Bladder Cancer Clinical Trial
Official title:
BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study
Verified date | June 2008 |
Source | University Of Perugia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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 progression rate. The aim of this research is to evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of high-risk superficial bladder cancer
Status | Completed |
Enrollment | 64 |
Est. completion date | |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | 1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy | Perugia |
Lead Sponsor | Collaborator |
---|---|
University Of Perugia |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure consists of evaluation of recurrence and progression rates as they were detected by follow-up tools. Interval before recurrence and progression were also considered primary end-points | No | ||
Secondary | Secondary endpoints were tolerability, as detected by number of patients who dropped out the study, and safety as the recording of adverse events. | Yes |
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