EUCTR2017-001189-98-DK进行中（未招募）1 期
eoadjuvant short-term Intensive Chemoresection versus Standard Adjuvant intravesical instillations in NMIBC - A study on effect and tolerability of neoadjuvant short-term intensive chemoresection and molecular markers for prediction of chemo-response - NICSA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Known history of urothelial non-invasive Ta-tumour low-grade or high-grade.
- •=18 years old
- •Mentally healthy individual
- •The ability to understand Danish orally and in writing
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Known history of invasive tumour of the bladder (T1+)
- •Known history of CIS of the bladder
- •Previous BCG-treatment within the last 24 months
- •Previous Mitomycin C-treatment (except single-shot postoperative instillation)
- •Known allergy or intolerance to Mitomycin C
- •Solid tumour with suspicions of invasion
- •Single tumour of more than 2 cm in diameter
- •Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions).
- •Small bladder volume (less than 100 ml) or incontinence
- •Acute cystitis
- •Pregnancy or breast-feeding
- •Not willing to use secure contraception with regard to men with partners and premenopausal women
研究者
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