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

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

Detailed Description
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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.

Official Title
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A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: D2 lymphadenectomy
* Procedure: D2 and #14v lymphadenectomy


Participation Criteria
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Eligibility Criteria
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<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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D2 lymphadenectomy<br>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<br>* 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.<br>* Other names: Subtotal gastrectomy;|
| Experimental: D2 and #14v lymphadenectomy<br>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<br>* 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.<br>* Other names: #14v lymphadenectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymph Node 14v, D2 lymphadenectomy