Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-17 @ 4:44 PM
Study NCT ID:
NCT03058757
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
Sponsor:
National Cancer Center, Korea
Organization:
Study Overview
Official Title:
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study
Status:
COMPLETED
Status Verified Date:
2023-01
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:
The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical mitomycin-C instillation in non-muscle invasive bladder cancer patients
Detailed Description:
Study Design: Intervention Model: Single Group Assignment Masking: Open Label
Primary Outcome Measures:
Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Secondary Outcome Measures:
Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Primary Outcome Measures:
Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Secondary Outcome Measures:
Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
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?: