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Chemoablation or bladder resection with adjuvant chemotherapy in recurrent non-muscle invasive bladder cancer
EU CTIS ID: 2022-502221-18-00
What this study is testing
The aim of the study is to assess if the efficacy of a dose dense chemoablation with MMC is superior regarding long term effect compared to standard treatment with TURBT and adjuvant intravesical instillation therapy in patients with recurrent Ta LG tumours.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Tumour recurrence after previous urothelial tumour of Ta low-grade (previous Ta high-grade is allowed, but latest histology must be Ta low-grade)
- • Largest tumour 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
- • The patient's mental well-being is assured
You likely can't join if
- • Known history of invasive tumour of the bladder (T1+)
- • 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 profuse incontinence >50 grams a day
- • Prior radiation therapy to the pelvic area
- • Tumour in the bladder neck if it is visually evaluated as placed in an area being non-exposed to MMC during chemoablation
- • Urothelial carcinoma outside of the urinary bladder or a histological variant of urothelial carcinoma. Ta/any T1 or CIS of the upper urinary tract is allowed if treated with complete nephroureterectomy more than 24 months prior to enrolment and without any evidence of recurrence
See the full eligibility criteria
- • Tumour recurrence after previous urothelial tumour of Ta low-grade (previous Ta high-grade is allowed, but latest histology must be Ta low-grade)
- • Largest tumour 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
- • The patient's mental well-being is assured
- • Known history of invasive tumour of the bladder (T1+)
- • 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 profuse incontinence >50 grams a day
- • Prior radiation therapy to the pelvic area
- • Tumour in the bladder neck if it is visually evaluated as placed in an area being non-exposed to MMC during chemoablation
- • Urothelial carcinoma outside of the urinary bladder or a histological variant of urothelial carcinoma. Ta/any T1 or CIS of the upper urinary tract is allowed if treated with complete nephroureterectomy more than 24 months prior to enrolment and without any evidence of recurrence
- • Permanent indwelling catheter if not using a valve
- • Known immunosupressed or known autoimmune disease
- • Non-treated Aacute cystitis at enrolment
- • Pregnancy or breast-feeding
- • Averse to using secure contraception with regard to men with partners and premenopausal women
- • Known history of CIS of the bladder
- • Previous MMC or BCG-treatment within the last 3 years except for single instillations following previous TURBT or nephoureterectomy
- • Known allergy or intolerance to MMC or BCG
- • Solid tumour with suspicions of invasion
- • Tumour in the urethra
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.