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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• The study will include moderate and high risk patients with NMIBC. Very high risk NMIBC patients, whom refusing radical cystectomy.
Locations
Other Locations
Egypt
Mohamed Fawzy Salman
RECRUITING
Cairo
Contact Information
Primary
Mohamed Fawzy Salman, MD
prof_mohamed_fawzy@yahoo.com
+201111788996
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2024-10-11
Participants
Target number of participants: 280
Treatments
Active_comparator: Inravesical BCG
Intravsical induction and maintenance BCG injections.
Active_comparator: Inravesical Gemcitabin
Intravsical induction and maintenance gemcitabin injections.
Related Therapeutic Areas
Sponsors
Leads: Al-Azhar University