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Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors


Phase 3
N/A
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors


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


Inclusion Criteria:



- Ta and T1 bladder tumors

Exclusion Criteria:

- BCG contra-indications

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Christian PFISTER, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rouen University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2003/081/HP

NCT ID:

NCT00213655

Start Date:

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms

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