Patients with recurrent non-muscle invasive bladder cancer MedDRA version: 20.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 100000017467
Conditions
Interventions
Trade Name: Mitomycin C
Product Name: Mitomycin C
Pharmaceutical Form: Powder and solvent for intravesical solution
INN or Proposed INN: MITOMYCIN
CAS Number: 50-07-7
Concentration unit: mg milligram
Sponsors
Aarhus Universitet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Known history of urothelial non-invasive Ta-tumour low-grade or high-grade. =18 years old Mentally healthy individual The ability to understand Danish orally and in writing 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: Known history of invasive tumour of the bladder (T1+) Known history of CIS of the bladder Previous BCG-treatment within the last 24 months Previous Mitomycin C-treatment (except single-shot postoperative instillation) Known allergy or intolerance to Mitomycin C Solid tumour with suspicions of invasion Single tumour of more than 2 cm in diameter Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious cystoscopy for flat lesions). Small bladder volume (less than 100 ml) or incontinence Acute cystitis Pregnancy or breast-feeding Not willing to use secure contraception with regard to men with partners and premenopausal women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to assess the efficacy of a neoadjuvant, short-term, intensive intravesical chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy. We hypothesize that the chemoresection induced in the short-term, intensive intravesical instillation with Mitomycin C will result in a permanent low recurrence rate in patients with NMIBC, not significantly different from patients treated with TURB and standard adjuvant instillation therapy. We also hypothesize that a reduction in number of TURBs will be seen in the intervention group based on avoidance of TURBs in patients with complete chemoresection by the short-term, intensive intravesical instillations. ;Secondary Objective: Primary endpoint: Number of patients in need for a reansurethral resection of the bladder (TURB) or tumour fulguration in the first 2 years following randomization. Secondary endpoints: - Adverse events related to Mitomycin C treatment during neoadjuvant or adjuvant therapy - Composition of biomarkers of 650 cancer-associated genes in order to predict tumour respons;Primary end point(s): Number of patients in need for a reansurethral resection of the bladder (TURB) or tumour fulguration in the first 2 years following randomization. ;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse events related to Mitomycin C treatment during neoadjuvant or adjuvant therapy - Composition of biomarkers of 650 cancer-associated genes in order to predict tumour respons - Number of patients in need of a TURB or tumour fulguration in the outpatient clinic in the first 5 years following randomization - 2-year recurrence free survival – not including the primary TURB in the control arm and TURB because of incomplete chemoresection in the intervention arm - 5-year recurrence free survival – not including the primary TURB in the control arm and TURB because of incomplete chemoresection in the intervention arm - Number of tumours at first recurrence based on the following intervals: 1, 2-7, > 8 - Number of TURBs per patient in the first 2 and 5 years of follow-up based on the following intervals: 1, 2-5, 5-10 and multiple - 5-year progression free survival (progression defined as progression to T1-tumour, T2+-tumour, or cystectomy irrespectively of indication) - 5-year overall survival - Fraction of patients completing assigned intervention - Gene expression-signatures of tumours before and after Mitomycin C treatment - Composition of immune cell infiltrates of tumours before and after Mitomycin C treatment ;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
Denmark
Contacts
Public ContactJørgen Bjerggaard Jensen
Aarhus Universitets Hospital
Outcome results
None listed