Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388720
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-24
Brief Title:
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Study to Assess the Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy in Patients With High Risk Non-muscle Invasive Bladder Cancer NMIBC Unresponsive to BCG Therapy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
IMGeS
Brief Summary:
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients
Detailed Description:
Phase 2 clinical multi-institutional open assignment prospective study
Primary Outcome Measures
1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg20 ml and Gemcitabine 2000 mg50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups
Secondary Outcome Measures
Progression Free Survival PFS Cystectomy free survival CFS Cancer specific survival CSS Overall survival OS and safety after Mitomycin-c 40mg20ml and Gemcitabine 2000mg50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups
Primary Outcome Measures
1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg20 ml and Gemcitabine 2000 mg50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups
Secondary Outcome Measures
Progression Free Survival PFS Cystectomy free survival CFS Cancer specific survival CSS Overall survival OS and safety after Mitomycin-c 40mg20ml and Gemcitabine 2000mg50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups
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?:
False
Is an FDA AA801 Violation?:
None