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

Clinical Hospital Centre Zagreb

Status: Active, not recruiting

Conditions: Non-muscle-invasive Bladder Cancer

Treatments: Drug: Gemcitabine 1000 mg, Docetaxel 37.5g

Study type: Interventional

Funder types: Other

Identifiers

NCT05671900

81505203284

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• patients in whome cystectomy is planned

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

All patients

Experimental group

Description:

All patients receive same intervention throughout the trial.

Treatment:

Drug: Gemcitabine 1000 mg, Docetaxel 37.5g