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

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264807
• Other study ID #: NCC2015-0188
• Status: Recruiting
• Phase: Phase 3
• Start date: August 6, 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: National Cancer Center, Korea
• Contact: HONG MAN YOON, MD
• Phone: +82-31-920-1710
• Email: red10000[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 518
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

<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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Dongnam Inst. of Radiological & Medical Sciences	Busan	Gijang-gun
Korea, Republic of	Gyeongsang National University Changwon hospital	Changwon
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	A JOU University medical center	Gyeonggi-do	Suwon-si
Korea, Republic of	National Cancer Center	Gyeonggi-do	Goyang-si
Korea, Republic of	Gyeongsang national university hospital	Gyeongsang	Gingu-si
Korea, Republic of	Pusan National University Yangsan Hospital	Gyeongsang	Yangsan-si
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary'S Hospital	Incheon	Bupyeong-gu
Korea, Republic of	The CATHOLIC University of KOREA, INCHEON ST.MARY's hospital	Incheon
Korea, Republic of	catholic university of korea,Seoul ST. Mary's Hospital.	Seocho	Seoul
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Severance Hospital	Seoul	Sincon

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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