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

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

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).

Conditions2

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