Gastric CancerPhase 3NCT03264807
Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
A Phase 3 study testing D2 lymphadenectomy and D2 and #14v lymphadenectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 12 sites in South Korea.
Trial summary
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- D2 lymphadenectomy and D2 and #14v lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 6 Aug 2015to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
<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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites, 12 recruiting
- Recruiting
Dongnam Inst. of Radiological & Medical Sciences
Busan, Gijang-gun, 46033
jaesuck Min, doctor's, +82-10-9567-9788, mdoogy@hanmail.net
- Recruiting
Gyeongsang National University Changwon hospital
Changwon, 51472
sangho jung, 010-5060-3214, jshgnuh@naver.com
taehwan doctorsupreme@gmail.com
- Recruiting
Dankook University Hospital
Cheonan, 31116
Ye Sub Ji, doctor's, 010-2523-7271, ysjee@dkuh.co.kr
- Recruiting
National Cancer Center
Gyeonggi-do, Goyang-si, 10408
Hong Man Yoon, doctor's, +82-01-6356-8426, red10000@ncc.re.kr
YOUNG WOO KIM, doctor's
- Recruiting
A JOU University medical center
Gyeonggi-do, Suwon-si, 16499
hoom hur, doctor's, 010-9065-5944, hhcmc75@naver.com
- Recruiting
Gyeongsang national university hospital
Gyeongsang, Gingu-si, 52727
Giho park, MD, goodgsdr@gmail.com
youngjun Lee, MD
- Recruiting
Pusan National University Yangsan Hospital
Gyeongsang, Yangsan-si, 50612
sunhee Hwang, doctor's, shhwang@pnuyh.co.kr
- Recruiting
The Catholic University of Korea, Incheon St. Mary'S Hospital
Incheon, Bupyeong-gu, 21431
jinjo Kim, doctor's, kjj@catholic.ac.kr
- Recruiting
The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital
Incheon, 21431
Jinjo Kim, kjj@catholic.ac.kr
Chang hyun Kim, gospel4@catholic.ac.kr
- Recruiting
catholic university of korea,Seoul ST. Mary's Hospital.
Seocho, Seoul, 06591
Hanhong Lee, doctor's, +82-01-4326-6039, painKiller9@catholic.ac.kr
Hoseok Seo, MD
- Recruiting
Severance Hospital
Seoul, Sincon, 03722
Hyung-Il Kim, master's, +82-10-2224-4986, cairus@yuhs.ac
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Jung Hwan Yook, doctor's, 010-2258-8826, jhyook@amc.seoul.kr
About this study
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)
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- D2 lymphadenectomy, D2 and #14v lymphadenectomy
- Keywords
- Lymph Node 14v, D2 lymphadenectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2 lymphadenectomyProcedure or surgery
Also called Subtotal gastrectomy
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.
D2 and #14v lymphadenectomyProcedure or surgery
Also called Subtotal gastrectomy, D2 lymphadenectomy, #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.
| Study group | Role | What they receive |
|---|---|---|
| D2 lymphadenectomy | Active comparator | Subtotal gastrectomy with D2 lymphadnectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) could be performed in this arm Receives: Procedure: D2 lymphadenectomy |
| D2 and #14v lymphadenectomy | Experimental | 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 Receives: Procedure: D2 and #14v lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the last recruited patient was followed up for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start6 Aug 2015
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hong Man Yoon, National Cancer Center, Korea
- Investigators
- HONG MAN YOON, MD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264807
- Sponsor's protocol ID
- NCC2015-0188
- Status last verified
- Mar 2020
- First submitted
- 15 Aug 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03264807
- Acronym / sponsor ID
- NCC2015-0188
- Conditions
- Gastric Cancer
- Keywords
- Lymph Node 14v, D2 lymphadenectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 6 Aug 2015 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 lymphadenectomy | Active comparator | Procedure: D2 lymphadenectomySubtotal 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 | Experimental | Procedure: D2 and #14v lymphadenectomySubtotal 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D2 lymphadenectomyAlso: Subtotal gastrectomySubtotal 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. | Procedure or surgery | D2 lymphadenectomy |
| D2 and #14v lymphadenectomyAlso: Subtotal gastrectomy, D2 lymphadenectomy, #14v lymphadenectomySubtotal 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. | Procedure or surgery | D2 and #14v lymphadenectomy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HONG MAN YOON, MD principal investigator
National Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D2 lymphadenectomy and D2 and #14v lymphadenectomy in people with Gastric Cancer, run by National Cancer Center, Korea at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HONG MAN YOON, MD (+82-31-920-1710, red10000@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: the last recruited patient was followed up for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.