URO-BCG-4 : Bladder Tumors Immunotherapy

NCT ID: NCT00213655

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Bladder Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

bladder tumor recurrence

Intervention Type BIOLOGICAL

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

bladder tumor recurrence

Intervention Type BIOLOGICAL

bladder tumor recurrence assessed by clinical and biological exams

Interventions

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bladder tumor recurrence

bladder tumor recurrence assessed by clinical and biological exams

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Ta and T1 bladder tumors

Exclusion Criteria

* BCG contra-indications
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian PFISTER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Charles Nicolle, University Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2003/081/HP

Identifier Type: -

Identifier Source: org_study_id

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