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Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

RecruitingPhase 4Ages 18 Years - anyAllJakob Kristian Jakobsen
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 * Prior radiation therapy to the pelvic area, as radiation affects the bladder function and instillation therapy is a suboptimal treatment for this patient group * Acute cystitis * Pregnancy or breast-feeding * Averse to using secure contraception with regard to men with partners and premenopausal women
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What it tests

  • Mitomycin c
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Where

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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