JPRN-UMIN000000842已完成未知
Randomized Prospective Trial of Intravesical Bacillus Calmette-Guerin Instillation with Low Dose versus Standard Dose for Transitional Cell Carcinoma of the Urinary Bladder - Low dose BCG study
Study Group for Low-dose BCG Intravesical Instillation Therapy0 个研究点目标入组 160 人开始时间: 2007年10月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 160
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 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Active tuberculous lesion or strongly positive tuberculin reaction*. *: Strongly positive tuberculin reaction is defined as redness with a maximum diameter of >= 10 mm accompanied by induration with redness, blister, and necrosis. 2) Active double cancer (including upper urinary tract carcinoma and prostatic urethral cancer) 3) Previously received BCG intravesical instillation therapy 4) History of upper urinary tract carcinoma 5) Previously received systemic intravenous or intra-arterial infusion of an anti-cancer drug or radiation therapy for bladder cancer 6) Previously received TURBT, systemic chemotherapy or intravesical instillation therapy with an anti-cancer drug within 4 weeks prior to biopsy 7) Contracted bladder 8) Serious drug hypersensitivity 9) Previously received local radiation therapy for the bladder 10) Patients receiving pharmacotherapy, including steroids at an immunosuppressive dose 11) Serious viral or bacterial infection 12) Interstitial pneumonia or pulmonary fibrosis 13) Severe cardiac (circulatory), pulmonary, renal, hepatic, or hematopoietic impairment 14) Other serious complications 15) Pregnant or possibly pregnant women 16) Patients the investigator considers to be inappropriate for this study
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