URO-BCG-4 : Bladder Tumors Immunotherapy

Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00213655

Enrollment

146

Registered

2005-09-21

Start date

2004-06-30

Completion date

2013-12-31

Last updated

2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Brief 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

Interventions

BIOLOGICALbladder tumor recurrence

bladder tumor recurrence assessed by clinical and biological exams

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Ta and T1 bladder tumors

Exclusion criteria

* BCG contra-indications

Design outcomes

Primary

Measure	Time frame	Description
Tumoral response	Month 36	Tumoral response assessed at M36

Secondary

Measure	Time frame	Description
Tumoral response	Month 24	Tumoral response assessed at M24

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026