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

• Status: Recruiting
• Trial end date: 2024-01-11
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Al-Azhar University
• Treatments: Gemcitabine

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).