<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/NCT01707888</url>
  </required_header>
  <id_info>
    <org_study_id>PEKUPH1201</org_study_id>
    <nct_id>NCT01707888</nct_id>
  </id_info>
  <brief_title>VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung Cancer</brief_title>
  <official_title>VATS Major Lung Resection for Chinese Early-stage Non-small Cell Lung cancer-a Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS&#xD;
      major lung resection have been preferred as a standard radical procedure for early stage&#xD;
      non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major&#xD;
      lung resection for lung cancer as a real-world study in china.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS&#xD;
      major lung resection have been preferred as a standard radical procedure for early stage&#xD;
      non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major&#xD;
      lung resection for lung cancer as a real-world study in china.This is a multicenter,&#xD;
      prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung&#xD;
      resection for early stage lung cancer. Patients will be followed up every 3 months for 3&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>morbidity and mortility rate</measure>
    <time_frame>3 moths</time_frame>
    <description>perioperative complications and death rates of the group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>3y</time_frame>
    <description>To evaluate Disease Free Survival (DFS) of the group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of loco-regional and systemic recurrence</measure>
    <time_frame>3y</time_frame>
    <description>To evaluate the rate of loco-regional and systemic recurrence of the group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hospital stay.</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>to evaluate the postoperative hospital stay of the group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative drainage duration</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>to evaluate the postoperative drainage duration of the group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>to evaluate the overall survival rate of the group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>converted rate</measure>
    <time_frame>3 months</time_frame>
    <description>the rate of converted thoracotomy</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>major lung resection</arm_group_label>
    <description>Patients undergo major lung resection by thoracoscopy/VATS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracoscopy/VATS</intervention_name>
    <description>Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.</description>
    <arm_group_label>major lung resection</arm_group_label>
    <other_name>Minimal invasive surgery</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        clinical early stage(I/II) lung cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Preoperative criteria:&#xD;
&#xD;
        i) non-small cell lung cancer is suspected, ii) clinical stage I/II (3) Intraoperative&#xD;
        criteria: i) Histologically confirmed NSCLC, ii) resected by VATS or converted open&#xD;
        lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling.&#xD;
&#xD;
        (4) No prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed).&#xD;
&#xD;
        (5) No prior chemotherapy or radiation therapy for any malignant diseases. (6) Expected&#xD;
        postoperative FEV1.0&gt;=800 mL and PaO2&gt;=65 torr. (7) Performance status of 0 or 1. (8)&#xD;
        Sufficient organ functions. (9) Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active bacterial or fungous infection.&#xD;
&#xD;
          2. Simultaneous or metachronous (within the past 5 years) double cancers.&#xD;
&#xD;
          3. Women during pregnancy or breast-feeding.&#xD;
&#xD;
          4. Interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema.&#xD;
&#xD;
          5. Psychosis.&#xD;
&#xD;
          6. Systemic steroids medication.&#xD;
&#xD;
          7. Uncontrollable diabetes mellitus.&#xD;
&#xD;
          8. Uncontrollable hypertension.&#xD;
&#xD;
          9. History of severe heart disease, heart failure, myocardial infarction within the past&#xD;
             6 months or attack of angina pectoris within the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Wang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fan Yang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhao Xi Sui, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Wang, MD</last_name>
    <phone>88324078</phone>
    <email>Jwangmd@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Songlei Ou</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Keneng Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Chao-Yang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hui Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Haidian Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuqing Huang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhi Gao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking university people's hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Wang, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 13, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>January 24, 2015</last_update_submitted>
  <last_update_submitted_qc>January 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Jun Wang</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Professor</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>
  <!-- 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/NCT01707888
org study id: PEKUPH1201
nct id: NCT01707888
lead sponsor: 
has dmc: No
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS
      major lung resection have been preferred as a standard radical procedure for early stage
      non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major
      lung resection for lung cancer as a real-world study in china.
Surgery may be the best treatment choice for early stage non-small cell lung cancer. And VATS
      major lung resection have been preferred as a standard radical procedure for early stage
      non-small cell lung cancer (NSCLC).This study aim to investigate the outcome of VATS major
      lung resection for lung cancer as a real-world study in china.This is a multicenter,
      prospective study, aimed To evaluate the short-term and long- term outcome of VATS major lung
      resection for early stage lung cancer. Patients will be followed up every 3 months for 3
      years.
observational model: Case-Only
time perspective: Prospective
measure: morbidity and mortility rate
time frame: 3 moths
description: perioperative complications and death rates of the group
measure: Disease-free survival
time frame: 3y
description: To evaluate Disease Free Survival (DFS) of the group.
measure: Rate of loco-regional and systemic recurrence
time frame: 3y
description: To evaluate the rate of loco-regional and systemic recurrence of the group.
measure: Pulmonary function
time frame: 6 months after surgery
description: to evaluate the pulmonary function as measured by expiratory flow rate of the group 6 months postoperatively.
measure: Postoperative hospital stay.
time frame: 3 months postoperatively
description: to evaluate the postoperative hospital stay of the group.
measure: Postoperative drainage duration
time frame: 3 months postoperatively
description: to evaluate the postoperative drainage duration of the group.
measure: overall survival
time frame: 3 months postoperatively
description: to evaluate the overall survival rate of the group.
measure: converted rate
time frame: 3 months
description: the rate of converted thoracotomy
arm group label: major lung resection
description: Patients undergo major lung resection by thoracoscopy/VATS.
intervention type: Procedure
intervention name: Thoracoscopy/VATS
description: Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.
arm group label: major lung resection
other name: Minimal invasive surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Wang, MD
role: Study Chair
affiliation: Peking University People's Hospital
last name: Fan Yang, MD
role: Study Director
affiliation: Peking University People's Hospital
last name: Zhao Xi Sui, MD
role: Study Director
affiliation: Peking University People's Hospital
last name: Jun Wang, MD
phone: 88324078
email: Jwangmd@yahoo.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Jun Wang
investigator title: Principal Investigator, Clinical Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung