JPRN-UMIN000007931招募中2 期
Phase2 trial of Preoperative chemotherapy with XELOX prus Bv for resectable liver metastases from colorectal cancer - Relief Trial
Sano HospitalGastrointestinal Center0 个研究点目标入组 30 人开始时间: 2012年5月11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
- 30
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.clinical or radiological evidence of CNS metastases. 2. current or previous (within the last 1 year) history of cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to Day 0 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.serious non-healing ulcer 7.evidence of bleeding diathesis or coagulopathy. 8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes 9.ongoing treatment with aspirin (> 325 mg/day) 10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 11.uncontrolled hypertension 12. serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment 13.uncontrolled pleural and/or peritoneal effusion 14.past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - In-situ carcinoma of the cervix 15.interstitial lung disease, or pulmonary fibrosis 16.uncontrolled infection 17.history of organ 18. diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 19.pregnancy (positive serum pregnancy test) and lactation 20.serious drug hypersensitivity or a history of drug allergy 21.history of adverse events related to fluorouracil 22.with liver cirrhosis and/or Viral hepatitis 23.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
研究者
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