Randomized Controlled Trial to Evaluate Mesenteric Vein (14V) Lymphadenectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node dissection in 3-year survival rates of advanced gastric cancers.
详细描述
Radical surgery is still the only possible way to cure gastric cancer. In Japan, South Korea and other countries, due to the popularity of screening and Improved surgical procedures, there has been great improvement in overall survival. Standard D2 Gastrectomy has been the standard operation for advanced gastric cancer. However, there is no unanimous consensus whether Standard D2 Gastrectomy plus 14v lymph node dissection is needed.Till now, it is difficult to stage the 14V lymph node as regional lymph nodes metastasis or distant metastasis. And it is urgent to explore the necessity of 14v lymph node dissection in advanced gastric cancer.So a prospective randomized controlled study will to carry out to evaluate the effects of D2 radical gastrectomy plus 14v lymph node dissection compared with D2 radical gastrectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Curative D2 or D2+ operation had been performed;
- •Physical condition and organ function allows to tolerable abdominal surgery;
- •Willing and able to comply with the program during the study period;
- •Aged 18 to 70 years, preoperative gastric cancer patients with pathologically confirmed;
- •With more than a 6-month life expectancy;
- •No other serious concomitant diseases;
- •No adjuvant chemotherapy before recurrence;
- •Karnofsky performance status scale ≥ 60;
- •All patients accept 6 cycles XELOX chemotherapy regimen
排除标准
- •Pregnancy or breast feeding;
- •Women of childbearing age do not take contraceptive measures;
- •Organ transplantation patients need immunosuppressive therapy;
- •Five years after the trial begin,other malignant tumor occur;
- •While using other experimental drug or other clinical trials are being;
- •Can not take oral medications;
- •Mentally disordered;
- •Severe recurrent infections were not controlled or with other serious concomitant diseases;
结局指标
主要结局
overall survival
时间窗: 3 years
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.
次要结局
- disease free survival(3 years)