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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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05626101). StuddyBuddy aggregates publicly available trial information.