xml: <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/NCT06031246</url>
    </required_header>
    <id_info>
      <org_study_id>SELLAS</org_study_id>
      <nct_id>NCT06031246</nct_id>
    </id_info>
    <brief_title>Selective Lymph Node Dissection for cT1N0M0 Invasive NSCLC With CTR&gt;0.5 Located in the Apical Segment (ECTOP-1018)</brief_title>
    <official_title>Selective Lymph Node Dissection for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR&gt;0.5 Located in the Apical Segment: a Single-arm, Multi-center, Phase III Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered&#xD;
        as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of&#xD;
        selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR&gt;0.5&#xD;
        located in the apical segment. The main questions it aims to answer are:&#xD;
  &#xD;
        The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer&#xD;
        with CTR&gt;0.5 located in the apical segment; The post-operative lymph node metastasis and&#xD;
        recurrence-free survival. Participants will receive selective lymph node dissection as the&#xD;
        surgical procedure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2026</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>5-year overall survival</measure>
      <time_frame>5 years</time_frame>
      <description>The event is defined as the death due to any causes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lymph node metastasis</measure>
      <time_frame>5 years</time_frame>
      <description>the lymph node metastasis situation of each pathological subtype</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5-year recurrence-free survival</measure>
      <time_frame>5 years</time_frame>
      <description>The event is defined as the tumor recurrence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The accuracy of frozen section</measure>
      <time_frame>5 years</time_frame>
      <description>The concordance of frozen section and final pathological diagnosis for invasiveness</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">634</enrollment>
    <condition>Lung Adenocarcinoma</condition>
    <condition>Lymph Node Metastasis</condition>
    <arm_group>
      <arm_group_label>Selective Lymph Node Dissection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR&gt;0.5 Located in the Apical Segment</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Selective Lymph Node Dissection</intervention_name>
      <description>For patients with NSCLC with CTR&gt;0.5 located in the apical segment, the inferior mediastinal lymph node was not need to dissected</description>
      <arm_group_label>Selective Lymph Node Dissection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who sign the informed consent form and are willing to complete the study&#xD;
               according to the plan;&#xD;
  &#xD;
            2. Aged from 18 to 80 years old;&#xD;
  &#xD;
            3. ECOG equals 0 or 1;&#xD;
  &#xD;
            4. Not receiving lung cancer surgery before;&#xD;
  &#xD;
            5. Resectable peripheral cT1N0M0 tumors with CTR&gt;0.5 located in the apical segment;&#xD;
  &#xD;
            6. Non-lepidic predominant invasive NSCLC dignosed by frozen section;&#xD;
  &#xD;
            7. Not receiving chemotherapy or radiotherapy before.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Not cT1N0M0;&#xD;
  &#xD;
            2. Nodules not located in the apical segment or CTR≤0.5;&#xD;
  &#xD;
            3. Pre-invasive lung adenocarcinoma, lepidic predominant adenocarcinoma, or not lung&#xD;
               adenocarcinoma diagnosed cytologically or pathologically;&#xD;
  &#xD;
            4. Receiving lung cancer surgery before;&#xD;
  &#xD;
            5. Receiving radiotherapy or chemotherapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Haiquan Chen, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chaoqiang Deng, M.D.</last_name>
      <phone>+86-13122677592</phone>
      <email>fdudengcq@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chaoqiang Deng</name>
        <address>
          <city>Shanghai</city>
          <state>Please Select</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chaoqiang Deng</last_name>
        <email>fdudengcq@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Haiquan Chen</investigator_full_name>
      <investigator_title>Director in the Department of Thoracic Surgery, FUSCC</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenocarcinoma of Lung</mesh_term>
      <mesh_term>Lymphatic Metastasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031246
  org study id: SELLAS
  nct id: NCT06031246
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered
        as ECTOP-1018. The goal of this clinical trial is to confirm the theraputic effect of
        selective lymph node dissection for cT1N0M0 invasive non-small cell lung cancer with CTR>0.5
        located in the apical segment. The main questions it aims to answer are:
  
        The 5-year overall survival of patients having cT1N0M0 invasive non-small cell lung cancer
        with CTR>0.5 located in the apical segment; The post-operative lymph node metastasis and
        recurrence-free survival. Participants will receive selective lymph node dissection as the
        surgical procedure.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 5-year overall survival
  time frame: 5 years
  description: The event is defined as the death due to any causes.
  measure: Lymph node metastasis
  time frame: 5 years
  description: the lymph node metastasis situation of each pathological subtype
  measure: 5-year recurrence-free survival
  time frame: 5 years
  description: The event is defined as the tumor recurrence.
  measure: The accuracy of frozen section
  time frame: 5 years
  description: The concordance of frozen section and final pathological diagnosis for invasiveness
  arm group label: Selective Lymph Node Dissection
  arm group type: Experimental
  description: Selective Lymph Node Dissection is performed for cT1N0M0 Invasive Non-small Cell Lung Cancer With CTR>0.5 Located in the Apical Segment
  intervention type: Procedure
  intervention name: Selective Lymph Node Dissection
  description: For patients with NSCLC with CTR>0.5 located in the apical segment, the inferior mediastinal lymph node was not need to dissected
  arm group label: Selective Lymph Node Dissection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Haiquan Chen, M.D.
  role: Principal Investigator
  affiliation: Fudan University
  last name: Chaoqiang Deng, M.D.
  phone: +86-13122677592
  email: fdudengcq@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Haiquan Chen
  investigator title: Director in the Department of Thoracic Surgery, FUSCC
  mesh term: Adenocarcinoma of Lung
  mesh term: Lymphatic Metastasis
  sharing ipd: No