Surgery and BCG in Treating Patients With Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00002990
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1288
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Dose equivalency in terms of fewer local and systemic side effects
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Ghent, Belgium
Virga Jesse Hospital
🇧🇪Hasselt, Belgium
AZ Groeninge - Oncologisch Centrum
🇧🇪Kortrijk, Belgium
Hopital Edouard Herriot
🇫🇷Lyon, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
University of Patras Medical School
🇬🇷Rio Patras, Greece
G. Hatzikosta General Hospital
🇬🇷Ioannina, Greece
Istituto Scientifico H. San Raffaele
🇮🇹Milano, Italy
Ospedale Di Desio
🇮🇹Milan, Italy
Azienda Ospedaliera Maggiore Della Carita
🇮🇹Novara, Italy
Azienda Ospedale S. Luigi - Universita Di Turin
🇮🇹Orbassano, (Torino), Italy
Universita Di Palermo
🇮🇹Palermo, Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
🇮🇹Turin, Italy
Universita Degli Studi Di Pisa
🇮🇹Pisa, Italy
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Rijnland Ziekenhuis
🇳🇱Leiderdorp, Netherlands
Amphia Ziekenhuis - locatie Langendijk
🇳🇱Breda, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
St. Franciscus Gasthuis
🇳🇱Rotterdam, Netherlands
Hospital Desterro
🇵🇹Amadora, Portugal
Institute of Oncology - Bucarest
🇷🇴Bucarest, Romania
Marmara University Hospital
🇹🇷Istanbul, Turkey
Dokuz Eylul University School of Medicine
🇹🇷Izmir, Turkey
Celal Bayar University
🇹🇷Manisa, Turkey
Gartnavel General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Pontefract General Infirmary
🇬🇧Pontefract West Yorkshire, England, United Kingdom
Freeman Hospital
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
St. James's University Hospital at Leeds Teaching Hospital NHS Trust
🇬🇧Leeds, England, United Kingdom
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands