<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/NCT03786003</url>
  </required_header>
  <id_info>
    <org_study_id>LNVT</org_study_id>
    <nct_id>NCT03786003</nct_id>
  </id_info>
  <brief_title>ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007)</brief_title>
  <official_title>Lobectomy for Clincial Stage T1N0M0 Solid NSCLC by VATS Versus Thoracotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</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>
      This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of&#xD;
      this study is to determine video-assisted thoracoscopic surgery is non-inferior to&#xD;
      thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a randomized clinical trial comparing video-assisted thoracoscopic surgery (VATS) with&#xD;
      thoracotomy for solid clinical stage T1N0M0 NSCLC. The primary objective of the study is to&#xD;
      determine that VATS is non-inferior to thoracotomy in terms of disease-free survival (DFS).&#xD;
      Secondary objectives are to compare VATS and thoracotomy for overall survival (OS),&#xD;
      perioperative complications, pain levels and quality of life.&#xD;
&#xD;
      Although there are numerous retrospective studies have indicated feasibility and&#xD;
      effectiveness of VATS, no data has been reported from those prospective and randomized&#xD;
      clinical trials with prognostic indicators as the primary objective. Whether VATS is&#xD;
      non-inferior to thoracotomy in terms of survival is still unclear. Therefore, we design this&#xD;
      trial by recruiting patients in clinical stage T1N0M0 with solid mass on computed tomography&#xD;
      (CT). To determine the clinical stage, CT scans will be performed routinely and&#xD;
      PET-CT/EBUS-TBNA/mediastinoscopy will be conducted in patients with suspected positive&#xD;
      mediastinum lymph node or distant metastases. Detailed inclusion criteria include clinical&#xD;
      stage T1N0M0 and surgical resectable, solid appearance on CT, age 18 to 75 year and signed&#xD;
      informed consent. Exclusion criteria includes not NSCLC in pathologic analysis, no lobectomy&#xD;
      or sublobar resection, history of other malignant tumors within 5 years, history of thoracic&#xD;
      surgery or unsuitable for VATS and previous radiation or chemotherapy.&#xD;
&#xD;
      In our previous data, the 3-year DFS for cT1N0M0 patients with solid mass who were subjected&#xD;
      to thoracotomy (lobectomy or sublobar resection) was 77.9%. If the 3-year DFS of VATS arm is&#xD;
      not less than 70.9%, the VATS arm will be regarded to be non-inferior to thoracotomy. A&#xD;
      sample size of at least 1086 participants is required for performance equal to 80%, α-level&#xD;
      equal to 0.025, 1:1 recruitment and considering a dropout rate of 10%. Participants will be&#xD;
      randomly assigned to either group using a random table.&#xD;
&#xD;
      Lobectomy or sublobar resection will be conducted by standard procedures at the discretion of&#xD;
      the surgeon. Each participating surgeon will be evaluated by the trial committee to ensure&#xD;
      proper surgical technique. If the VATS is diverted to thoracotomy intraoperartively, the&#xD;
      reason will be recorded, and the cause will still be analyzed in an intention-to-treat&#xD;
      analysis. Patients will be follow-up every 6 months to 3 years after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 9, 2022</start_date>
  <completion_date type="Anticipated">February 9, 2028</completion_date>
  <primary_completion_date type="Anticipated">February 9, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>3 years after the surgery</time_frame>
    <description>Disease-free survival means the period after surgery when no disease can be detected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years after the surgery</time_frame>
    <description>Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with perioperative complication</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>The perioperative complication includes wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc within a month after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain degree and quality of life</measure>
    <time_frame>1 years after the surgery</time_frame>
    <description>Numerical rating score (NRS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1086</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>VATS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Video-assisted thoracoscopic surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thoracotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VATS</intervention_name>
    <description>Standard video assisted thoracic surgery, no use of rib-spreader.</description>
    <arm_group_label>VATS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracotomy</intervention_name>
    <description>Standard thoracotomy</description>
    <arm_group_label>Thoracotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical stage T1N0M0 and surgical resectable.&#xD;
&#xD;
          -  Solid appearance on computed tomography scan.&#xD;
&#xD;
          -  Age 18 to 75 year.&#xD;
&#xD;
          -  Signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not NSCLC in pathological analysis.&#xD;
&#xD;
          -  Not lobectomy or sublobar resection.&#xD;
&#xD;
          -  History of other malignant tumors within 5 years.&#xD;
&#xD;
          -  History of thoracic surgery or unsuitable for VATS.&#xD;
&#xD;
          -  Previous radiation or chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shanghai Cancer Center Chen, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Haoxuan Wu, M.D.</last_name>
    <phone>86-13901770461</phone>
    <email>haoxuanwu@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haiquan Chen, Ph.D</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haoxuan Wu, Doctor</last_name>
      <phone>(86)13901770461</phone>
      <email>haoxuanwu@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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</investigator_title>
  </responsible_party>
  <keyword>Video-Assisted Thoracic Surgery</keyword>
  <keyword>Thoracotomy</keyword>
  <keyword>Early-stage NSCLC</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Every 3 months after the study begin.</ipd_time_frame>
  </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/NCT03786003
org study id: LNVT
nct id: NCT03786003
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of
      this study is to determine video-assisted thoracoscopic surgery is non-inferior to
      thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC.
It is a randomized clinical trial comparing video-assisted thoracoscopic surgery (VATS) with
      thoracotomy for solid clinical stage T1N0M0 NSCLC. The primary objective of the study is to
      determine that VATS is non-inferior to thoracotomy in terms of disease-free survival (DFS).
      Secondary objectives are to compare VATS and thoracotomy for overall survival (OS),
      perioperative complications, pain levels and quality of life.

