URO-BCG-4 : Bladder Tumors Immunotherapy

July 30, 2014 updated by: University Hospital, Rouen

Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • Charles Nicolle, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Bladder Cancer

Description

Inclusion Criteria:

  • Ta and T1 bladder tumors

Exclusion Criteria:

  • BCG contra-indications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Daily instillation of BCG for 3 weeks then every 6 months
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
Biological: bladder tumor recurrence
bladder tumor recurrence assessed by clinical and biological exams
Daily instillation of BCG for 2 weeks then every 3 months
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
Biological: bladder tumor recurrence
bladder tumor recurrence assessed by clinical and biological exams

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumoral response
Time Frame: Month 36
Tumoral response assessed at M36
Month 36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumoral response
Time Frame: Month 24
Tumoral response assessed at M24
Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Christian PFISTER, MD, PhD, Rouen University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003/081/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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