Back to resultsBacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
BCG
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring BCG, Gemcitabine, Intravesical, Therapy, Superficial, Transitional, Cell carcinoma
Eligibility Criteria
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.
Sites / Locations
- 1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
2
Arm Description
Group A received BCG instillation 14 days after II look-TURB:6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.
14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Secondary endpoints were tolerability, as detected by number of patients who dropped out the study, and safety as the recording of adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00696579
Brief Title
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
Official Title
BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2008 (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Of Perugia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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
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 bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions (gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at 3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
BCG, Gemcitabine, Intravesical, Therapy, Superficial, Transitional, Cell carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Group A received BCG instillation 14 days after II look-TURB:6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.
Arm Title
2
Arm Type
Experimental
Arm Description
14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
Intervention Type
Drug
Intervention Name(s)
BCG
Intervention Description
6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary endpoints were tolerability, as detected by number of patients who dropped out the study, and safety as the recording of adverse events.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy
City
Perugia
ZIP/Postal Code
06100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
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