Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer

March 1, 2020 updated by: Hong Man Yoon, National Cancer Center, Korea

A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)

The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

518

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Changwon, Korea, Republic of, 51472
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
        • Contact:
          • taehwan doctorsupreme@gmail.com
      • Cheonan, Korea, Republic of, 31116
        • Recruiting
        • Dankook University Hospital
        • Contact:
      • Incheon, Korea, Republic of, 21431
    • Bupyeong-gu
      • Incheon, Bupyeong-gu, Korea, Republic of, 21431
        • Recruiting
        • The Catholic University of Korea, Incheon St. Mary's Hospital
        • Contact:
    • Gijang-gun
      • Busan, Gijang-gun, Korea, Republic of, 46033
        • Recruiting
        • Dongnam Inst. of Radiological & Medical Sciences
        • Contact:
    • Gingu-si
      • Gyeongsang, Gingu-si, Korea, Republic of, 52727
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
        • Sub-Investigator:
          • youngjun Lee, MD
    • Goyang-si
      • Gyeonggi-do, Goyang-si, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
        • Contact:
        • Sub-Investigator:
          • YOUNG WOO KIM, doctor's
        • Sub-Investigator:
          • Bang Wool Eom, doctor's
        • Sub-Investigator:
          • Keun Won Ryu, doctor's
    • Seoul
      • Seocho, Seoul, Korea, Republic of, 06591
        • Recruiting
        • catholic university of korea,Seoul ST. Mary's Hospital.
        • Contact:
        • Sub-Investigator:
          • Hoseok Seo, MD
    • Sincon
      • Seoul, Sincon, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
          • Hyung-Il Kim, master's
          • Phone Number: +82-10-2224-4986
          • Email: cairus@yuhs.ac
    • Songpa-gu
      • Seoul, Songpa-gu, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
    • Suwon-si
      • Gyeonggi-do, Suwon-si, Korea, Republic of, 16499
        • Recruiting
        • A JOU University medical center
        • Contact:
    • Yangsan-si
      • Gyeongsang, Yangsan-si, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

<Inclusion Criteria>

  • Histologically proven primary gastric adenocarcinoma
  • T3N+, T4N+ by CT scan (AJCC 7th classification)
  • Distal margin of gastric cancer Location of distal margin of gastric cancer ; antrum, or angle of the stomach
  • No evidence of other distant metastasis
  • Age ≥ 20 year old
  • Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection

  • Adequate organ functions defined as indicated below:

    1. WBC 3000/mm3 - 12,000/mm3
    2. > Serum Hemoglobin 8.0 g/dl
    3. > Serum Platelet 100 000/mm3
    4. < Serum AST 100 IU/l
    5. <Serum ALT 100 IU/l
    6. < Total Bilirubin 2.0 mg/dl
  • Written signed informed consent

<Exclusion Criteria>

  • Active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
  • Gastric remnant cancer
  • Pregnant or breast-feeding women
  • Mental disorder(diagnosed with mental disorder on medical record)
  • Systemic administration of corticosteroids(include Herbal Medication)
  • Unstable angina or myocardial infarction within 6 months of the trial
  • Unstable hypertension
  • Severe respiratory disease requiring continuous oxygen therapy
  • Indications Total gastrectomy
  • Borrmann type IV in the preoperative examination (including localized)
  • Suspected LN # 14v metastasis during surgery
  • Indications Pancreatectomy
  • Suspected a metastasis of CT scans LN # 13, LN # 14
  • Clinical stage IV group is suspected or confirmed during surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: D2 lymphadenectomy
Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm
Procedure: D2 lymphadenectomy
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.
Other Names:
  • Subtotal gastrectomy
Experimental: D2 and #14v lymphadenectomy
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
Procedure: D2 and #14v lymphadenectomy
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.
Other Names:
  • Subtotal gastrectomy
  • D2 lymphadenectomy
  • #14v lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
the last recruited patient was followed up for 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: HONG MAN YOON, MD, National Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2015

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 1, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2015-0188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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