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URO-BCG-4 : Bladder Tumors Immunotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213655
First Posted: September 21, 2005
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose
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.

Condition Intervention Phase
Bladder Cancer Biological: bladder tumor recurrence Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Tumoral response [ Time Frame: Month 36 ]
    Tumoral response assessed at M36


Secondary Outcome Measures:
  • Tumoral response [ Time Frame: Month 24 ]
    Tumoral response assessed at M24


Enrollment: 146
Study Start Date: June 2004
Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bladder Cancer
Criteria

Inclusion Criteria:

  • Ta and T1 bladder tumors

Exclusion Criteria:

  • BCG contra-indications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213655


Locations
France
Charles Nicolle, University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Christian PFISTER, MD, PhD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213655     History of Changes
Other Study ID Numbers: 2003/081/HP
First Submitted: September 14, 2005
First Posted: September 21, 2005
Last Update Posted: July 31, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases