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New treatment option for Non-Muscle Invasive Bladder Cancer
Official title Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT06781879
What this study is testing
What is Mitomycin c?
Mitomycin c is an investigational medicine, being studied as a potential treatment for non-muscle invasive bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus N, Denmark
- Herlev, Denmark
- Roskilde, Denmark
- Reykjavik, Iceland
- Bergen, Norway
- Tønsberg, Norway
- Uddevalla, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus N, Denmark; Herlev, Denmark; Roskilde, Denmark; Reykjavik, Iceland; Bergen, Norway and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.