MITOMYCIN for Non-muscle-invasive bladder cancer | Bladder cancer

Inclusion criteria

• {"criterion_text":"- Histologically proven non-muscle-invasive tumour types confined to the urinary bladder\n- Written informed consent is required from every eligible patient\n- Second resection performed in case of T1 tumour\n- Adequate physical and mental condition to participate in the study (as judged by treating physician"}

Exclusion criteria

• {"criterion_text":"- Ta low grade tumour(s)\n- Muscle invasive (pT≥2) tumors\n- Urothelial cancer involving the prostatic urethra or upper urinary tract\n- Non‐urothelial bladder cancer\n- 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)\n- Prior or concurrent immunotherapy\n- Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)\n- Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)\n- Known allergy to MMC or BCG\n- Age < 18 years\n- Pregnancy or lactating patient\n- Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)\n- Cardiac pacemaker\n- Expected survival time less than one year\n- Expected poor compliance"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as occurrence of histologically confirmed urothelial cancer recurrence of any stage or grade; time for recurrence calculated from randomization date to date of biopsy/TUR-BT confirming recurrence."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Defined as biopsy/TUR-BT confirmed urothelial cancer with higher T-category; time for progression calculated from randomization to date of biopsy/TUR-BT or radiological evidence of metastasis confirming progression."}

Finland

Earliest CTIS Part Ii Submission Date

09-07-2024

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

72

Number Of Sites

1

Number Of Participants

300

Primary sponsor

Full Name

Turku University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland