Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)
1 other identifier
interventional
518
1 country
12
Brief Summary
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 gastric-cancer
Started Aug 2015
Typical duration for phase_3 gastric-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2015
CompletedFirst Submitted
Initial submission to the registry
August 15, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMarch 3, 2020
March 1, 2020
5.4 years
August 15, 2017
March 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
Study Arms (2)
D2 lymphadenectomy
ACTIVE COMPARATORSubtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm
D2 and #14v lymphadenectomy
EXPERIMENTALSubtotal 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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:
- WBC 3000/mm3 - 12,000/mm3
- \> Serum Hemoglobin 8.0 g/dl
- \> Serum Platelet 100 000/mm3
- \< Serum AST 100 IU/l
- \<Serum ALT 100 IU/l
- \< Total Bilirubin 2.0 mg/dl
- Written signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
The Catholic University of Korea, Incheon St. Mary'S Hospital
Incheon, Bupyeong-gu, 21431, South Korea
Dongnam Inst. of Radiological & Medical Sciences
Busan, Gijang-gun, 46033, South Korea
Gyeongsang national university hospital
Gyeongsang, Gingu-si, 52727, South Korea
National Cancer Center
Gyeonggi-do, Goyang-si, 10408, South Korea
catholic university of korea,Seoul ST. Mary's Hospital.
Seocho, Seoul, 06591, South Korea
Severance Hospital
Seoul, Sincon, 03722, South Korea
Asan Medical Center
Seoul, Songpa-gu, 05505, South Korea
A JOU University medical center
Gyeonggi-do, Suwon-si, 16499, South Korea
Pusan National University Yangsan Hospital
Gyeongsang, Yangsan-si, 50612, South Korea
Gyeongsang National University Changwon hospital
Changwon, 51472, South Korea
Dankook University Hospital
Cheonan, 31116, South Korea
The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital
Incheon, 21431, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HONG MAN YOON, MD
National Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 15, 2017
First Posted
August 29, 2017
Study Start
August 6, 2015
Primary Completion
December 30, 2020
Study Completion
December 31, 2021
Last Updated
March 3, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share