Urothelial cancer
Conditions
Brief summary
Number of study subjects completing all 6 induction instillations and subsequent maintenance instillations for 12 months (6+3x3)
Detailed description
Recurrence rate within 24 months in study subjects with initial complete response, Progression rate within 24 months and 60 months, disease specific survival within 24 months and 60 months, Overall survival 24 months and 60 months, Total number of BCG instillations per study subject, Number of study subjects completing all 6 induction instillations, Number of BCG instillations given with full dwell time of 2 hours per study subject, Number of instillations per study subject postsponed 1 week or more because of side effects, Number of study subjects where instillations is stopped because of local side effects, Number of study subjects where instillations is stopped because of systemic side effects, Number of study subjects undergoing re-induction therapy within 24 months because of recurrent or persistent disease
Interventions
DRUGBCG-medac Pulver und Lösungsmittel zur Herstellung einer Suspension zur intravesikalen Anwendung
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of study subjects completing all 6 induction instillations and subsequent maintenance instillations for 12 months (6+3x3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate within 24 months in study subjects with initial complete response, Progression rate within 24 months and 60 months, disease specific survival within 24 months and 60 months, Overall survival 24 months and 60 months, Total number of BCG instillations per study subject, Number of study subjects completing all 6 induction instillations, Number of BCG instillations given with full dwell time of 2 hours per study subject, Number of instillations per study subject postsponed 1 week or more because of side effects, Number of study subjects where instillations is stopped because of local side effects, Number of study subjects where instillations is stopped because of systemic side effects, Number of study subjects undergoing re-induction therapy within 24 months because of recurrent or persistent disease | — |
Countries
Denmark, Iceland, Sweden
Outcome results
None listed