URO-BCG-4 : Bladder Tumors Immunotherapy
Completed
- Conditions
- Bladder Cancer
- Interventions
- Biological: bladder tumor recurrence
- Registration Number
- NCT00213655
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.
- Detailed Description
BCG maintenance immunotherapy 1/3 dose : 27 mg two randomized arms : 3 or 6 months for 36 months clinical side effects according to OMS score efficacy regarding recurrence : cytology and cystoscopy PSA, leucocyturia and N-ramp gene evaluation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
Inclusion Criteria
- Ta and T1 bladder tumors
Exclusion Criteria
- BCG contra-indications
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Daily instillation of BCG for 3 weeks then every 6 months bladder tumor recurrence Effect of daily instillation of BCG (27 mg) for 3 weeks then one instillation of BCG (27 mg) every 6 months for 36 months on bladder tumor recurrence Daily instillation of BCG for 2 weeks then every 3 months bladder tumor recurrence Effect of daily instillation of BCG (27 mg) for 2 weeks then one instillation of BCG (27 mg) every 3 months for 36 months on bladder tumor recurrence
- Primary Outcome Measures
Name Time Method Tumoral response Month 36 Tumoral response assessed at M36
- Secondary Outcome Measures
Name Time Method Tumoral response Month 24 Tumoral response assessed at M24
Trial Locations
- Locations (1)
Charles Nicolle, University Hospital
š«š·Rouen, France