Bladder Cancer
Conditions
Brief summary
This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).
Interventions
Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is not of childbearing potential and signed informed consent. * Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.
Exclusion criteria
* The subject was previously included in this study. * The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS). * The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence. * The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract. * The subject has gross haematuria. * The subject has a history of porphyria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of bladder cancer recurrence | 12 Months |
Countries
France
Outcome results
None listed