<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/NCT03264807</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2015-0188</org_study_id>
    <nct_id>NCT03264807</nct_id>
  </id_info>
  <brief_title>Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer</brief_title>
  <official_title>A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Center, Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Center, Korea</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to compare the survival rate according to the presence or&#xD;
      absence of 14v lymph node dissection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the survival rate according to the presence or&#xD;
      absence of 14v lymph node dissection. Actually, if the 14v lymph node metastasis is suspected&#xD;
      before surgery, it is excluded from the study. In a retrospective study conducted in our&#xD;
      hospital, we compared the patients with the 14v lymphadenectomy group and those without the&#xD;
      14v lymphadenectomy group, the survival rate of the 14v lymphadenectomy group was 11% higher&#xD;
      than that of the 14v non-lymphadenectomy group.Previous studies have suggested that the&#xD;
      presence of metastatic lymph nodes in the 14v lymph node is not good and that removal of the&#xD;
      14v lymph node does not affect prognosis. However, if the lymph node is a continuous tissue&#xD;
      and the transition to the 14v lymph node is confirmed microscopically, a negative prognosis&#xD;
      may be expected because it is likely that the cancer has spread to the distal lymph node. In&#xD;
      addition, inadequate resection of the lymphatic or 14v lymph node adjacent to the 14v lymph&#xD;
      node in the absence of evidence of metastasis of the 14v lymph node under microscopic&#xD;
      examination indicates that cancer may spread even after curative surgery, To prevent cancer&#xD;
      metastasis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 6, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>Superiority verification of disease-free survival after lymphadenectomy for D2 + 14v lymph node dissection in gastric resection in patients with T3N + and T4N + stomach cancer</measure>
    <time_frame>the last recruited patient was followed up for 3 years</time_frame>
    <description>Patients were randomized to an intention-to-treat population. The primary efficacy assessment was performed at the end of the 3-year follow-up period. The free-disease survival rates of the two groups were compared by log rank test.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">518</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>D2 lymphadenectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D2 and #14v lymphadenectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and lymph node #14v lymphadnectomy could be performed in this arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>D2 lymphadenectomy</intervention_name>
    <description>Subtotal gastrectomy with D2 lymphadenectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) is conventional surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.</description>
    <arm_group_label>D2 lymphadenectomy</arm_group_label>
    <other_name>Subtotal gastrectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>D2 and #14v lymphadenectomy</intervention_name>
    <description>Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and #14v lymphadenectomy is experimental surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.</description>
    <arm_group_label>D2 and #14v lymphadenectomy</arm_group_label>
    <other_name>Subtotal gastrectomy</other_name>
    <other_name>D2 lymphadenectomy</other_name>
    <other_name>#14v lymphadenectomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        &lt;Inclusion Criteria&gt;&#xD;
&#xD;
          -  Histologically proven primary gastric adenocarcinoma&#xD;
&#xD;
          -  T3N+, T4N+ by CT scan (AJCC 7th classification)&#xD;
&#xD;
          -  Distal margin of gastric cancer Location of distal margin of gastric cancer ; antrum,&#xD;
             or angle of the stomach&#xD;
&#xD;
          -  No evidence of other distant metastasis&#xD;
&#xD;
          -  Age ≥ 20 year old&#xD;
&#xD;
          -  Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale&#xD;
&#xD;
          -  No prior treatment of chemotherapy or radiation therapy against any other&#xD;
             malignancies, and no prior treatment for gastric cancer including endoscopic mucosal&#xD;
             resection&#xD;
&#xD;
          -  Adequate organ functions defined as indicated below:&#xD;
&#xD;
               1. WBC 3000/mm3 - 12,000/mm3&#xD;
&#xD;
               2. &gt; Serum Hemoglobin 8.0 g/dl&#xD;
