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NCT05671900 Clinical Trial

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

Non-muscle-invasive Bladder Cancer Clinical Trial

Official title:
The Efficacy of Sequential Intravesical Gemcitabine and Docetaxel Therapy (GEM/DOCE) in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05671900
Other study ID # 81505203284
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date December 2024

Study information
Verified date March 2024
Source Clinical Hospital Centre Zagreb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - BCG-naive patients with high-risk non-muscle invasive bladder cancer Exclusion Criteria: - patients in whome cystectomy is planned

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gemcitabine 1000 mg, Docetaxel 37.5g
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.

Locations
Country Name City State
Croatia University Hospital Centre Zagreb Zagreb

Sponsors (1)
Lead Sponsor Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reccurence free survival Patients with no bladder cancer reccurence during therapy 2 years
See also
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