NCT00149279已完成3 期
Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy
详细描述
Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperatively,
- •histologically proven adenocarcinoma
- •75 years old or younger
- •forced expiratory volume in one second ≥ 50 %
- •arterial oxygen pressure in room air ≥ 70 mmHg
- •creatinine clearance ≥ 50 ml/min
- •written consent. Intraoperatively
- •Macroscopic T staging is T2-subserosa, T3, or T4
- •potentially curative operation is possible
- •no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed)
- •peritoneal lavage cytology is negative for cancer cells
排除标准
- •Carcinoma in the remnant stomach
- •Borrmann type 4 (linitis plastica)
- •synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
- •past history of myocardial infarction or positive results of exercise ECG
- •liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%
结局指标
主要结局
overall survival
次要结局
- relapse-free survival
- operative morbidity and mortality
- length of postoperative hospital stay
- quality of life
研究者
研究点 (2)
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