Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003779
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
1999-11-01
Brief Title:
Biological Therapy in Treating Patients With Bladder Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
A Prospective Randomized Trial for the Comparison of Two BCG Strains Bacille Calmette-Guerin in the Prophylaxis of Papollary Bladder Tumors Stage Ta and T1 and Treatment of Carcinoma in Situ
Status:
COMPLETED
Status Verified Date:
2019-06
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 It is not yet known which type of BCG is more effective for bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different types of BCG in treating patients who have bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different types of BCG in treating patients who have bladder cancer
Detailed Description:
OBJECTIVES I Compare two strains of BCG Connaught vs Tice in terms of efficacy yearly relapse rate and tolerability in patients with Ta or T1 papillary carcinoma of the urinary bladder or carcinoma in situ of the urinary bladder II Assess the role of prior exposition to mycobacteria vaccinationTbc for BCG treatment efficacy in these patients III Define the role of fever occurrence as a potential indicator for BCG reactivity in these patients IV Evaluate the p53 status of the resected tumors and IL-8 secretion into the urine as predictive factors of BCG reactivity in these patients V Evaluate disease free interval and disease free survival time to progression and overall survival in these patients VI Evaluate quality of life in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center T stage Ta vs T1 vs CIS and BCG immunization status positive ie greater than 10 mm diameter vs negative-indeterminate ie less than 10 mm diameter All patients undergo complete transurethral resection TURB to remove bladder tumors A Mantoux test is performed Patients with stage T1 disease undergo a second resection within 2-4 weeks after initial TURB Patients are randomized to receive either BCG Onko-Tice arm I or BCG Connaught arm II Both arms receive BCG by catheter beginning 2-14 days after the last TURB Patients must hold the BCG in the bladder for 2 hours BCG is instilled once a week for 6 weeks Quality of life is assessed before randomization daily during first and last weeks of treatment every 6 months for the first 2 years and then annually thereafter Patients are followed every 6 months for the first 3 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 300 patients will be accrued for this study within 6 years
OUTLINE This is a randomized multicenter study Patients are stratified according to center T stage Ta vs T1 vs CIS and BCG immunization status positive ie greater than 10 mm diameter vs negative-indeterminate ie less than 10 mm diameter All patients undergo complete transurethral resection TURB to remove bladder tumors A Mantoux test is performed Patients with stage T1 disease undergo a second resection within 2-4 weeks after initial TURB Patients are randomized to receive either BCG Onko-Tice arm I or BCG Connaught arm II Both arms receive BCG by catheter beginning 2-14 days after the last TURB Patients must hold the BCG in the bladder for 2 hours BCG is instilled once a week for 6 weeks Quality of life is assessed before randomization daily during first and last weeks of treatment every 6 months for the first 2 years and then annually thereafter Patients are followed every 6 months for the first 3 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 300 patients will be accrued for this study within 6 years
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 |
|---|---|---|---|
| EU-98075 | OTHER | SAKK | None |
| SWS-SAKK-0698 | OTHER | None | None |