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

NCT ID: NCT05671900

Condition: Non-muscle-invasive Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Gemcitabine
Docetaxel

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Gemcitabine 1000 mg, Docetaxel 37.5g
Description: 6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline) and subsequent monthly maintenance installations for those with no evidence of disease.
Arm group label: All patients

Other name: Sequential intravesical chemotherapy GEM/DOCE

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - BCG-naive patients with high-risk non-muscle invasive bladder cancer Exclusion Criteria: - patients in whome cystectomy is planned

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Centre Zagreb

Address:
City: Zagreb
Zip: 10000
Country: Croatia

Start date: April 1, 2020

Completion date: December 2024

Lead sponsor:
Agency: Clinical Hospital Centre Zagreb
Agency class: Other

Source: Clinical Hospital Centre Zagreb

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05671900

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