URO-BCG-4 : Bladder Tumors Immunotherapy

University Hospital, Rouen

Status: Completed

Conditions: Bladder Cancer

Treatments: Biological: bladder tumor recurrence

Study type: Observational

Funder types: Other

Identifiers

NCT00213655

2003/081/HP

Details and patient eligibility

About

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.

Full 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

Enrollment: 146 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ta and T1 bladder tumors

Exclusion criteria

• BCG contra-indications

Trial design

146 participants in 2 patient groups

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

Treatment:

Biological: bladder tumor recurrence

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

Treatment:

Biological: bladder tumor recurrence