JPRN-UMIN000012634已完成2 期
A Randomised Phase II trial investigating the duration of adjuvant therapy(6 versus 12 months) with S-1 for patients after resection of pancreatic cancer - Postoperative Adjuvant Chemotherapy S-1 : PACS-1
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University0 个研究点目标入组 170 人开始时间: 2013年12月20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
- 170
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 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Previously treated by chemotherapy for locally advanced pancreatic cancer 2) Prior history of S-1 therapy 3) History of serious drug hypersensitivity or a history of drug allergy 4) Patients with contraindication for the medication of S-1 5) Serious complications ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, intractable diabetes, intractable hypertension) 6) Recurrent disease before enrollment 7) Moderate or ascites or pleural effusion 8) Plumonary fibrosis or interstitial pneumonia diagnosed by chest X-ray. 9) Serious diarrhea 10) Myocardial infarction within six months 11) Active infection(fever up; over 38 degree) 12) Blood transfusion within 2 weeks before enrollment 13) Severe mental disorder 14) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free survival of 5 years or less). 15) Pregnant or lactating woman and man who hope for partner's pregnancy 16) Patients who need flucytosine, phenytoin or warfarin potassium. 17) Requiring continous steroid administration 18) Not appropriate for the study at the physician's assessment
研究者
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