eoadjuvant short-term Intensive Chemoresection versus Standard Adjuvant intravesical instillations in NMIBC - A study on effect and tolerability of neoadjuvant short-term intensive chemoresection and molecular markers for prediction of chemo-response
- Conditions
- Patients with recurrent non-muscle invasive bladder cancerMedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000017467Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001189-98-DK
- Lead Sponsor
- Aarhus Universitet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
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
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
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