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

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jørgen Bjerggaard Jensen
• Treatments: Mitomycin; Mitomycins

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

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