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.
In this study, patients with histologically confirmed Ta low-grade bladder cancer will undergo chemoablation with gemcitabine (six weekly instillations). The study aims to evaluate the efficacy, safety, and tolerability of chemoablation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Intravesical installation
Department of Urology, Medical University of Vienna
Vienna, Austria
RECRUITINGClinical complete response (cCR)
cCR defined as negative urine cytology and absence of macroscopic tumor at the cystoscopic evaluation
Time frame: From the end of treatment (EOT) visit to the follow-up visits (1 and 3 months post-treatment).
Pathological complete response (pCR)
pCR defined as negative urine cytology, absence of macroscopic tumor at cystoscopic evaluation and confirmed by negative biopsy/TURB
Time frame: From the end of treatment visit (EOT) to the follow-up visits (1 and 3 months post-treatment).
Patient-reported Outcomes based on EORTC QLQ-NMIBC24
The global health status/quality of life endpoint will be based on the scales of EORTC QLQ-NMIBC24 questionnaire.
Time frame: Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).
Patient-reported Outcomes based on EORTC QLQ-C30
The global health status/quality of life endpoint will be based on the scales of EORTC QLQ-C30 questionnaire.
Time frame: Will be measured weekly during treatment period, at the end of treatment visit and follow-up visits (1 and 3 months post-treatment).
Ekaterina Laukhtina Dr., Medical Doctor
CONTACT
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