A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 1,880
- 试验地点
- 100
- 主要终点
- overall survival
研究概览
简要总结
In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).
详细描述
■ Background of Hypothesis A. JCOG (Japanese Clinical Oncology Group) 9501 Study
: Addition of aorta lymph node dissection to D2 lymph node dissection does not increase survival rate.
Wide range of operation is not always the best treatment. If invasion rate can be kept as minimal as possible while maintaining survival rate, it can lead to more secure operation while also reducing the frequency of complication after the surgery. 20 It may be advantageous for patients in terms of operation time, cost, and quality of life.
B. COACT 1001 study A previous study which compared the feasibility of lymph node dissection in open surgery and lapraroscopic surgery for advanced gastric cancer.
11p, 12a lymph node (D2) resection rate: 79.2% and 88.8% respectively in all advance gastric cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
overall survival
时间窗: 5 year
To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B \& II advanced gastric cancer
次要结局
- Long term postoperative complications(after 30 days)
- Operating time(op day)
- disease free survival(3 year)
- Overall cost for the treatment(operation day to discharge)
- Subgroup analysis of Laparoscopic surgery versus open surgery(3 year , 5 year)
- Early postoperative complications(within 30 days)
- Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)(baseline, 1 week, 1month, 6 month, 1 year, 3 year)
- Finding biomarkers predicting lymph node metastasis and recurrence(3 year)
研究者
Young-Woo Kim
Head of Gastric Cancer Branch
National Cancer Center, Korea