&#xD;
               3. &gt; Serum Platelet 100 000/mm3&#xD;
&#xD;
               4. &lt; Serum AST 100 IU/l&#xD;
&#xD;
               5. &lt;Serum ALT 100 IU/l&#xD;
&#xD;
               6. &lt; Total Bilirubin 2.0 mg/dl&#xD;
&#xD;
          -  Written signed informed consent&#xD;
&#xD;
        &lt;Exclusion Criteria&gt;&#xD;
&#xD;
          -  Active double cancer (synchronous double cancer and metachronous double cancer within&#xD;
             five disease-free years), excluding carcinoma in situ (lesions equal to&#xD;
             intraepithelial or intramucosal cancer)&#xD;
&#xD;
          -  Gastric remnant cancer&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Mental disorder(diagnosed with mental disorder on medical record)&#xD;
&#xD;
          -  Systemic administration of corticosteroids(include Herbal Medication)&#xD;
&#xD;
          -  Unstable angina or myocardial infarction within 6 months of the trial&#xD;
&#xD;
          -  Unstable hypertension&#xD;
&#xD;
          -  Severe respiratory disease requiring continuous oxygen therapy&#xD;
&#xD;
          -  Indications Total gastrectomy&#xD;
&#xD;
          -  Borrmann type IV in the preoperative examination (including localized)&#xD;
&#xD;
          -  Suspected LN # 14v metastasis during surgery&#xD;
&#xD;
          -  Indications Pancreatectomy&#xD;
&#xD;
          -  Suspected a metastasis of CT scans LN # 13, LN # 14&#xD;
&#xD;
          -  Clinical stage IV group is suspected or confirmed during surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HONG MAN YOON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>HONG MAN YOON, MD</last_name>
    <phone>+82-31-920-1710</phone>
    <email>red10000@ncc.re.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Catholic University of Korea, Incheon St. Mary'S Hospital</name>
      <address>
        <city>Incheon</city>
        <state>Bupyeong-gu</state>
        <zip>21431</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jinjo Kim, doctor's</last_name>
      <email>kjj@catholic.ac.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dongnam Inst. of Radiological &amp; Medical Sciences</name>
      <address>
        <city>Busan</city>
        <state>Gijang-gun</state>
        <zip>46033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jaesuck Min, doctor's</last_name>
      <phone>+82-10-9567-9788</phone>
      <email>mdoogy@hanmail.net</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gyeongsang national university hospital</name>
      <address>
        <city>Gyeongsang</city>
        <state>Gingu-si</state>
        <zip>52727</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giho park, MD</last_name>
      <email>goodgsdr@gmail.com</email>
    </contact>
    <investigator>
      <last_name>youngjun Lee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Gyeonggi-do</city>
        <state>Goyang-si</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Man Yoon, doctor's</last_name>
      <phone>+82-01-6356-8426</phone>
      <email>red10000@ncc.re.kr</email>
    </contact>
    <investigator>
      <last_name>YOUNG WOO KIM, doctor's</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bang Wool Eom, doctor's</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Keun Won Ryu, doctor's</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>catholic university of korea,Seoul ST. Mary's Hospital.</name>
      <address>
        <city>Seocho</city>
        <state>Seoul</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanhong Lee, doctor's</last_name>
      <phone>+82-01-4326-6039</phone>
      <email>painKiller9@catholic.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Hoseok Seo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Sincon</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyung-Il Kim, master's</last_name>
      <phone>+82-10-2224-4986</phone>
      <email>cairus@yuhs.ac</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-gu</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jung Hwan Yook, doctor's</last_name>
      <phone>010-2258-8826</phone>
      <email>jhyook@amc.seoul.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>A JOU University medical center</name>
      <address>
        <city>Gyeonggi-do</city>
        <state>Suwon-si</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>hoom hur, doctor's</last_name>
      <phone>010-9065-5944</phone>
      <email>hhcmc75@naver.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Gyeongsang</city>
        <state>Yangsan-si</state>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sunhee Hwang, doctor's</last_name>
      <email>shhwang@pnuyh.co.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gyeongsang National University Changwon hospital</name>
