Tests gemcitabine placed in the bladder for low-grade bladder cancer
Tests bladder-delivered gemcitabine in adults with low-grade bladder cancer.
Plain-language title generated from the registry record
Registry title: Chemoablation for Low-Grade Bladder Cancer
Key facts
- Where
- Vienna, AustriaSee the site
- Phase
- Phase 2
Where in Austria
- Department of Urology, Medical University of ViennaVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ekaterina Laukhtina
- Trial code
- NCT07019220
- Record updated
- 13 June 2025
- Original description
The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.Read full original descriptionShow less
COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study
The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.
Inclusion: Male/female participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study; Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening; On screening cystoscopy: Diameter of the largest lesion ≤15mm; Number of lesions ≤5; Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation; Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk); NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT); Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening; No lymph node metastasis or distant metastasis; Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment; Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Female patients of childbearing potential must use adequate contraception during study period; Willing and able to provide informed consent.
Exclusion: Any previous intravesical therapy within 1 year; Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago; Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment; Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC; History of upper tract urothelial carcinoma (UTUC); History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding; Known positive human immunodeficiency virus (HIV) test; Tumors that clinicians suspect to be HG; Positive HG cytology according to Paris criteria; Diameter of tumor >15 mm; Number of lesions >5; Clinically significant urethral stricture that would preclude passage of a urethral catheter; Patient refused to participate; Female patients who are pregnant/breastfeeding; Female patients of childbearing potential not using adequate contraception.