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)
Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
🇧🇪Brussels, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪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
Scroll for more (30 remaining)Kaiser Franz Josef Hospital🇦🇹Vienna, Austria