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


Condition: Non-Muscle Invasive Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06781879

Sponsor: Jakob Kristian Jakobsen

Phase: Phase 4

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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 incontinence
  • Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group
  • Acute cystitis
  • Pregnancy or breast-feeding
  • Averse to using secure contraception with regard to men with partners and premenopausal women

View trial on ClinicalTrials.gov