UnknownNot Applicable

Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study

Egypt280 participantsStarted 2021-01-01

Plain-language 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

Who can participate

SexALL

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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).

What they're measuring

Recurrence free survival (RFS)

Timeframe: 2 YEARS

Progression free survival (PFS)

Timeframe: 2 YEARS

Trial details

NCT IDNCT05626101

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

Contact for this trial

Mohamed Fawzy Salman, MD

+201111788996 prof_mohamed_fawzy@yahoo.com

View on ClinicalTrials.gov More Non-muscle-invasive Bladder Cancer trials