JPRN-jRCTs051180192已完成2 期
A phase II study of systemic chemotherapy with S-1 plus oxaliplatin followed by surgery in T3/T4a and/or lymph node-positive advanced adenocarcinoma of the esophagogastric junction. (ESOX trial) - ESOX trial
Watanabe Masayuki0 个研究点目标入组 50 人开始时间: 2019年3月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Pathologically proven adenocarcinoma of the esophagus.
- •2) Siewert type I or typeII with esophageal invasion over 3 cm.
- •3) T3/T4a and/or lymph node-positive (over 1cm )
- •4) Eligible for surgery with curative intent.
- •5) no prior therapy
- •6) An age of over 20
- •7) An ECOG performance status of 0 or 1
- •8) Major organs are in normal conditions.
- •Hemoglobin => 8.0g/dL
- •neutrophil count => 1,500/mm3
- •Platelet count => 100,000/mm3
- •Serum bilirubin <= 2.0 mg/dL
- •AST, ALT <= 100 IU/L
- •Serum creatinine <= 1.3 mg/dL
- •Creatinine clearance (or estimated GFR) => 60mL/min
- •9) Written informed consent must be taken by patients
排除标准
- •1) Active synchronous or metachronous malignancy, excepting for early stage cancers
- •2) Active infectious diseases
- •3) Uncontrollable HBV infection
- •4) Pregnant or lactation women, or women with the possibility of the pregnancy.
- •5) Severe mental disorders, neurological disease
- •6) under systemic steroid therapy
- •7) under treatment of flucytosine, phenytoin or warfarin potassium
- •8) Iodoallergy
- •9) Unstable angina, or myocardial infarction within 6 months.
- •10) Patients who are judged inappropriate for the entry into this study by the investigator.
研究者
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