NCT00149266终止3 期
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer
详细描述
For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.
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
- •histologically proven adenocarcinoma
- •75 years old or younger
- •forced expiratory volume in one second ≥ 50 %
- •arterial oxygen pressure in room air ≥ 70 mmHg
- •clinically T2/T3/T4 with ≤3 cm esophageal invasion
- •written consent
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
- •history of left thoracotomy, or left pleural adhesion
- •past history of myocardial infarction or positive results of exercise ECG
- •liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%
结局指标
主要结局
overall survival
次要结局
- relapse-free survival
- operative morbidity and mortality
- quality of life
研究者
研究点 (2)
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