URO-BCG-4 : Bladder Tumors Immunotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213655
First received: September 14, 2005
Last updated: July 30, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: Yes ]
    Tumoral response assessed at M36


Secondary Outcome Measures:
  • Tumoral response [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]
    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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213655     History of Changes
Other Study ID Numbers: 2003/081/HP
Study First Received: September 14, 2005
Last Updated: July 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014