jRCTs031180263已完成不适用
Phase 2 study of S-IROX as down staging chemotherapy for borderline resectable pancreatic cancer (BR-SIROX)
未提供0 个研究点目标入组 24 人开始时间: 2018年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- All
入选标准
- •1 Borderline resectable pancreatic cancer
- •2 Adenocarcinoma or Adenosquamuscarcinoma
- •3 Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
- •4 No treatment history of chemotherapy and chemoradiotherapy
- •5 No treatment history of chemotherapy and chemoradiotherapy for pancreatic cancer
- •6 No diarrhea
- •7 Orally ingestible
- •8 Appropriate biliary drainage in case of Obstructive jaundice
- •9 It has neither homozygote (UGT1A1 6/6,UGT1A1 28/28) nor double heterozygote (UGT1A1 6/28).
- •10 Adequate organ function
- •1 White blood cell less than 10.000/mm3
- •2 Neutrophil more than 1.500/mm3
- •3 Hemoglobin more than 9.0 g/dL
- •4 Platelet more than 10000/mm3
- •5 albumin more than 3.0g/dL
- •6 Total bilirubin less than 1.5mg/dL
- •7 AST less than 100U/L
- •8 ALT less than 100U/L
- •9 Serum creatinine less than 1.2mg/dL(Male), Serum creatinine less than 1.0mg/dL(Femal)
- •11 Written informed consent
- •12 Agree with operation
排除标准
- •1 Multiple primary cancers with disease-free period less than 5 years
- •2 Active infection
- •3 Fever more than 38
- •5 Uncontrolled mental disease
- •6 Continuous administration of immunosuppressive drugs including steroids
- •7 Interstitial pneumonia
- •8 Serious complications
- •9 Unstable angina
- •10 Continuous administration of flucytosine, phenytoin, warfarin potassium
- •11 Allergy of contrast agent
结局指标
主要结局
-
R0 Resection rate
次要结局
未报告次要终点
研究者
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