Non-muscle invasive bladder cancer MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Intravesical solution
Other descriptive name: BCG (BACILLUS CALMETTE-GUÉRIN), LIVE ATTENUATED, STRAIN RIVM (STRAIN 1173-P2 DERIVED)
Other descriptive name: BACILLUS CALMETTE-GUÉRI
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven non-muscle-invasive tumour types confined to the urinary bladder a. Carcinoma in situ with or without a papillary tumour b. Ta tumours of high-grade c. any T1 tumours 2. Written informed consent is required from every eligible patient 3. Second-look TUR performed in case of T1 tumour 4. Adequate physical and mental condition to participate in the study, judged by responsible physician 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Urothelial cancer involving the prostatic urethra or upper urinary tract 2. Non-urothelial bladder cancer. 3. Age < 18 years 4. Pregnancy or lactating patient 5. Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by treating physician) 6. Prior BCG instillations 7. Prior or concurrent immunotherapy 8. Illness impairing the function of the immune system 9. Known allergy to MMC or BCG 10. Other untreated or unstable malignancy or malignancy in risk of recurrence/progression judged by treating physician 11. Expected poor compliance 12. Expected survival time less than one year 13. Ta low grade tumours 14. Muscle invasive (pT=2) tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate if sequential BCG/EMDA-MMC is superior to BCG monotherapy in preventing recurrences ;Secondary Objective: 1.To evaluate if sequential BCG/EMDA-MMC is superior to BCG monotherapy in preventing progression, disease specific and overall mortality 2.To evaluate side-effect profiles, tolerability and adverse effects of the different treatment options ;Primary end point(s): Recurrence;Timepoint(s) of evaluation of this end point: two years after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression Bladder cancer spesific mortality;Timepoint(s) of evaluation of this end point: two years after randomisation (progression) five years and ten years (mortality) | — |
Countries
Finland
Contacts
Public ContactTurku University Hospital
Turku University Hospital
Outcome results
None listed