JPRN-jRCTs031180025已完成2 期
Clinical research of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology - PR-PHOENIX trial
Ishigami Hironori0 个研究点目标入组 121 人开始时间: 2018年10月12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
- 121
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 < 84age old（—）
- 性别
- All
入选标准
- •1) Pathologically proven primary gastric adenocarcinoma
- •2) Peritoneal metastasis or positive peritoneal cytology
- •3) Adequate function of important organs (within 14 days before registration)
- •NEU >=1,000/mm3
- •Hemoglobin >=8.0g/dL
- •Platelet >=75,000/mm3
- •AST <=150U/L, ALT <=150U/L
- •T-Bilirubin <=3.0mg/dL
- •Creatinine clearance >=30mL/min
- •4) Eastern Cooperative Oncology Group performance status 0-3
- •5) Age >=20, <85
- •6) Written informed consent
排除标准
- •1) Distant metastasis other than peritoneal, ovarian and abdominal lymph node metastasis
- •2) Contraindication to S-1 or paclitaxel
- •3) Apparent infection or inflammation
- •4) Severe heart disease
- •5) Severe complication
- •6) Gastrointestinal tract bleeding requiring blood transfusion
- •7) Pregnancy, breast feeding or intention to become pregnant
- •8) Judged inappropriate for this trial for other reasons
研究者
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