      <address>
        <city>Changwon</city>
        <zip>51472</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sangho jung</last_name>
      <phone>010-5060-3214</phone>
      <email>jshgnuh@naver.com</email>
    </contact>
    <contact_backup>
      <last_name>taehwan doctorsupreme@gmail.com</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Dankook University Hospital</name>
      <address>
        <city>Cheonan</city>
        <zip>31116</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ye Sub Ji, doctor's</last_name>
      <phone>010-2523-7271</phone>
      <email>ysjee@dkuh.co.kr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital</name>
      <address>
        <city>Incheon</city>
        <zip>21431</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinjo Kim</last_name>
      <email>kjj@catholic.ac.kr</email>
    </contact>
    <contact_backup>
      <last_name>Chang hyun Kim</last_name>
      <email>gospel4@catholic.ac.kr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Center, Korea</investigator_affiliation>
    <investigator_full_name>Hong Man Yoon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lymph Node 14v</keyword>
  <keyword>D2 lymphadenectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03264807
org study id: NCC2015-0188
nct id: NCT03264807
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the survival rate according to the presence or
      absence of 14v lymph node dissection.
The purpose of this study is to compare the survival rate according to the presence or
      absence of 14v lymph node dissection. Actually, if the 14v lymph node metastasis is suspected
      before surgery, it is excluded from the study. In a retrospective study conducted in our
      hospital, we compared the patients with the 14v lymphadenectomy group and those without the
      14v lymphadenectomy group, the survival rate of the 14v lymphadenectomy group was 11% higher
      than that of the 14v non-lymphadenectomy group.Previous studies have suggested that the
      presence of metastatic lymph nodes in the 14v lymph node is not good and that removal of the
      14v lymph node does not affect prognosis. However, if the lymph node is a continuous tissue
      and the transition to the 14v lymph node is confirmed microscopically, a negative prognosis
      may be expected because it is likely that the cancer has spread to the distal lymph node. In
      addition, inadequate resection of the lymphatic or 14v lymph node adjacent to the 14v lymph
      node in the absence of evidence of metastasis of the 14v lymph node under microscopic
      examination indicates that cancer may spread even after curative surgery, To prevent cancer
      metastasis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Superiority verification of disease-free survival after lymphadenectomy for D2 + 14v lymph node dissection in gastric resection in patients with T3N + and T4N + stomach cancer
time frame: the last recruited patient was followed up for 3 years
description: Patients were randomized to an intention-to-treat population. The primary efficacy assessment was performed at the end of the 3-year follow-up period. The free-disease survival rates of the two groups were compared by log rank test.
arm group label: D2 lymphadenectomy
arm group type: Active Comparator
description: Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm
arm group label: D2 and #14v lymphadenectomy
arm group type: Experimental
description: Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and lymph node #14v lymphadnectomy could be performed in this arm
intervention type: Procedure
intervention name: D2 lymphadenectomy
description: Subtotal gastrectomy with D2 lymphadenectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) is conventional surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
arm group label: D2 lymphadenectomy
other name: Subtotal gastrectomy
intervention type: Procedure
intervention name: D2 and #14v lymphadenectomy
description: Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and #14v lymphadenectomy is experimental surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
arm group label: D2 and #14v lymphadenectomy
other name: Subtotal gastrectomy
other name: D2 lymphadenectomy
other name: #14v lymphadenectomy
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: HONG MAN YOON, MD
role: Principal Investigator
affiliation: National Cancer Center
last name: HONG MAN YOON, MD
phone: +82-31-920-1710
email: red10000@ncc.re.kr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: National Cancer Center, Korea
investigator full name: Hong Man Yoon
investigator title: Principal Investigator
mesh term: Stomach Neoplasms
sharing ipd: No