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Recruiting
NCT05626101
Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study
Conditions: Non-muscle-invasive Bladder Cancer
Sex: All
Phase: NA
Enrollment: 280
Sponsor: Al-Azhar University
Location: Egypt
Summary
About 40%-80% of NMIBC recur within 6-12 months when managed with TURBT alone, and 10%-25% of the patient's progress to muscle invasive disease.
Intravesical therapy enables delivery of high local concentrations of a therapeutic agent within the bladder, which could potentially destroy viable tumor cells that remain following TURBT
Eligibility Criteria
Inclusion Criteria:The study will include moderate and high risk patients with NMIBC.
Very high risk NMIBC patients, whom refusing radical cystectomy.Exclusion Criteria:Active UTI.Suspected bladder perforation.Hematuria.Any contraindications for gemcitabin therapy; hypersenstivity, pregnancy, an infection, hemolytic uremic syndrome, , anemia, decreased blood platelets, low levels of a type of white blood cell called neutrophils.Patients whom previously received any inravesical therapy (e.g.
prior BCG).
Source: ClinicalTrials.gov (NCT05626101). StuddyBuddy aggregates publicly available trial information.