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NCT00213655 Clinical Trial

URO-BCG-4 : Bladder Tumors Immunotherapy

Bladder Cancer Clinical Trial

Official title:
Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00213655
Other study ID # 2003/081/HP
Secondary ID
Status Completed
Phase Phase 3
First received September 14, 2005
Last updated July 30, 2014
Start date June 2004
Est. completion date December 2013

Study information
Verified date July 2014
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 146
Est. completion date December 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Ta and T1 bladder tumors

Exclusion Criteria:

- BCG contra-indications

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• bladder tumor recurrence
bladder tumor recurrence assessed by clinical and biological exams

Locations
Country Name City State
France Charles Nicolle, University Hospital Rouen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumoral response Tumoral response assessed at M36 Month 36 Yes
Secondary Tumoral response Tumoral response assessed at M24 Month 24 Yes
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