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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002990 |
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer.
Condition | Intervention | Phase |
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Bladder Cancer |
Biological: BCG vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder |
Estimated Enrollment: | 1288 |
Study Start Date: | March 1997 |
OBJECTIVES:
OUTLINE: This is a prospective randomized study.
At 7-15 days after transurethral resection, patients will begin receiving one of the following four regimens:
The patient is followed every 3 months for the first 3 years, and every 6 months thereafter.
PROJECTED ACCRUAL: 1288 patients will be accrued for this study.
Ages Eligible for Study: | up to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the bladder of the following types:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Investigator: | A. P.M. Van Der Meijden, MD, PhD | Jeroen Bosch Ziekenhuis |
Study ID Numbers: | CDR0000065529, EORTC-30962 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002990 History of Changes |
Health Authority: | United States: Federal Government |
stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder |
BCG Vaccine Urinary Tract Neoplasm Cystocele Immunologic Factors Urinary Bladder Diseases Adjuvants, Immunologic Urinary Bladder Neoplasms Urogenital Neoplasms |
Carcinoma, Transitional Cell Urologic Neoplasms Carcinoma Urologic Diseases Carcinoma, Papillary Bladder Neoplasm Transitional Cell Carcinoma |
BCG Vaccine Neoplasms Neoplasms by Site Immunologic Factors Urologic Diseases Physiological Effects of Drugs |
Urinary Bladder Diseases Adjuvants, Immunologic Urinary Bladder Neoplasms Urogenital Neoplasms Urologic Neoplasms Pharmacologic Actions |