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URO-BCG-4 : Bladder Tumors Immunotherapy

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ClinicalTrials.gov Identifier: NCT00213655
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment
Bladder Cancer Biological: bladder tumor recurrence

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
Actual Enrollment : 146 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors
Study Start Date : June 2004
Actual Primary Completion Date : May 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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




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


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



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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213655     History of Changes
Other Study ID Numbers: 2003/081/HP
First Posted: September 21, 2005    Key Record Dates
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