Adjuvant instillations in intermediate risk NMIBC: A Study comparIng Gemcitabine and MitomYciN (SIGYN-trial)
Phase 1
- Conditions
- Primary or recurrent non-muscle invasive bladder cancer with intermediate risk of recurrence after transurethral tumour resectionTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-001728-33-SE
- Lead Sponsor
- Region Skåne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
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
Age below 18 years of age
lack of informed consent
Known allergy to either mitomycin or gemcitabine
Severe incontinence
Cronic urethral catheter
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method