Overview

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

Status:
Active, not recruiting

Trial end date:
2024-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Clinical Hospital Centre Zagreb

Treatments:

Docetaxel
Gemcitabine

Criteria

Inclusion Criteria:

- BCG-naive patients with high-risk non-muscle invasive bladder cancer

Exclusion Criteria:

- patients in whome cystectomy is planned