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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