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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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05671900). StuddyBuddy aggregates publicly available trial information.