EUCTR2009-012274-13-IT进行中（未招募）1 期
ONCOFID-P (Paclitaxel-hyaluronic acid) in the intravesical therapy of patients with non-muscle invasive cancer of the bladder. A phase II marker lesion study - ND
FIDIA0 个研究点目标入组 60 人开始时间: 2009年10月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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 of both sexes, aged > 18 years, women in menopause (defined as surgically sterile or one year postmenopausal); Cytological or histological diagnosis of bladder cancer; Multiple recurrent Ta G1-G2 papillary cancer; ECOG Performance Status 0 to 1 ; Adequate bone marrow function: neutrophils = o sup. 1.500 mL; platelet count = o sup. 100.000 mm3; Hb = o sup. 10 g/dL
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Hypersensitivity to Paclitaxel or one of its constituents; T1 and Muscle-invasive disease (T2-T4). Previous or concomitant cancer of the upper urinary tract, of the prosthatic urethra, carcinoma in situ (CIS); Any previous or concomitant malignancies other than superficial bladder cancer; Presence of significant urologic disease interfering with intravesical therapy; Other chemotherapy or radiotherapy within four weeks of study entry; Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry
研究者
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