Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03062059
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence
Sponsor:
National Cancer Center, Korea
Organization:
Study Overview
Official Title:
The Effectiveness and Safety of Intravesical Gemcitabine Instillation During Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy in Upper Urinary Tract Urothelial Carcinoma: Prospective, Phase II Study
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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 intravesical gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma.
Detailed Description:
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Outcome Measures:
Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Secondary Outcome Measures:
Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Safety of intravesical 2000mg/52.6ml gemcitabine instillation.
Masking: Open Label
Primary Outcome Measures:
Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Secondary Outcome Measures:
Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
Safety of intravesical 2000mg/52.6ml gemcitabine 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?:
False
Is an FDA AA801 Violation?: