JPRN-UMIN000003500已完成2 期
Multicenter Phase II Study of XELOX with Bevacizumab in the Late Elderly Patients with Unresectable Advanced/Recurrent Colorectal Cancer - ASCA study
Epidemiological and Clinical Research Information Network (ECRIN)0 个研究点目标入组 35 人开始时间: 2010年4月16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
- 35
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
- 75years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Uncontrolled pleural effusion or ascites. 2)Brain metastasis. 3)Other active malignancies or a history of other malignancies within the past 5 years. 4)Clinically problematic cerebrovascular disease or arterial thromboembolism, or history of cerebrovascular disease or arterial thromboembolism within the past 1 year. 5)Surgery, biopsy specimen with section or sutures within the past 4 weeks. Fine needle aspiration biopsy within 1 week. 6)Planning of surgery during the trial. 7)Clotting drug use within the past 10 days. 8)Bleeding tendency. 9)Uncontrolled peptic ulcer. 10)Perforation of the digestive tract or history of the perforation of the digestive tract within the past 6 months. 11)Untreated traumatic bone fracture. 12)Nephropathy that requires medication or transfusion or urine protein over +2 within 2 weeks examination. 13)Uncontrolled hypertension. 14)Uncontrolled diabetes mellitus. 15)Clinically problematic cardiac disease (grade 2 or more, based on Common Toxicity Criteria for Adverse Events [CTCAE] ver.4.0 within the past 12 months). 16)History of hypersensitivity against fluorouracil or platinum agents. 17)History of the adverse events related to dihydropyrimidine dehydrogenase deficiency against fluorinated pyrimidines. 18)Uncontrolled diarrhea. 19)Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.). 20)Organ transplant that requires any immunosuppressant. 21)Uncontrolled infection. 22)History of bevacizumab use. 23)Unable to intake orally. 24)Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
研究者
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