JPRN-UMIN000009802已完成2 期
Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer. phase II multicenter trial. - Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer. phase II multicenter trial. (NOBLE Study)
The University of Tokyo, Graduate School of Medicine. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery0 个研究点目标入组 25 人开始时间: 2013年1月18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
- 25
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) Hypersensitivity or history of the severe hypersensitivity for Bevacizumab, Fluorouracil and Leucovorin. (2) Prior abdominal non-local irradiation for colorectal cancer. (3) Complication of cerebrovascular disease or its symptoms within 1 year. (4) With sever complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, hypertension, cardiac failure, renal failure, liver dysfunction, and so on). (5) With complication of history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. (6) Massive pleural or ascites that required drainage. (7) Uncontrolled Hypertension. (8) Uncontrolled peptic ulcer. (9) Uncontrolled diarrhea. (10) Uncontrolled infection. (11)Diathesis of bleeding (history of hemoptysis, including cavitation and / or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor. (12) Patient With colonic stent. (13) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low-dose of aspirin.) (14) Active multiple primary cancer. (15) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (16) With mental disorder or psychological symptoms which disturb registration to this study. (17) Not appropriate for the study at the physician's assessment.
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