD;
        -  To evaluate the prognostic role of the kind of lymphadenectomy, the number of the&#xD;
           resected and/or metastatic lymph nodes in surgically treated N positive patients in&#xD;
           terms of survival.&#xD;
&#xD;
        -  To evaluate the indication and the role of adjuvant treatments in these patients.&#xD;
&#xD;
        -  To identify patients with increased risk of early recurrence or poor survival based on&#xD;
           the lymph node involvement characteristics In particular, data will be collect in a&#xD;
           prospective database including clinical and pathological data, kind of lymphadenectomy,&#xD;
           number of resected nodes, number of metastatic nodes, kind and schedule of adjuvant&#xD;
           therapy and follow-up status&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 13, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the prognostic role of the number of resected and metastatic lymph nodes in pathologically node-positive NSCLC patients underwent surgical resection</measure>
    <time_frame>5 years</time_frame>
    <description>overall survival will be used to assess the prognostic role of number of resected and metastatic nodes.</description>
  </primary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>NSCLC</condition>
  <condition>Lymph Node Metastases</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lymphadenectomy</intervention_name>
    <description>Lymphadenctomy according with ESTS guidelines</description>
    <other_name>adjuvant therapy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients affected by Non-Small Cell Lung Cancer underwent surgical treatment with&#xD;
        anatomical resection + lymphadenectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Non-Small Cell Lung Cancer Histology&#xD;
&#xD;
          -  Anatomical lung resection (segmentectomy, lobectomy or bilobectomy, pneumonectomy)&#xD;
&#xD;
          -  Pre-operative CT and PET evaluation&#xD;
&#xD;
          -  Preoperative and postoperative tumour board discussion&#xD;
&#xD;
          -  Intraoperative lymph node assessment (minimum 3 mediastinal stations harvested)&#xD;
&#xD;
          -  Lymph node metastases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AGE &lt; 18 years&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Psychiatric disease&#xD;
&#xD;
          -  Wedge resection&#xD;
&#xD;
          -  Distant metastases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Marco Chiappetta</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</investigator_affiliation>
    <investigator_full_name>Chiappetta marco</investigator_full_name>
    <investigator_title>Medical Doctor - Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Thoracic Surgery</keyword>
  <keyword>Adjuvant therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphatic Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04419935
org study id: 3100
nct id: NCT04419935
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adjuvant therapy in patients affected by NSCLC is indicated in surgically treated cases of N2
      disease, while the actual guidelines reported the possibility of a case-by-case decision in
      case of N1 involvement.

      On the other hand, the actual categorization of patients based on the hilar or mediastinal
      involvement (N1 or N2) risks to be too ineffective and straightforward for prognosis
      prediction and an indication of adjuvant treatments. This issue was underlined in the 8th TNM
      proposal for the N sub-classification, with a final proposal of different subgroups based on
      the number of involved stations. However, the IASLC committee noted that this proposal
      presented some limits due overlapping or not statistical significance among some survival
      curves, so the proposal was not adopted in the staging system. Moreover, the committee stated
      that the lack of information regarding some data such as the number of the resected or the
      metastatic nodes might affect the results and limited other proposals.

      The objectives of this study are:

        -  To evaluate the prognostic role of the kind of lymphadenectomy, the number of the
           resected and/or metastatic lymph nodes in surgically treated N positive patients in
           terms of survival.

        -  To evaluate the indication and the role of adjuvant treatments in these patients.

        -  To identify patients with increased risk of early recurrence or poor survival based on
           the lymph node involvement characteristics In particular, data will be collect in a
           prospective database including clinical and pathological data, kind of lymphadenectomy,
           number of resected nodes, number of metastatic nodes, kind and schedule of adjuvant
           therapy and follow-up status
observational model: Cohort
time perspective: Prospective
measure: To evaluate the prognostic role of the number of resected and metastatic lymph nodes in pathologically node-positive NSCLC patients underwent surgical resection
time frame: 5 years
description: overall survival will be used to assess the prognostic role of number of resected and metastatic nodes.
intervention type: Procedure
intervention name: lymphadenectomy
description: Lymphadenctomy according with ESTS guidelines
other name: adjuvant therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
investigator full name: Chiappetta marco
investigator title: Medical Doctor - Principal Investigator
mesh term: Lymphatic Metastasis
sharing ipd: Undecided