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Taking people in DenmarkPhase 4

Comparing two treatments for bladder cancer that has returned

Tests a chemical treatment inside the bladder against surgery in adults with recurrent bladder cancer.

Key facts

Who runs it
Aarhus University
Where
Aalborg, Aarhus N, Herlev, Herning, and Roskilde, DenmarkSee the 5 sitesAlso in 3 other countries, 4 sites
Registry title
Chemoablation or bladder resection with adjuvant chemotherapy in recurrent non-muscle invasive bladder cancer
Status
Recruiting
Phase
Phase 4
People taking part
240 people, planned
Started
26 May 2025
Expected to end
31 Dec 2027
Type of study
Interventional
Record updated
13 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose low-grade, non-invasive bladder tumour has come back. It compares chemoablation with MMC against surgical removal (TURBT) plus chemotherapy put into the bladder.

Age
18 years or older
Sex
All sexes can join
Disease stage
Bladder tumour that came back after an earlier Ta low-grade tumour. The latest tissue result must be Ta low-grade. The largest tumour must be smaller than 2 cm (0.8 in).
Earlier treatment
Earlier Ta high-grade tumour is allowed. Earlier MMC or BCG treatment within the last 3 years cannot be used, except single instillations after earlier TURBT or nephroureterectomy. Earlier radiation to the pelvic area is not allowed.
Biomarker or test result
Negative urine cytology (optional)

Main reasons for not taking part

  • History of invasive bladder tumour (T1 or higher) or of CIS of the bladder
  • Small bladder volume (less than 100 ml) or heavy incontinence (more than 50 grams a day)
  • Known weak immune system or known autoimmune disease
  • Pregnancy or breast-feeding
  • Known allergy or intolerance to MMC or BCG

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Denmark

Also in 3 other countries, 4 sites

  • Aalborg University HospitalAalborg, DenmarkTaking people
  • Region MidtjyllandAarhus N, DenmarkTaking people
  • Region HovedstadenHerlev, DenmarkTaking people
  • Region MidtjyllandHerning, DenmarkTaking people
  • Region SjaellandRoskilde, DenmarkTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Chemoablation or bladder resection with adjuvant chemotherapy in recurrent non-muscle invasive bladder cancer
Plain-language title
Comparing two treatments for bladder cancer that has returnedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
13 April 2026