CClinicalTrials.gg
Status unknownNCT03264807Updated Mar 3, 2020

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

A Phase 3 interventional study of D2 lymphadenectomy and D2 and #14v lymphadenectomy in Gastric Cancer, sponsored by National Cancer Center, Korea. Status unknown at 12 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by National Cancer Center, Korea · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
518
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gastric Cancer

Browse trials for

Keywords

  • Lymph Node 14v
  • D2 lymphadenectomy
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
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:

    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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
518 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureD2 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.

    Also known as: Subtotal gastrectomy

  • ProcedureD2 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.

    Also known as: Subtotal gastrectomy, D2 lymphadenectomy, #14v lymphadenectomy

05

What researchers measure

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.

    Time frame: the last recruited patient was followed up for 3 years

06

Study locations

12 of 12 sites recruiting
  • The Catholic University of Korea, Incheon St. Mary'S Hospital
    Incheon, Bupyeong-gu 21431, Korea, Republic of
    Recruiting
  • Dongnam Inst. of Radiological & Medical Sciences
    Busan, Gijang-gun 46033, Korea, Republic of
    Recruiting
  • Gyeongsang national university hospital
    Gyeongsang, Gingu-si 52727, Korea, Republic of
    Recruiting
  • National Cancer Center
    Gyeonggi-do, Goyang-si 10408, Korea, Republic of
    • Hong Man Yoon, doctor's · Contact · red10000@ncc.re.kr · +82-01-6356-8426
    • YOUNG WOO KIM, doctor's · Sub investigator
    • Bang Wool Eom, doctor's · Sub investigator
    • Keun Won Ryu, doctor's · Sub investigator
    Recruiting
  • catholic university of korea,Seoul ST. Mary's Hospital.
    Seocho, Seoul 06591, Korea, Republic of
    Recruiting
  • Severance Hospital
    Seoul, Sincon 03722, Korea, Republic of
    • Hyung-Il Kim, master's · Contact · cairus@yuhs.ac · +82-10-2224-4986
    Recruiting
  • Asan Medical Center
    Seoul, Songpa-gu 05505, Korea, Republic of
    Recruiting
  • A JOU University medical center
    Gyeonggi-do, Suwon-si 16499, Korea, Republic of
    Recruiting
  • Pusan National University Yangsan Hospital
    Gyeongsang, Yangsan-si 50612, Korea, Republic of
    Recruiting
  • Gyeongsang National University Changwon hospital
    Changwon, 51472, Korea, Republic of
    • sangho jung · Contact · jshgnuh@naver.com · 010-5060-3214
    • taehwan doctorsupreme@gmail.com · Contact
    Recruiting
  • Dankook University Hospital
    Cheonan, 31116, Korea, Republic of
    Recruiting
  • The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital
    Incheon, 21431, Korea, Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03264807
Lead sponsor
National Cancer Center, Korea
Responsible party
Hong Man Yoon (Principal Investigator, National Cancer Center, Korea) — Principal investigator
First posted
Aug 29, 2017
Start date
Aug 6, 2015
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Mar 3, 2020

Study contacts

HONG MAN YOON, MD
Contact
red10000@ncc.re.kr
+82-31-920-1710
HONG MAN YOON, MD
principal investigator · National Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion