2022-502221-18-00RecruitingPhase 4
Chemoablation or bladder resection with adjuvant chemotherapy in recurrent non-muscle invasive bladder cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 15 May 2024
- Start date
- 26 May 2025
- Lead sponsor
- Aarhus University
- Diseases
- Bladder cancer
- EU CT number
- 2022-502221-18-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 240
- 9 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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.
- 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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Recruiting |
| Region Midtjylland | Aarhus N | Denmark | Recruiting |
| Region Hovedstaden | Herlev | Denmark | Recruiting |
| Region Midtjylland | Herning | Denmark | Recruiting |
| Region Sjaelland | Roskilde | Denmark | Recruiting |
| Landspitali | Reykjavik | Iceland | Not yet recruiting |
| Helse Bergen HF | Bergen | Norway | Recruiting |
| Sykehuset I Vestfold HF | Toensberg | Norway | Recruiting |
| NU Hospital Group-Vastra Gotalandsregionen | Trollhattan | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.