Electromotive Mitomycin-C (EMDA-MMC) in Preventing Recurrences in High-risk Non-muscle-invasive Bladder Cancer (FB10)
Bladder Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, recurrence, BCG, mitomycin C, electromotive drug administration
Eligibility Criteria
Inclusion Criteria:
- Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
- Carcinoma in situ with or without a papillary tumour(s)
- Ta tumour(s) of high-grade
- Any T1 tumour(s)
- 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 Criteria:
- Ta low grade tumour(s)
- Muscle invasive (pT≥2) tumors
- Urothelial cancer involving the prostatic urethra or upper urinary tract
- Non-urothelial bladder cancer.
- Prior BCG failure (If the 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
- 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
Sites / Locations
- HYKS Peijas HospitalRecruiting
- Jyväskylä Central HospitalRecruiting
- Päijät-Häme Central hospitalRecruiting
- Mikkeli Central HospitalRecruiting
- Seinäjoki Central HospitalRecruiting
- Tampere University HospitalRecruiting
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group A
Group B
BCG instillation therapy with induction period of six weekly instillations of BCG followed by maintenance period of ten monthly instillations of BCG Dosage of Bacillus of Calmette-Guerin (BCG) is dependent on the preferred brand of BCG by the participating institution. Either 2 x 10^8 - 3 x 10^9 for BCG-MEDAC, 2-8 x 10^8 colony forming unit for OncoTICE or, 81mg for ImmuCYST and TheraCys. The investigators will nominate which BCG brand is used.
Sequential BCG and EMDA mitomycin C treatment with nine weekly instillations of BCG, BCG, EMDA-MMC x3 followed by nine monthly instillations of EMDA-MMC, EMDA-MMC, BCG x3 Dosage of Bacillus of Calmette-Guerin (BCG) is dependent on the preferred brand of BCG by the participating institution. Either 2 x 10^8 - 3 x 10^9 for BCG-MEDAC, 2-8 x 10^8 colony forming unit for OncoTICE or, 81mg for ImmuCYST and TheraCys. The investigators will nominate which BCG brand is used. Mitomycin C dosage is 40 mg of MMC with 960 mg of excipient sodium chloride dissolved in 100 ml sterile water