JPRN-UMIN000025742招募中3 期
A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE) - A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE)
Japan Clinical Oncology Group (JCOG)0 个研究点目标入组 370 人开始时间: 2017年1月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 370
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
- 80years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shorter 2) Infectious disease requiring systemic treatment 3) Body temperature of 38 degrees Celsius or higher 4) Severe mental disease 5) Requiring systemic steroid medication (>= 5 mg/day of prednisolone) 6) Under treatment by flucytosine, phenytoin, or warfarin potassium 7) Uncontrolled diabetes mellitus 8) Uncontrolled hypertension 9) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months 10) Positive for HBs antigen 11) Severe interstitial pneumonia, severe lung fibrosis, or severe emphysema 12) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved
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