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Trial registered on ANZCTR


Registration number
ACTRN12611000204943
Ethics application status
Approved
Date submitted
18/02/2011
Date registered
22/02/2011
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravesical instillation therapy for high-risk non-muscle-invasive transitional cell carcinoma of the bladder: Does the strain of Bacillus Calmette-Guerin (BCG) matter?
Scientific title
Assessment of intravesical instillation therapy with two different strains of Bacillus Calmette-Guerin (BCG) in patients with high-risk non-muscle-invasive transitional cell carcinoma of the bladder in terms of recurrence and survival.
Secondary ID [1] 259641 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-muscle-invasive transitional cell carcinoma of the bladder 261207 0
Condition category
Condition code
Cancer 259357 259357 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After completed transurethral resection of a bladder tumor (TURBT), patients diagnosed with high-risk non-muscle-invasive transitional cell carcinoma of the bladder, which qualify for a maintenance BCG therapy, are prospectively included in the trial. Patients are randomized into 2 groups: One group will use the strain BCG-Connaught (dose 1.5-5x10E8 CFU, intravesical), the other group the strain BCG-Tice (dose 5x10E8 CFU, intravesical) for the bladder instillation. Within 2 weeks after the TURBT the BCG instillation therapy is begun. A total of 6 bladder instillations are performed in weekly intervals. For the bladder instillation BCG is injected into the bladder by a single use urethral catheter. Intravesical therapy duration is 2 hours. Regular follow-up controls with cystoscopy and urine cytology are performed every 3 months during the first 3 years and then every 6 months until at least 5 years postoperatively.
Intervention code [1] 258073 0
Treatment: Drugs
Comparator / control treatment
BCG-Tice strain
Control group
Active

Outcomes
Primary outcome [1] 262170 0
Tumor recurrence by cystoscopy and urine cytology
Timepoint [1] 262170 0
Every 3 months for the first 3 years after the TURBT, then every 6 months until 5 years.
Primary outcome [2] 262171 0
Tumor progression by cystoscopy and urine cytology
Timepoint [2] 262171 0
Every 3 months for the first 3 years after the TURBT, then every 6 months until 5 years.
Secondary outcome [1] 273267 0
Overall and disease specific survival by phone call to the patient, general practitioner or the familiy.
Timepoint [1] 273267 0
at the end of the study

Eligibility
Key inclusion criteria
High-risk non-muscle-invasive transitional cell carcinoma of the bladder requiring BCG-therapy, complete resection of bladder tumors by TURBT.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Muscle-invasive transitional cell carcinoma of the bladder, incomplete resection of tumor by TURBT.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3214 0
Switzerland
State/province [1] 3214 0

Funding & Sponsors
Funding source category [1] 258535 0
Hospital
Name [1] 258535 0
Department of Urology, Inselspital Bern
Address [1] 258535 0
Anna Seiler-Haus
Inselspital
CH-3010 Bern
Country [1] 258535 0
Switzerland
Primary sponsor type
Hospital
Name
Department of Urology, Inselspital Bern
Address
Anna Seiler-Haus
Inselspital
CH-3010 Bern
Country
Switzerland
Secondary sponsor category [1] 257672 0
None
Name [1] 257672 0
Address [1] 257672 0
Country [1] 257672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260505 0
Ethics committee of the canton of Bern
Ethics committee address [1] 260505 0
Ethics committee country [1] 260505 0
Date submitted for ethics approval [1] 260505 0
Approval date [1] 260505 0
Ethics approval number [1] 260505 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32242 0
Address 32242 0
Country 32242 0
Phone 32242 0
Fax 32242 0
Email 32242 0
Contact person for public queries
Name 15489 0
Frederic Birkhaeuser
Address 15489 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 15489 0
Switzerland
Phone 15489 0
+41 31 632 36 41
Fax 15489 0
Email 15489 0
frederic.birkhaeuser@insel.ch
Contact person for scientific queries
Name 6417 0
Frederic Birkhaeuser
Address 6417 0
Department of Urology
Inselspital
Anna Seiler-Haus
CH-3010 Bern
Country 6417 0
Switzerland
Phone 6417 0
+41 31 632 36 41
Fax 6417 0
Email 6417 0
frederic.birkhaeuser@insel.ch

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary