Clinical trial · Interventional
Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer
A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)
NCT03264807CI-TRIAL-00043764unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D2 and #14v lymphadenectomy | Procedure | — | UNRESOLVED |
| D2 lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- D2 lymphadenectomy
- 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
- interventionNames
- Procedure: D2 lymphadenectomy
- type
- EXPERIMENTAL
- label
- D2 and #14v lymphadenectomy
- 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
- interventionNames
- Procedure: D2 and #14v lymphadenectomy
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
\<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
References
Publications (0)
Data not yet available
No reference posted for this study.