Non-muscle-invasive Bladder Cancer
Conditions
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.
Interventions
DRUGGemcitabine 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.
Sponsors
Clinical Hospital Centre Zagreb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BCG-naive patients with high-risk non-muscle invasive bladder cancer
Exclusion criteria
* patients in whome cystectomy is planned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reccurence free survival | 2 years | Patients with no bladder cancer reccurence during therapy |
Countries
Croatia
Outcome results
None listed