Bladder cancer
Conditions
Interventions
Pharmaceutical Form: Powder for solution for infusion
Other descriptive name: Gemcitabine hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 Version 1.1; 04.12.2022 - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: - Tumors that clinicians suspect to be HG - Positive HG cytology according to Paris criteria - Diameter of tumor >15 mm - Number of lesions >5 - Any previous intravesical therapy within 1 year - Previous HG NMIBC - Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC - History of upper tract urothelial carcinoma (UTUC) - Clinically significant urethral stricture that would preclude passage of a urethral catheter - History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding - 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 - Patient refused to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy of intravesical gemcitabine in patients with bladder cancer;Secondary Objective: To assess safety and tolerability of intravesical gemcitabine in patients with bladder cancer ;Primary end point(s): Clinical complete response (cCR, absence of the macroscopic tumor after chemoablation);Timepoint(s) of evaluation of this end point: N/A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pathological complete response (pCR) Overall response (cCR + pCR) Safety (AEs and TRAEs) Rate of treatment discontinuation (at least 5 from 6 instillations within 8 weeks) Clinical response of photo review by external independent blinded committee Health-related quality of life (EORTC QLQ-NMIBC24 and EORTC QLQ-C30);Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Austria
Contacts
Public ContactDepartement of Urology
Medical University of Vienna
Outcome results
None listed