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Chemohyperthermia with mitomycin C versus standard intravesical mitomycin C for early recurrence in non-muscle invasive bladder cancer
2015-005151-27Phase 4
Key facts
- Status
- Active
- Start
- Mar 2016
- Countries
- 1
- Sponsor
- Hospital Universitario de Canarias
- Modality
- Small Molecules
- Drugs
- mitomycin c
- Conditions
- bladder cancer
01
Overview
Phase 4, randomised trial of mitomycin c in bladder cancer (2 arms), sponsored by Hospital Universitario de Canarias. Primary endpoint: Tumor recurrence after transurethral resection. Started Mar 2016; status: active.
02
Design
2 arms- Study design
- Randomized
Pre-resection chemohyperthermia mitomycin C
Intravesical chemohyperthermia with mitomycin C prior to transurethral resection of bladder tumor in an ambulatory surgery program, followed by routine care and long-term follow-up.
Post-resection normothermic mitomycin C
Standard intravesical mitomycin C under normothermic conditions administered after transurethral resection of bladder tumor, followed by routine care and long-term follow-up.
03
Who it enrols
Adults (age >18 years) with non-muscle invasive bladder cancer eligible for transurethral resection and intravesical mitomycin C; patients with known hypersensitivity to mitomycin C or its excipients are excluded.
04
Endpoints
Primary
Tumor recurrence after transurethral resection
Secondary
Adverse events
Predictor factors in treatment response and hospitalization
Quality of life
Sexual health
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