Surgery and BCG in Treating Patients With Bladder Cancer - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002990

Purpose

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
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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Surgery

Drug Information available for: BCG Vaccine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Dose equivalency with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up [ Designated as safety issue: No ]
Dose equivalency in terms of fewer local and systemic side effects [ Designated as safety issue: Yes ]

Estimated Enrollment:	1288
Study Start Date:	March 1997

Detailed Description:

OBJECTIVES:

Demonstrate that after complete transurethral resection of all papillary tumors, one third dose BCG (Bacillus Calmette-Guerin vaccine; OncoTICE) is equivalent to full dose BCG and short term maintenance is equivalent to long term maintenance with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up.
Demonstrate that one third dose BCG and short term maintenance are associated with fewer local and systemic side effects.

OUTLINE: This is a prospective randomized study.

At 7-15 days after transurethral resection, patients will begin receiving one of the following four regimens:

Regimen 1: One third dose Bacillus Calmette-Guerin (BCG) vaccine plus short term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12.
Regimen 2: Full dose BCG plus short term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12.
Regimen 3: One third dose BCG plus long term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30 and 36.
Regimen 4: Full dose BCG plus long term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30, and 36.

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.

Eligibility

Ages Eligible for Study:	up to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed transitional cell carcinoma of the bladder of the following types:
- Multiple (not greater than 10), resectable, T1 or Ta, grade G1-G3
- Solitary T1 GIII tumor

PATIENT CHARACTERISTICS:

Age:

85 and under

Performance status:

WHO 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Values used to evaluate function may not exceed two times the upper limit of normal

Renal:

Values used to evaluate function may not exceed two times the upper limit of normal

Other:

No second malignancy except basal cell skin carcinoma
Not pregnant or nursing
No uncontrollable urinary tract infection
No active tuberculosis
No HIV antibody
No leukemia
No Hodgkin's disease
No transplant recipients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior treatment with BCG

Chemotherapy:

No cytostatic agents within the past 3 months

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002990

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Locations

Austria
Kaiser Franz Josef Hospital
Vienna, Austria, A-1100
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
AZ Groeninge - Oncologisch Centrum
Kortrijk, Belgium, 8500
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Institut Jules Bordet
Brussels, Belgium, 1000
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, B-9300
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
Virga Jesse Hospital
Hasselt, Belgium, 3500
France
Hopital Edouard Herriot
Lyon, France, 69437
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Greece
G. Hatzikosta General Hospital
Ioannina, Greece, 45001
University of Patras Medical School
Rio Patras, Greece, GR-26500
Israel
Rabin Medical Center - Beilinson Campus
Petah-Tikva, Israel, 49100
Italy
Azienda Ospedale S. Luigi - Universita Di Turin
Orbassano, (Torino), Italy, 10043
Azienda Ospedaliera Maggiore Della Carita
Novara, Italy, 28100
Universita Degli Studi Di Pisa
Pisa, Italy, 56126
Istituto Scientifico H. San Raffaele
Milano, Italy, 20132
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Ospedale Di Desio
Milan, Italy, 20033
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, Italy, 10126
Universita Di Palermo
Palermo, Italy, 90145
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Amphia Ziekenhuis - locatie Langendijk
Breda, Netherlands, 4810 EV
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 NL
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Rijnland Ziekenhuis
Leiderdorp, Netherlands, 2350 CC
St. Franciscus Gasthuis
Rotterdam, Netherlands, 3045 PM
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Portugal
Hospital Desterro
Amadora, Portugal, P-2700
Romania
Institute of Oncology - Bucarest
Bucarest, Romania, RO 72435
Turkey
Celal Bayar University
Manisa, Turkey, 45010
Dokuz Eylul University School of Medicine
Izmir, Turkey, 35340
Marmara University Hospital
Istanbul, Turkey, 81190
United Kingdom, England
Freeman Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Pontefract General Infirmary
Pontefract West Yorkshire, England, United Kingdom, WF8 1PL
St. James's University Hospital at Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS9 7TF
United Kingdom, Scotland
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom, G12 0YN

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

A. P.M. Van Der Meijden, MD, PhD

Jeroen Bosch Ziekenhuis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 27, 2009