Bladder liquid treatments compared in high-risk bladder cancer patients
Tests bladder-delivered BCG, alone or followed by mitomycin-C, in people with high-risk bladder cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Turku, FinlandSee the site
- Phase
- Phase 3
Where in Finland
- Turku University HospitalTurku, FinlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Turku University Hospital
- Trial code
- NCT03664869EU 2024-516320-33-00
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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; Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician); Cardiac pacemaker; Urothelial cancer involving the prostatic urethra or upper urinary tract; Non‐urothelial bladder cancer; 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; Age < 18 years; Ta low grade tumour(s); Pregnancy or lactating patient; Expected survival time less than one year; Expected poor compliance; Muscle invasive (pT≥2) tumors.