<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/NCT02248038</url>
  </required_header>
  <id_info>
    <org_study_id>ChiCTR-TRC-14004767</org_study_id>
    <secondary_id>ChiCTR-TRC-14004767</secondary_id>
    <nct_id>NCT02248038</nct_id>
  </id_info>
  <brief_title>A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery</brief_title>
  <official_title>A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cai Kailin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable&#xD;
      colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was&#xD;
      not inferior to open surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS&#xD;
      of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative&#xD;
      Standard was not inferior to open surgery.&#xD;
&#xD;
      Study design：Randomized parallel control&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>Phase 3</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>5 years diseases free survival rate</measure>
    <time_frame>five years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>5 years overall survival rate</measure>
    <time_frame>five years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>open surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laparoscopic surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minimum invasive procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>open surgery</intervention_name>
    <description>Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.</description>
    <arm_group_label>open surgery</arm_group_label>
    <other_name>open</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic surgery</intervention_name>
    <description>Patients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients.</description>
    <arm_group_label>laparoscopic surgery</arm_group_label>
    <other_name>laparoscopic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. informed consent&#xD;
&#xD;
          2. single colorectal adenocarcinoma, located at any segment of the colorectum with lower&#xD;
             margin 5cm or more to the dental line&#xD;
&#xD;
          3. cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than&#xD;
             6cm&#xD;
&#xD;
          4. age less than 80 years old&#xD;
&#xD;
          5. normal blood routine test and hepatic or renal function test&#xD;
&#xD;
          6. no gastrointestinal surgery history or chemotherapy, radiation, No complete&#xD;
             obstruction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. severe comorbidity such as heart attack or stroke, malignance in 5 years&#xD;
&#xD;
          2. can not tolerate to general anesthesia, pneumoperitoneum or surgery&#xD;
&#xD;
          3. pregnant or during breast-feeding period&#xD;
&#xD;
          4. attending other clinical trial involving therapy&#xD;
&#xD;
          5. cannot or disagree to attending the clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guobin Wang, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kaixiong Tao, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kailin Cai, MD,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shi Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Union Hospital, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Cai Kailin</investigator_full_name>
    <investigator_title>Associate chief physician of gastrointestinal surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT02248038
org study id: ChiCTR-TRC-14004767
secondary id: ChiCTR-TRC-14004767
nct id: NCT02248038
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable
      colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was
      not inferior to open surgery.
Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS
      of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative
      Standard was not inferior to open surgery.

      Study design：Randomized parallel control
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 5 years diseases free survival rate
time frame: five years
measure: 5 years overall survival rate
time frame: five years
arm group label: open surgery
arm group type: Active Comparator
description: Conventional procedure
arm group label: laparoscopic surgery
arm group type: Experimental
description: Minimum invasive procedure
intervention type: Procedure
intervention name: open surgery
description: Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.
arm group label: open surgery
other name: open
intervention type: Procedure
intervention name: laparoscopic surgery
description: Patients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients.
arm group label: laparoscopic surgery
other name: laparoscopic
criteria: 
gender: All
minimum age: N/A
maximum age: 80 Years
healthy volunteers: No
last name: Guobin Wang, MD,PhD
role: Study Chair
affiliation: Wuhan Union Hospital, China
last name: Kaixiong Tao, MD,PhD
role: Study Director
affiliation: Wuhan Union Hospital, China
last name: Kailin Cai, MD,PhD
role: Study Director
affiliation: Wuhan Union Hospital, China
last name: Shi Wang, MD
role: Principal Investigator
affiliation: Wuhan Union Hospital, China
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Cai Kailin
investigator title: Associate chief physician of gastrointestinal surgery
mesh term: Colorectal Neoplasms