Clinical trial · Observational
URO-BCG-4 : Bladder Tumors Immunotherapy
Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors
NCT00213655CI-TRIAL-00015266completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bladder tumor recurrence | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Daily instillation of BCG for 3 weeks then every 6 months
- description
- 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
- interventionNames
- Biological: bladder tumor recurrence
- label
- Daily instillation of BCG for 2 weeks then every 3 months
- description
- 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
- interventionNames
- Biological: bladder tumor recurrence
Primary outcomes (1)
- measure
- Tumoral response
- timeFrame
- Month 36
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Ta and T1 bladder tumors Exclusion Criteria: * BCG contra-indications
References
Publications (0)
Data not yet available
No reference posted for this study.