JPRN-UMIN000024688已完成未知
The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer - The feasibility study of TAS-118 plus Oxaliplatin or TAS-118 monotherapy as perioperative chemotherapy for locally advanced gastric cancer (APOLLO-11)
The Cancer Institute Hospital of JFCR0 个研究点目标入组 45 人开始时间: 2016年11月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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
- 20years-old 至 79years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Be sensitive seriously to ingredients of TAS-118 or Oxaliplatin (2)Be received blood transfusion, blood products and hematopoietic agents such as G-CSF within 2 weeks prior to registration (3)Be under medication with warfarin, phenytoin, flucytosine at registration (4)Have poorly controlled diarrhea (liquid stool, difficult bowel control by medical treatment, => Grade 2, defecation frequency of => 5 times/day, etc.) (5)Have peripheral sensory neuropathy or paraesthesia of => Grade 2 (6)Be with present or past history of sever pulmonary diseases (7)Be with severe (=> Grade 3, etc.) cardiac disease, or experienced cardiac infarction and/or angina within 6 months prior to registration (8)Be with diabetes mellitus poorly controlled by medical therapy or accompanying severe diabetic complications (9)Be with severe (=> Grade 3, etc.) complications (10)Be positive to HIV, or with active hepatitis (11)Be with active infections, inflammatory diseases or collagen diseases (12)Be requiring or receiving continuous systemic administration of steroids (oral or intravenous). (13)Be with active (=> Grade 3, etc.) gastrointestinal hemorrhage (14)Be with simultaneously active multiple primary cancer (simultaneous multiple cancer, and metachronous multiple primary cancers with <= 5 years disease-free period. Carcinoma in situ and lesions corresponding to intra-mucosal carcinoma judged to be cured with local therapy are not included in an active multiple cancer). (15)Females who are pregnant, nursing and possibly pregnant, or not agree to contraception during the administration period and a certain period (6 months) after the final administration of investigational product. Females of childbearing potential must have a negative pregnancy test (16)Be judged difficult to participate in the study due to mental disease or complicating psychiatric symptoms (17)Be judged not to be suitable to participate in the study by principle investigator (co-investigator)
研究者
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