      Although there are numerous retrospective studies have indicated feasibility and
      effectiveness of VATS, no data has been reported from those prospective and randomized
      clinical trials with prognostic indicators as the primary objective. Whether VATS is
      non-inferior to thoracotomy in terms of survival is still unclear. Therefore, we design this
      trial by recruiting patients in clinical stage T1N0M0 with solid mass on computed tomography
      (CT). To determine the clinical stage, CT scans will be performed routinely and
      PET-CT/EBUS-TBNA/mediastinoscopy will be conducted in patients with suspected positive
      mediastinum lymph node or distant metastases. Detailed inclusion criteria include clinical
      stage T1N0M0 and surgical resectable, solid appearance on CT, age 18 to 75 year and signed
      informed consent. Exclusion criteria includes not NSCLC in pathologic analysis, no lobectomy
      or sublobar resection, history of other malignant tumors within 5 years, history of thoracic
      surgery or unsuitable for VATS and previous radiation or chemotherapy.

      In our previous data, the 3-year DFS for cT1N0M0 patients with solid mass who were subjected
      to thoracotomy (lobectomy or sublobar resection) was 77.9%. If the 3-year DFS of VATS arm is
      not less than 70.9%, the VATS arm will be regarded to be non-inferior to thoracotomy. A
      sample size of at least 1086 participants is required for performance equal to 80%, α-level
      equal to 0.025, 1:1 recruitment and considering a dropout rate of 10%. Participants will be
      randomly assigned to either group using a random table.

      Lobectomy or sublobar resection will be conducted by standard procedures at the discretion of
      the surgeon. Each participating surgeon will be evaluated by the trial committee to ensure
      proper surgical technique. If the VATS is diverted to thoracotomy intraoperartively, the
      reason will be recorded, and the cause will still be analyzed in an intention-to-treat
      analysis. Patients will be follow-up every 6 months to 3 years after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival
time frame: 3 years after the surgery
description: Disease-free survival means the period after surgery when no disease can be detected.
measure: Overall survival
time frame: 3 years after the surgery
description: Overall survival means the period after surgery when a patient doesn't die directly from lung cancer or an unrelated cause.
measure: Rate of patients with perioperative complication
time frame: 1 month after surgery
description: The perioperative complication includes wound infection, hemorrhage, infection, pleural effusion, pneumothorax, cardiovascular problem and etc within a month after surgery.
measure: Pain degree and quality of life
time frame: 1 years after the surgery
description: Numerical rating score (NRS)
arm group label: VATS
arm group type: Experimental
description: Video-assisted thoracoscopic surgery
arm group label: Thoracotomy
arm group type: Active Comparator
description: Open surgery
intervention type: Procedure
intervention name: VATS
description: Standard video assisted thoracic surgery, no use of rib-spreader.
arm group label: VATS
intervention type: Procedure
intervention name: Thoracotomy
description: Standard thoracotomy
arm group label: Thoracotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shanghai Cancer Center Chen, Ph.D
role: Principal Investigator
affiliation: Shanghai Cancer Center
last name: Haoxuan Wu, M.D.
phone: 86-13901770461
email: haoxuanwu@hotmail.com
last name: Haiquan Chen, Ph.D
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Haiquan Chen
investigator title: Director
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Yes
ipd description: Study Protocol, Inform Consent Form, Clinical Study Report would be shared every 3 months after the study begin.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Every 3 months after the study begin.