Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

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 ord

Trial Details

NCT ID
NCT06781879
Phase
PHASE4
Sponsor
Jakob Kristian Jakobsen
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Mitomycin c
Locations (sample)
  • Aalborg, Denmark|57.048,9.9187
  • Aarhus N, Denmark|56.20367,10.17317
  • Herlev, Denmark|55.72366,12.43998
  • Roskilde, Denmark|55.64152,12.08035
  • Reykjavik, Iceland|64.13548,-21.89541

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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