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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily instillation of BCG for 3 weeks then every 6 months | 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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bladder tumor recurrence | Biological | bladder tumor recurrence assessed by clinical and biological exams |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumoral response | Tumoral response assessed at M36 | Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumoral response | Tumoral response assessed at M24 | Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Bladder Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Christian PFISTER, MD, PhD | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Nicolle, University Hospital | Rouen | 76031 | France |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |