Back to resultsLymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D2 lymphadenectomy
D2 and #14v lymphadenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Lymph Node 14v, D2 lymphadenectomy
Eligibility Criteria
<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:
- 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
<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
Sites / Locations
- The Catholic University of Korea, Incheon St. Mary'S HospitalRecruiting
- Dongnam Inst. of Radiological & Medical SciencesRecruiting
- Gyeongsang national university hospitalRecruiting
- National Cancer CenterRecruiting
- catholic university of korea,Seoul ST. Mary's Hospital.Recruiting
- Severance HospitalRecruiting
- Asan Medical CenterRecruiting
- A JOU University medical centerRecruiting
- Pusan National University Yangsan HospitalRecruiting
- Gyeongsang National University Changwon hospitalRecruiting
- Dankook University HospitalRecruiting
- The CATHOLIC University of KOREA, INCHEON ST.MARY's hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
D2 lymphadenectomy
D2 and #14v lymphadenectomy
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03264807
First Posted
August 15, 2017
Last Updated
March 1, 2020
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03264807
Brief Title
Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 6, 2015 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Lymph Node 14v, D2 lymphadenectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
518 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D2 lymphadenectomy
Arm Type
Active Comparator
Arm 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 Title
D2 and #14v lymphadenectomy
Arm Type
Experimental
Arm 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(s)
D2 lymphadenectomy
Other Intervention Name(s)
Subtotal gastrectomy
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
D2 and #14v lymphadenectomy
Other Intervention Name(s)
Subtotal gastrectomy, D2 lymphadenectomy, #14v lymphadenectomy
Intervention 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.
Primary Outcome Measure Information:
Title
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
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.
Time Frame
the last recruited patient was followed up for 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
<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:
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
<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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HONG MAN YOON, MD
Phone
+82-31-920-1710
Email
red10000@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HONG MAN YOON, MD
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea, Incheon St. Mary'S Hospital
City
Incheon
State/Province
Bupyeong-gu
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jinjo Kim, doctor's
Email
kjj@catholic.ac.kr
Facility Name
Dongnam Inst. of Radiological & Medical Sciences
City
Busan
State/Province
Gijang-gun
ZIP/Postal Code
46033
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jaesuck Min, doctor's
Phone
+82-10-9567-9788
Email
mdoogy@hanmail.net
Facility Name
Gyeongsang national university hospital
City
Gyeongsang
State/Province
Gingu-si
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giho park, MD
Email
goodgsdr@gmail.com
First Name & Middle Initial & Last Name & Degree
youngjun Lee, MD
Facility Name
National Cancer Center
City
Gyeonggi-do
State/Province
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Man Yoon, doctor's
Phone
+82-01-6356-8426
Email
red10000@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
YOUNG WOO KIM, doctor's
First Name & Middle Initial & Last Name & Degree
Bang Wool Eom, doctor's
First Name & Middle Initial & Last Name & Degree
Keun Won Ryu, doctor's
Facility Name
catholic university of korea,Seoul ST. Mary's Hospital.
City
Seocho
State/Province
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanhong Lee, doctor's
Phone
+82-01-4326-6039
Email
painKiller9@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Hoseok Seo, MD
Facility Name
Severance Hospital
City
Seoul
State/Province
Sincon
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-Il Kim, master's
Phone
+82-10-2224-4986
Email
cairus@yuhs.ac
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Hwan Yook, doctor's
Phone
010-2258-8826
Email
jhyook@amc.seoul.kr
Facility Name
A JOU University medical center
City
Gyeonggi-do
State/Province
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hoom hur, doctor's
Phone
010-9065-5944
Email
hhcmc75@naver.com
Facility Name
Pusan National University Yangsan Hospital
City
Gyeongsang
State/Province
Yangsan-si
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sunhee Hwang, doctor's
Email
shhwang@pnuyh.co.kr
Facility Name
Gyeongsang National University Changwon hospital
City
Changwon
ZIP/Postal Code
51472
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sangho jung
Phone
010-5060-3214
Email
jshgnuh@naver.com
First Name & Middle Initial & Last Name & Degree
taehwan doctorsupreme@gmail.com
Facility Name
Dankook University Hospital
City
Cheonan
ZIP/Postal Code
31116
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Sub Ji, doctor's
Phone
010-2523-7271
Email
ysjee@dkuh.co.kr
Facility Name
The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinjo Kim
Email
kjj@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Chang hyun Kim
Email
gospel4@catholic.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
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