Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
Study NCT ID:
NCT04398368
Status:
TERMINATED
Last Update Posted:
2023-08-08
First Post:
2020-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
GEMINI: An Open-Label, Single-Arm, Phase II Study of Intraoperative Gemcitabine Intravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma
Status:
TERMINATED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Focus research efforts on other projects.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well gemcitabine works in preventing urothelial cancer from coming back within the bladder (intravesical recurrence) in patients with upper urinary tract urothelial cancer undergoing radical nephroureterectomy. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Instilling gemcitabine into the bladder during surgery, may reduce the chance of recurrence of upper urinary tract urothelial cancer.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the efficacy of a single intraoperative intravesical instillation of gemcitabine hydrochloride (gemcitabine) at time of radical nephroureterectomy (RNU) for clinically localized upper tract urothelial carcinoma (UTUC) in preventing intravesical recurrence of urothelial cancer (UC) at one year.
SECONDARY OBJECTIVES:
I. To assess time to recurrence for entire duration of follow-up. II. To assess the qualitative and quantitative toxicities.
EXPLORATORY OBJECTIVES:
I. To stratify intravesical UC recurrence free survival by tumor grade, neoadjuvant chemotherapy, tumor stage, ureteral tumor location, and history of bladder cancer.
II. To assess incidence and time to development of muscle-invasive bladder cancer (MIBC).
OUTLINE:
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
After completion of study, patients are followed up at 2 weeks, and 3, 6, 12, 18, and 24 months.
I. To determine the efficacy of a single intraoperative intravesical instillation of gemcitabine hydrochloride (gemcitabine) at time of radical nephroureterectomy (RNU) for clinically localized upper tract urothelial carcinoma (UTUC) in preventing intravesical recurrence of urothelial cancer (UC) at one year.
SECONDARY OBJECTIVES:
I. To assess time to recurrence for entire duration of follow-up. II. To assess the qualitative and quantitative toxicities.
EXPLORATORY OBJECTIVES:
I. To stratify intravesical UC recurrence free survival by tumor grade, neoadjuvant chemotherapy, tumor stage, ureteral tumor location, and history of bladder cancer.
II. To assess incidence and time to development of muscle-invasive bladder cancer (MIBC).
OUTLINE:
Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.
After completion of study, patients are followed up at 2 weeks, and 3, 6, 12, 18, and 24 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: