JPRN-UMIN000000951已完成2 期
Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer - KODK7 RPII
Department of Surgery, School of Medicine, Keio University0 个研究点目标入组 72 人开始时间: 2007年12月19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
- 72
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 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)with history of myocardial infarction, drug hypersensitivity within 6 months prior to the registration. 2) Prior ventral irradiation for colorectal cancer. 3)with active infection. 4)with intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, liver dysfunction, which disturb registration to this study. 5) Massive pleural or ascites that required drainage. 6)with brain metastasis. 7)with diarrhea. 8)with active double cancer. 9)patients receiving Flucytosine or Atazanabil. 10)with mental disorder which disturbs registration to this study. 11)pregnant or nursing women or women who like be pregnant. 12)men with partner willing to get pregnant. 13)patients receiving analgesic drug or steroids. 14)doctor's decision not to be registered to this study. In addition to the above-mention, patients who hope to use Bevacizumab together has to be checked about the following factors. 1)Urine dipstick for proteinuria should be <2+ 2)Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism. 3)Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks. 4) History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. 5) Long-term daily treatment with aspirin (>325 mg/day) 6) History of evidence of bleeding tendency or coagulopathy or defect of coagulation factor (INR>=1.5) or patient who taking anticoagulant agent.
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