JPRN-UMIN000017450已完成1 期
A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma - JACCRO CC-04 (SHOGUN trial)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) A previous history of serious drug-induced hypersensitivity. 2) A history of radiotherapy of the pelvic cavity. 3) Infection accompanied by a fever of 38.0 degrees C or higher 4) Serious concurrent disease (interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver failure, etc.). 5) Remarkable electrocardiographic abnormalities or clinically problematic heart disease (heart failure, myocardial infarction, angina pectoris). 6) Sensory neuropathy. 7) Serious diarrhea (watery stool) (however, excluding diarrhea occurring as a defecatory abnormality caused by colorectal cancer). 8) Pleural effusion or ascites that may require puncture to alleviate symptoms. 9) Synchronous multiple primary cancer or metachronous multiple primary cancer with a disease-free survival of 5 years or less (However, patients with early cancer likely to be cured by local treatment will not be excluded.). 10) Women who may (want to) become pregnant, pregnant women, or breast-feeding women. 11) Men who want to have children. 12) Current treatment with flucytosine. 13) In addition, patients who are judged by the responsible study investigator or physician in charge to be inappropriate for enrollment in the study.
研究者
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