Primary or recurrent non-muscle invasive bladder cancer with intermediate risk of recurrence after transurethral tumour resection
Conditions
Interventions
Trade Name: Mitomycin Medac
Pharmaceutical Form: Powder and solvent for intravesical solution
INN or Proposed INN: MITOMYCIN
CAS Number: 50-07-7
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary och recurrent non muscle invasive bladder cancer with intermediate risk of recurrence 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: Age below 18 years of age lack of informed consent Known allergy to either mitomycin or gemcitabine Severe incontinence Cronic urethral catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate if adjuvant gemcitabine improves recurrence free survival compared to adjuvant mitomycin;Secondary Objective: Secondary objectives are local side effects and HRQoL two weeks after the last instillation, progression-free survival, health economy and adverse events;Primary end point(s): Recurrence-free survival;Timepoint(s) of evaluation of this end point: at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Local toxicity and HRQoL two weeks after last instillation Progression-free survival Health economy Adverse events ;Timepoint(s) of evaluation of this end point: See above | — |
Countries
Sweden
Contacts
Public ContactSUS Urologkliniken
Region Skåne
Outcome results
None listed