Actively Recruiting
Chemoablation or Bladder Resection with Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
Led by Jakob Kristian Jakobsen · Updated on 2025-10-03
272
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
Sponsors
J
Jakob Kristian Jakobsen
Lead Sponsor
M
medac GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for patients with recurrent non-muscle invasive bladder cancer, specifically those with Ta low-grade tumors that have returned after previous treatment. This randomized, multinational Phase 4 study aims to compare the long-term effectiveness of dose-dense chemoablation using Mitomycin C (MMC) combined with adjuvant BCG against the current standard treatment involving transurethral resection of bladder tumors (TURBT) and intravesical instillation therapy. The study follows previous promising findings from the NICSA trial and seeks to improve clinical outcomes by tailoring treatment to patient response. Participants in the experimental group will receive MMC chemoablation three times a week for two weeks (six total instillations), followed by a cystoscopy eight weeks later. Those who show complete tumor response will continue with monthly MMC maintenance instillations for six months before joining regular follow-up care. Patients without complete response will undergo TURBT or biopsy with tumor fulguration, followed by adjuvant BCG induction and maintenance therapy. The control group will receive TURBT or biopsy followed by standard intravesical therapy: MMC weekly for six weeks plus monthly maintenance for low-grade tumors or BCG weekly for six weeks plus one-year maintenance for high-grade tumors. During the study, participants will be monitored for tumor recurrence through cystoscopies and other assessments over two and five years. Researchers will measure outcomes such as two-year and five-year recurrence-free survival, progression-free survival, overall survival, the number of surgeries required, and serious adverse events related to MMC treatment. The trial will last several years, with long-term follow-up to understand how well the treatments prevent tumor return and improve patient outcomes.
CONDITIONS
Brief Title
Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor recurrence after previous urothelial tumor of Ta low-grade
- Tumors smaller than 2 cm in diameter
- Negative urine cytology (optional)
- 18 years of age or older
- Ability to understand and comprehend the provided written and oral information
- Provided written informed consent
You will not qualify if you...
- Known history of invasive bladder tumor (T1 or higher)
- Known history of carcinoma in situ (CIS) of the bladder
- Previous Mitomycin C or BCG treatment except for single instillations after previous TURBTs
- Known allergy or intolerance to Mitomycin C
- Presence of solid tumor suspicious for invasion
- Tumor located in bladder neck or urethra
- Suspicion of CIS (positive cytology with high-grade neoplastic cells and suspicious flat lesions)
- Small bladder volume (less than 100 ml) or incontinence
- Prior radiation therapy to pelvic area
- Acute cystitis
- Pregnancy or breastfeeding
- Avoidance of secure contraception for men with partners and premenopausal women
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 months including maintenance treatment
Participants receive chemoablation with Mitomycin C three times per week for two weeks, followed by a flexible cystoscopy eight weeks later. Depending on response, further treatments include monthly maintenance instillations or bladder resection with adjuvant chemotherapy.
Six instillations over two weeks, followed by monthly instillations for 6 months if complete response; additional treatments as needed based on response
Duration - Up to 5 years
Participants continue in an outpatient follow-up program according to European guidelines to monitor recurrence and progression.
Regular outpatient follow-up visits as per standard care
Trial Site Locations
Total: 8 locations
1
Aalborg University Hospital
Aalborg, Denmark
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
3
Herlev and Gentofte Hospital
Herlev, Denmark
Actively Recruiting
4
Zealand University Hospital, Roskilde
Roskilde, Denmark
Actively Recruiting
5
Landspítali University Hospital
Reykjavik, Iceland
Not Yet Recruiting
6
Haukeland University Hospital
Bergen, Norway
Not Yet Recruiting
7
Vestfold Hospital Trust
Tønsberg, Norway
Not Yet Recruiting
8
NU Hospital Group
Uddevalla, Sweden
Not Yet Recruiting
Research Team
P
Pernille Kingo, PhD, Dr
V
Vibeke Morrison, Rn, Msc Nurs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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