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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with low-grade, non-muscle-invasive bladder cancer (TaLG) that is new or has come back, with small and few tumors. It tests chemoablation placed inside the bladder.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Primary or recurrent TaLG non-muscle-invasive bladder cancer (low or intermediate EAU risk), confirmed by biopsy. The largest tumor is 15 mm or smaller. There are 5 tumors or fewer. No spread to lymph nodes or other organs.
- Earlier treatment
- No treatment placed inside the bladder within the last year. No high-grade non-muscle-invasive bladder cancer within the last 3 years.
- Biomarker or test result
- Urine cell test (voiding cytology) negative for high-grade disease within 8 weeks before screening.
Main reasons for not taking part
- Tumors thought to be high grade, or a positive high-grade urine cell test
- Tumor larger than 15 mm, or more than 5 tumors
- Past or current muscle-invasive or metastatic bladder cancer, or upper tract urothelial cancer
- Known positive HIV test
- Pregnant or breastfeeding women, or women who can have children and do not use adequate contraception
Read by machine on 12 November 2026.
Where in Austria
- Department of Urology, Medical University of ViennaVienna, AustriaContact: Ekaterina Laukhtina Dr., Medical DoctorTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.