drugset / Trial / NCT05671900

Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer

NCT05671900

Unknown 70 enrolled Clinical Hospital Centre Zagreb
NaSingle-groupOpen-labelTreatment

Summary

Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.

Timeline

Start
2020-04-01
Primary completion
2024-06
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 37.5 mg Intravenous
Subject Gemcitabine Small molecule 1000 mg Intravenous