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Taking peoplePhase 4

Bladder-lining chemotherapy versus surgery for returning early bladder cancer

Tests mitomycin C inside the bladder against standard surgery in adults with recurring bladder cancer.

Key facts

Who runs it
Jakob Kristian Jakobsen
Where
Reykjavik, IcelandSee the siteAlso in 3 other countries, 7 sites
Trial code
Registry title
Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
Status
Recruiting
Phase
Phase 4
People taking part
272 people, planned
Started
1 Jun 2025
Expected to end
1 Feb 2032
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Mitomycin c
Record updated
3 October 2025

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 (Ta low-grade) has come back and is smaller than 2 cm (0.8 in). It compares chemoablation with Mitomycin C (MMC) to surgery plus instillation therapy.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Recurrent bladder tumour after an earlier Ta low-grade urothelial tumour. The tumour must be smaller than 2 cm (0.8 in) across.
Earlier treatment
No earlier MMC or BCG treatment, except single instillations after earlier TURBT (surgical removal of bladder tumours). No earlier radiation to the pelvic area.
Biomarker or test result
Negative urine cytology (a urine test for tumour cells) is listed as optional.

Main reasons for not taking part

  • Earlier invasive bladder tumour (T1 or higher)
  • Earlier or suspected carcinoma in situ (CIS) of the bladder
  • Allergy or intolerance to MMC
  • Tumour in the bladder neck or urethra
  • Pregnancy or breast-feeding

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous MMC or BCG-treatment except for single instillations following previous TURBTs
  • Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group
  • Known history of invasive tumour of the bladder (T1+)
  • Known history of CIS of the bladder
  • 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
  • Acute cystitis
  • Pregnancy or breast-feeding
  • Averse to using secure contraception with regard to men with partners and premenopausal women

Where in Iceland

Also in 3 other countries, 7 sites

  • Landspitali University HospitalReykjavik, IcelandContact: Sigurður Guðjónsson, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 order to not only be comparable to current standard, but also to improve clinical outcome and furthermore confirm the previous findings, the investigators here suggest to implement at patient tailored approach through a new multicenter RCT.

The investigators hypothesize that chemoablation with MMC in patients with recurrent Ta LG tumors will result in a permanent low recurrence rate in patients with complete response, whereas patients without complete response can be selected for adjuvant BCG which theoretically is more efficient in this select patient group. This will potentially result in a more favorable long term recurrence free survival (RFS) rate compared to the current standard regimen where all patients are treated with TURBT and adjuvant instillation therapy.

The incidence of bladder cancer in Denmark is almost 2,000 per year. Of these, 75% have non-muscle invasive bladder cancer (NMIBC). The yearly recurrence rate of NMIBC is approximately 35% and the disease is therefore one of the most costly cancers to manage on a per patient basis, due to the cost of operative procedures, follow-up cystoscopies and instillation therapies

The 2 groups in the trial

  • ChemoablationTreatment being tested

    Patients will undergo dose dense chemoablation with MMC three times per week for two weeks (six instillations in total) followed by flexible cystoscopy eight weeks later. If no tumour can be identified (complete response), patients will receive monthly MMC maintenance instillations for 6 months (six instillations in total) and then continue in the outpatient follow-up programme, according to European guidelines. If tumour regression is observed without complete response or there is no response, a TURBT or outpatient biopsy and tumour fulguration will be performed followed by adjuvant BCG with induction therapy and 1 year maintenance (6 weekly instillations as induction followed by 3 weekly instillations as maintenance at 3, 6, and 12 months or 4, 8 and 12 months as is standard for site ).

    Treatment: Mitomycin c

  • ControlNo study treatment, for comparison

    Patients will have TURBT or outpatient biopsy and tumour fulguration performed, followed by standard intravesical instillation therapy according to tumour histology: MMC once a week for six weeks with a monthly maintenance instillation for six months in low-grade tumours. For high-grade tumours BCG will be utilised once a week for six weeks followed by 1-year maintenance consisting of one weekly instillation for three weeks after 3, 6, and 12 months or 4, 8 and 12 months as is standard for site.

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 → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
Plain-language title
Bladder-lining chemotherapy versus surgery for returning early bladder cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 October 2025