Chemoablation or bladder resection with adjuvant chemotherapy in recurrent non-muscle invasive bladder cancer
Key facts
- Where
- Aalborg, Aarhus N, Herlev, Herning és Roskilde, DániaSee the 5 sites
- Phase
- 4. fázis
Where in Dánia
- Aalborg University HospitalAalborg, DániaTaking people
- Region MidtjyllandAarhus N, DániaTaking people
- Region HovedstadenHerlev, DániaTaking people
- Region MidtjyllandHerning, DániaTaking people
- Region SjaellandRoskilde, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus University
- Trial code
- EU 2022-502221-18-00
- Record updated
- 2026. április 13.
- Original description
The aim of the study is to assess if the efficacy of a dose dense chemoablation with MMC is superior regarding long term effect compared to standard treatment with TURBT and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumours.Read full original descriptionShow less
The aim of the study is to assess if the efficacy of a dose dense chemoablation with MMC is superior regarding long term effect compared to standard treatment with TURBT and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumours.
Inclusion: Tumour recurrence after previous urothelial tumour of Ta low-grade (previous Ta high-grade is allowed, but latest histology must be Ta low-grade); Largest tumour 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; The patient's mental well-being is assured.
Exclusion: Prior radiation therapy to the pelvic area; Urothelial carcinoma outside of the urinary bladder or a histological variant of urothelial carcinoma. Ta/any T1 or CIS of the upper urinary tract is allowed if treated with complete nephroureterectomy more than 24 months prior to enrolment and without any evidence of recurrence; Previous MMC or BCG-treatment within the last 3 years except for single instillations following previous TURBT or nephoureterectomy; Known history of invasive tumour of the bladder (T1+); Known immunosupressed or known autoimmune disease; Known history of CIS of the bladder; Known allergy or intolerance to MMC or BCG; 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 profuse incontinence >50 grams a day; Tumour in the bladder neck if it is visually evaluated as placed in an area being non-exposed to MMC during chemoablation; Permanent indwelling catheter if not using a valve; Non-treated Aacute cystitis at enrolment; Pregnancy or breast-feeding; Averse to using secure contraception with regard to men with partners and premenopausal women; Solid tumour with suspicions of invasion; Tumour in the urethra.