2024-516320-33-00招募中3 期
Intravesical instillation therapy with bacillus Calmette-Guérin (BCG) and sequential BCG and electromotive mitomycin-C (EMDA-MMC) in patients with high-risk non-muscle-invasive bladder carcinoma (FINNBLADDER 10)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence: defined as occurrence of histologically confirmed urothelial cancer recurrence of any stage or grade. Time for recurrence will be calculated from randomization date to date of biopsy/TUR-BT confirming recurrence.
研究概览
简要总结
The objective of the study is to evaluate the efficacy of intravesical BCG monotherapy and sequential BCG/EMDA-MMC in the treatment of patients with high-risk BC.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
- •Written informed consent is required from every eligible patient
- •Second resection performed in case of T1 tumour
- •Adequate physical and mental condition to participate in the study (as judged by treating physician
排除标准
- •Ta low grade tumour(s)
- •Age < 18 years
- •Pregnancy or lactating patient
- •Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
- •Cardiac pacemaker
- •Expected survival time less than one year
- •Expected poor compliance
- •Muscle invasive (pT≥2) tumors
- •Urothelial cancer involving the prostatic urethra or upper urinary tract
- •Non‐urothelial bladder cancer
- •Prior BCG failure (If patient has previously been successfully treated with BCG, and duration from the last instillation is >12 months, participation may be considered, if bladder preserving is chosen)
- •Prior or concurrent immunotherapy
- •Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)
- •Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)
- •Known allergy to MMC or BCG
结局指标
主要结局
Recurrence: defined as occurrence of histologically confirmed urothelial cancer recurrence of any stage or grade. Time for recurrence will be calculated from randomization date to date of biopsy/TUR-BT confirming recurrence.
Recurrence: defined as occurrence of histologically confirmed urothelial cancer recurrence of any stage or grade. Time for recurrence will be calculated from randomization date to date of biopsy/TUR-BT confirming recurrence.
次要结局
- Progression: defined as occurrence of biopsy/TUR-BT confirmed urothelial cancer with higher T-category as follows: Time for progression is calculated from randomization to the date of biopsy/TUR-BT/radiological evidence of metastasis confirming progression
研究者
Urology
Scientific
Turku University Hospital
研究点 (1)
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