EUCTR2007-001942-42-IT进行中（未招募）不适用
Pharmacokinetical-clinical study of intravescical gemcitabine in patients with marker lesion of superficial transitional cell carcinoma of the bladder - ND
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO0 个研究点开始时间: 2007年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with superficial transitional cell carcinoma of the bladder with 1 or more lesions 1 to 3 cm in size, new diagnosis or recurrent.
- •Informed consent obtained
- • 18 years old.
- •ECOG Performance Status 2.
- •Adequate marrow function: PTL 100.000/mm3, Hb 9 g/dl, neutrophil 1500/mm3;
- •Adequate renal function: serum creatinine less than 2 times the upper limit of normal;
- •Adequate hepatic function: bilirubin, AST and ALT less than 2 times the upper limit of normal.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Invasive bladder cancer
- •Urinary citology positive to high degree atipie
- •Bladder capacity less than 150 ml or urinary interval less than 2 houres.
- •Concurred malignancy or immunodepression
- •Creatininemie or hepatic function more than 2.5 times the upper limit of normal
- •Pregnancy or lactation
- •Cardiopatie NYHA Class II or more with congestive cardiac failure.
- •Uncontrollable bacterial, viral or fungine infection
- •Confusional State or time/space disorientation.
- •Every medical, psycological or social condition that could influence a suitable follow-up.
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