NCT00002990

Surgery and BCG in Treating Patients With Bladder Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,288 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BCG vaccine

Timeline

• Start date: 1997-03-01
• Primary completion: 2005-04-01
• First posted: 2003-01-27
• Last updated: 2013-06-12

Locations

40 sites across 11 countries: Austria, Belgium, France, Greece, Israel, Italy, Netherlands, Portugal, Romania, Turkey (Türkiye), United Kingdom