Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002990
Status:
COMPLETED
Last Update Posted:
2013-06-12
First Post:
1999-11-01
Brief Title:
Surgery and BCG in Treating Patients With Bladder Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 13 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 13 Dose Short-Term Maintenance in Intermediate and High Risk Ta T1 Papillary Carcinoma of the Urinary Bladder
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-30962 | None | None | None |