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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. 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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Herlev and Gentofte Hospital
Herlev, Denmark
Zealand University Hospital, Roskilde
Roskilde, Denmark
Landspítali University Hospital
Reykjavik, Iceland
Haukeland University Hospital
Bergen, Norway
Vestfold Hospital Trust
Tønsberg, Norway
NU Hospital Group
Uddevalla, Sweden
Start Date
June 1, 2025
Primary Completion Date
February 1, 2029
Completion Date
February 1, 2032
Last Updated
October 3, 2025
272
ESTIMATED participants
Mitomycin c
DRUG
Lead Sponsor
Jakob Kristian Jakobsen
Collaborators
NCT03945162
NCT05126472
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07122414