A Multicenter Randomized Controlled Trial of D2 Versus D2 + Lymph Node 14v Dissection in Clinical Stage T3N+, T4N+ of Gastric Cancer (14VIGTORY Trial)
试验速览
- 阶段
- 3 期
- 入组人数
- 518
- 试验地点
- 12
- 主要终点
- 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
研究概览
简要总结
The purpose of this study is to compare the survival rate according to the presence or absence of 14v lymph node dissection.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •\ * 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
排除标准
- •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
研究组 & 干预措施
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
干预措施: D2 lymphadenectomy (Procedure)
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
干预措施: D2 and #14v lymphadenectomy (Procedure)
结局指标
主要结局
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
时间窗: 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.
次要结局
未报告次要终点
研究者
Hong Man Yoon
Principal Investigator
National Cancer Center, Korea