Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC

DaBlaCa13

A randomized controlled trial aiming to investigate neoadjuvant, short-term intensive chemoresection with Mitomycin C compared to standard treatment with TURB and adjuvant intravesical instillation therapy in patients with recurrent non-muscle invasive bladder cancer (NMIBC).

2017-11-01

2019-06-11

2024-12-31

Active (not recruiting)

Early phase I

120

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 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

2023-12-14