Actively Recruiting
Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)
Led by University of Thessaly · Updated on 2022-01-26
180
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The natural history of non-muscle-invasive bladder cancer is characterised by recurrence and progression. We compare the effectiveness of gemcitabine hydrochloride and epirubicin hydrochloride, in combination with continuous saline irrigation, as an immediate single intravesical instillation in the potential reduction of the disease recurrence as well as progression.
CONDITIONS
Official Title
Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary urinary bladder tumor
- Secondary urinary bladder tumor (recurrence)
- Bipolar or monopolar tumor resection
- Creatinine less than 2.2 mg/dl
- Hematocrit between 35% and 52%
- White blood cell count 3000 or more per microliter
- Platelet count between 75,000 and 500,000 per microliter
- Negative or sterile urine culture
- Liver enzymes (alkaline phosphatase, total bilirubin, SGOT, SGPT) up to twice the normal limit
- Good clinical condition with performance status 0 or 1
- CT Urography within 3 months showing no upper urinary tract tumor
You will not qualify if you...
- More than 2 low-grade bladder tumors in the last 18 months
- High-grade bladder tumor in the last 9 months
- Incomplete tumor resection or absence of muscle fibers in sample except certain tumor types
- Intravesical chemotherapy or BCG in last 6 months
- History of non-urothelial bladder cancer
- Muscle-invasive bladder cancer (stage pT2)
- Tumor present in the urethra
- Current or past upper urinary tract malignancy
- History of pelvic radiotherapy
- History of other cancers in last 5 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Urology Department, University of Thessaly, University Hospital of Larissa
Larissa, Larissa/Thessaly, Greece, 41110
Actively Recruiting
Research Team
V
Vasileios Tzortzis, Professor
CONTACT
L
Lampros Mitrakas, Consultant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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