JPRN-UMIN000006111招募中2 期
Phase II trial of capecitabine + bevacizumab as maintenance treatment after initial treatment with XELOX in previously untreated metastatic colorectal cancer - Phase II trial of capecitabine + bevacizumab as maintenance treatment after initial treatment with XELOX in previously untreated metastatic colorectal cancer
SGCSG: Shimane Gastroenterological Cancer Study Group0 个研究点目标入组 50 人开始时间: 2011年8月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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)History of the serious hypersensitivity for Capecitabine, Fluorouracil, Platinum or bevacizumab. History of the serious AE for Capecitabine or Fluorouracil by DPD Deficiency. (2)CNS metastases or brain cancer confirmed by imaging. (3)Cerebrovascular disease or its symptoms within 1 year. History of thromboembolism once within a year. (4)Synchronous malignant coelomic fluid that required drainage. (5)History of active double cancer within 5 years. (6)Necessity for antithrombotic drug. (7)Need tobadministrate or having anti-plateles therapy(including Methotrexate, aspirin and NSAIDS) (8)Symptom of gastrointestinal bleeding, intestinal paralysis, ileus, uncontrolled complication of peptic ulcer. (9)History of gastrointestinal perforation within 1 year. (10)Evidence of traumatic bone fracture. (11)Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry. (12)Uncontrolled hypertension or diabetes. (13)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (14)Evidence of interstitial lung disease or lung fibrosis. (15)Evidence of peripheral sensory neuropathy(>=Grade 1 according to NCI-CTCAE ver.4). (16)Uncontrolled infection. (17)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks. (18)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (19)Man who doesn't practice birth control. (20)Not appropriate for the study at the physician's assessment.
研究者
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