Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer
- Conditions
- Non-muscle-invasive Bladder Cancer
- Interventions
- Registration Number
- NCT05671900
- Lead Sponsor
- Clinical Hospital Centre Zagreb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- BCG-naive patients with high-risk non-muscle invasive bladder cancer
- patients in whome cystectomy is planned
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients Gemcitabine 1000 mg, Docetaxel 37.5g All patients receive same intervention throughout the trial.
- Primary Outcome Measures
Name Time Method Reccurence free survival 2 years Patients with no bladder cancer reccurence during therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia