Condition: Non-Muscle Invasive Bladder Cancer · Sponsor: Jakob Kristian Jakobsen
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…
This description comes directly from the study's public registry record.
Pernille Kingo, PhD, Dr · 0045 78 45 00 00 · pernking@rm.dk
Vibeke Morrison, Rn, Msc Nurs · vimorr@rm.dk
Always discuss trial participation with your own doctor first.
| Aalborg University Hospital | Aalborg, Denmark | Not Yet Recruiting |
| Aarhus University Hospital | Aarhus N, Denmark | Recruiting |
| Herlev and Gentofte Hospital | Herlev, Denmark | Recruiting |
| Zealand University Hospital, Roskilde | Roskilde, Denmark | Recruiting |
| Landspítali University Hospital | Reykjavik, Iceland | Not Yet Recruiting |
| Haukeland University Hospital | Bergen, Norway | Not Yet Recruiting |
| Vestfold Hospital Trust | Tønsberg, Norway | Not Yet Recruiting |
| NU Hospital Group | Uddevalla, Sweden | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06781879