URO-BCG-4 : Bladder Tumors Immunotherapy

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Charles Nicolle, University Hospital

Rouen, 76031, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ta and T1 bladder tumors

Exclusion criteria

BCG contra-indications

Treatment and study plan

bladder tumor recurrence

Biological

bladder tumor recurrence assessed by clinical and biological exams

Primary outcomes

Tumoral response

Time frame: Month 36

Tumoral response assessed at M36

Secondary outcomes

Tumoral response

Time frame: Month 24

Tumoral response assessed at M24

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

Important dates

Study start: 2004
Primary completion: 2013
Study completion: 2013
First posted: Sep 21, 2005
Registry last updated: Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed