Status:

COMPLETED

URO-BCG-4 : Bladder Tumors Immunotherapy

Lead Sponsor:

University Hospital, Rouen

Conditions:

Bladder Cancer

Eligibility:

All Genders

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 PS...

Eligibility Criteria

Inclusion

  • Ta and T1 bladder tumors

Exclusion

  • BCG contra-indications

Key Trial Info

Start Date :

June 1 2004

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

146 Patients enrolled

Trial Details

Trial ID

NCT00213655

Start Date

June 1 2004

End Date

December 1 2013

Last Update

July 31 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Charles Nicolle, University Hospital

Rouen, France, 76031

URO-BCG-4 : Bladder Tumors Immunotherapy | DecenTrialz