COBRA - Chemoablation for Low Grade Bladder Cancer: A single arm, prospective, open-label, investigator-initiated Phase 2 study
Key facts
- Where
- Vienna, AusztriaSee the site
- Phase
- 2. fázis
Where in Ausztria
- Medical University of ViennaVienna, AusztriaTaking 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
- Medical University Of Vienna
- Trial code
- EU 2024-517106-28-00
- Record updated
- 2024. október 30.
- Original description
To assess efficacy of intravesical gemcitabine in patients with TaLG bladder cancerRead full original descriptionShow less
To assess efficacy of intravesical gemcitabine in patients with TaLG bladder cancer
Inclusion: 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; 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; 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 metastasi; Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
Exclusion: 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; 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; History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding; Positive human immunodeficiency virus (HIV) test; Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC; History of upper tract urothelial carcinoma (UTUC); Tumors that clinicians suspect to be HG; Patient refused to participate; Female patients who are pregnant/breastfeeding; Female patients of childbearing potential not using adequate contraception; 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.