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Active Not Recruiting
NCT05671900
Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer
Conditions: Non-muscle-invasive Bladder Cancer
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 70
Sponsor: Clinical Hospital Centre Zagreb
Location: Croatia
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.
Eligibility Criteria
Inclusion Criteria:BCG-naive patients with high-risk non-muscle invasive bladder cancerExclusion Criteria:patients in whome cystectomy is planned
Source: ClinicalTrials.gov (NCT05671900). StuddyBuddy aggregates publicly available trial information.