Trial Review

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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
Sex
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
6/08/1986
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
149
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.