URO-BCG-4 : Bladder Tumors Immunotherapy

University Hospital, Rouen146 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

146

Conditions

Bladder Cancer

Interventions

bladder tumor recurrenceBIOLOGICAL

bladder tumor recurrence assessed by clinical and biological exams

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Ta and T1 bladder tumors Exclusion Criteria: * BCG contra-indications

Locations (1)

Charles Nicolle, University Hospital

Rouen, France

Outcomes

Primary Outcomes

Tumoral response

Tumoral response assessed at M36

Time frame: Month 36

Secondary Outcomes

Tumoral response

Tumoral response assessed at M24

Time frame: Month 24

Data from ClinicalTrials.gov

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