Bladder Cancer Clinical Trial
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
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.
Status | Completed |
Enrollment | 1288 |
Est. completion date | |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 85 Years |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Kaiser Franz Josef Hospital | Vienna | |
Belgium | Onze Lieve Vrouw Ziekenhuis Aalst | Aalst | |
Belgium | Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels | |
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
Belgium | Institut Jules Bordet | Brussels | |
Belgium | Universitair Ziekenhuis Gent | Ghent | |
Belgium | Virga Jesse Hospital | Hasselt | |
Belgium | AZ Groeninge - Oncologisch Centrum | Kortrijk | |
France | Hopital Edouard Herriot | Lyon | |
France | Hopitaux Universitaire de Strasbourg | Strasbourg | |
Greece | G. Hatzikosta General Hospital | Ioannina | |
Greece | University of Patras Medical School | Rio Patras | |
Israel | Rabin Medical Center - Beilinson Campus | Petah-Tikva | |
Italy | Ospedale Di Desio | Milan | |
Italy | Istituto Scientifico H. San Raffaele | Milano | |
Italy | Azienda Ospedaliera Maggiore Della Carita | Novara | |
Italy | Azienda Ospedale S. Luigi - Universita Di Turin | Orbassano, (Torino) | |
Italy | Universita Di Palermo | Palermo | |
Italy | Universita Degli Studi Di Pisa | Pisa | |
Italy | Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Turin | |
Italy | Ospedale di Circolo e Fondazione Macchi | Varese | |
Netherlands | Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | |
Netherlands | Academisch Medisch Centrum | Amsterdam | |
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Amphia Ziekenhuis - locatie Langendijk | Breda | |
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Rijnland Ziekenhuis | Leiderdorp | |
Netherlands | Academisch Ziekenhuis Maastricht | Maastricht | |
Netherlands | University Medical Center Nijmegen | Nijmegen | |
Netherlands | St. Franciscus Gasthuis | Rotterdam | |
Netherlands | University Medical Center Rotterdam at Erasmus Medical Center | Rotterdam | |
Portugal | Hospital Desterro | Amadora | |
Romania | Institute of Oncology - Bucarest | Bucarest | |
Turkey | Marmara University Hospital | Istanbul | |
Turkey | Dokuz Eylul University School of Medicine | Izmir | |
Turkey | Celal Bayar University | Manisa | |
United Kingdom | Gartnavel General Hospital | Glasgow | Scotland |
United Kingdom | St. James's University Hospital at Leeds Teaching Hospital NHS Trust | Leeds | England |
United Kingdom | Freeman Hospital | Newcastle-Upon-Tyne | England |
United Kingdom | Pontefract General Infirmary | Pontefract West Yorkshire | England |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Austria, Belgium, France, Greece, Israel, Italy, Netherlands, Portugal, Romania, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | ||
Primary | Dose equivalency in terms of fewer local and systemic side effects | Yes |
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