Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Inva
The investigartors will conduct a randomized, multinational study with the aim to assess if the efficacy of a dose dense chemoablation with Mitomycin C (MMC) with adjuvant BCG in non-responding patients is superior regarding long term effect compared to standard treatment with trans urethral resection of bladder tumors
| Condition(s) | Non-Muscle Invasive Bladder Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The investigartors will conduct a randomized, multinational study with the aim to assess if the efficacy of a dose dense chemoablation with Mitomycin C (MMC) with adjuvant BCG in non-responding patients is superior regarding long term effect compared to standard treatment with trans urethral resection of bladder tumors (TURBT) and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumors. The study is a natural follow-up study following the pivotal NICSA trial supported by the Danish Cancer Society that has lead to the initial change in the European guidelines. In order to not only be comparable to current standard, but also to improve clinical outcome and furthermore confirm the previous findings, the investigators here suggest to implement at patient tailored app |
| Who can participate | Inclusion Criteria: * Tumour recurrence after previous urothelial tumour of Ta low-grade * Tumours smaller than 2 cm in diameter * Negative urine cytology (optional) * ≥18 years of age * Ability to understand and comprehend the provided written and oral information * Has provided written consent Exclusion Criteria: * Known history of invasive tumour of the bladder (T1+) * Known history of CIS of the bladder * Previous MMC or BCG-treatment except for single instillations following previous TURBTs * Known allergy or intolerance to MMC * Solid tumour with suspicions of invasion * Tumour in the bladder neck or urethra * Suspicion of CIS (positive cytology with high-grade neoplastic cells combined with suspicious flat lesions seen at cystoscopy) * Small bladder volume (less than 100 ml) or inco |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Jakob Kristian Jakobsen |
| Locations | Aalborg, Denmark; Aarhus N, Denmark; Herlev, Denmark; Roskilde, Denmark; Reykjavik, Iceland; Bergen, Norway (+2 more sites) |
| Start date | 2025-06-01 |
| NCT ID | NCT06781879 |
| Official listing | https://clinicaltrials.gov/study/NCT06781879 |