Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462001
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2023-12-29
Brief Title:
BCG MMC Adding Mitomycin C to BCG in High-risk Non-muscle-invasive Bladder Cancer
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
BCG MMC Adding Mitomycin C to BCG as Adjuvant Intravesical Therapy for High-risk Non-muscle-invasive Bladder Cancer a Randomised Phase 3 Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
Instillation of Bacillus of Calmette-Guerin BCG into the urinary bladder intravesical administration improves rates of disease recurrence and progression after transurethral resection TUR of high risk non-muscle-invasive bladder cancer NMIBC but over 30 of people still develop recurrent transitional cell carcinoma TCC despite optimal therapy with adjuvant intravesical BCG Our meta-analysis including a recent randomised phase 2 trial suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin MM and BCG These promising findings require corroboration in a definitive large scale randomised phase 3 trial using standard techniques for intravesical administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None