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
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
Known history of invasive tumour of the bladder (T1+)
Known history of CIS of the bladder
Previous MMC or BCG-treatment except for single instillations following previous TURBTs
Known allergy or intolerance to MMC
Parallel
Mitomycin c
DrugChemoablation
Two-year Recurrence Free Survival
This is defined as event of first recurrence following treatment but not including the recurrence diagnosed at the time of inclusion or persisting tumour following chemoablation.
Five-year RFS
This is defined as event of first recurrence following treatment but not including the recurrence diagnosed at the time of inclusion or persisting tumour following chemoablation.
Number of patients in need of a TURBT or tumour fulguration in the outpatient clinic in the first two years following randomisation
need for TURBT/fulgaration
Number of tumours at first recurrence based on the following intervals: 1, 2-7, > 8
tumour number
Number of TURBTs per patient in the first two and five years of follow-up based on the following intervals: 1, 2-5, 5-10 and multiple
number of TURBTs
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Jakob Kristian Jakobsen
Lead sponsor
Aarhus University Hospital
Sponsor institution
medac GmbH
Collaborator
Danish Cancer Society
Collaborator