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)
- Conditions
- Bladder cancer
- Registration Number
- 2024-516320-33-00
- Lead Sponsor
- Turku University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Turku University Hospital
🇫🇮Turku, Finland
Turku University Hospital🇫🇮Turku, FinlandPeter BoströmSite contact+35823135925peter.bostrom@varha.fi