Trials / Completed
CompletedNCT00213655
URO-BCG-4 : Bladder Tumors Immunotherapy
Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 146 (actual)
- Sponsor
- University Hospital, Rouen · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | bladder tumor recurrence | bladder tumor recurrence assessed by clinical and biological exams |
Timeline
- Start date
- 2004-06-01
- Primary completion
- 2013-05-01
- Completion
- 2013-12-01
- First posted
- 2005-09-21
- Last updated
- 2014-07-31
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00213655. Inclusion in this directory is not an endorsement.