Status:
COMPLETED
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
Lead Sponsor:
University Of Perugia
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progr...
Detailed Description
This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary urban teaching University Urological Department regarding sixty-four patients with high-risk superficial bladd...
Eligibility Criteria
Inclusion
- Primary diagnosis of high risk superficial bladder cancer according to EAU guidelines (http://www.eortc.be/tools/bladdercalculator/),
- Having never been treated with other intravesical chemotherapeutic agents,
- And to consent to participate to the study
Exclusion
- Concomitant tumours;
- Urinary tract infections (UTI);
- Altered function of the liver, kidneys and/or bone marrow;
- Major cardiovascular diseases;
- Life expectancy of less than 1 year;
- Intravesical chemotherapy in the previous 3 months or immunotherapy in the previous 6 months;
- Systemic chemotherapy and pelvic radiotherapy prior to TURB, and any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00696579
Start Date
January 1 2004
Last Update
June 12 2008
Active Locations (1)
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1
1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy
Perugia, Italy, 06100