Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stage 0a Renal Pelvis Cancer AJCC v8
- Stage 0a Renal Pelvis and Ureter Cancer AJCC v8
- Stage IV Renal Pelvis Cancer AJCC v8
- Stage 0a Ureter Cancer AJCC v8
- Stage 0is Renal Pelvis and Ureter Cancer AJCC v8
- Stage 0is Renal Pelvis Cancer AJCC v8
- Stage 0is Ureter Cancer AJCC v8
- Stage I Renal Pelvis and Ureter Cancer AJCC v8
- Stage I Renal Pelvis Cancer AJCC v8
- Stage III Ureter Cancer AJCC v8
- Stage IV Ureter Cancer AJCC v8
- Stage I Ureter Cancer AJCC v8
- Stage II Ureter Cancer AJCC v8
- Stage III Renal Pelvis Cancer AJCC v8
- Stage II Renal Pelvis and Ureter Cancer AJCC v8
- Stage IV Renal Pelvis and Ureter Cancer AJCC v8
- Stage II Renal Pelvis Cancer AJCC v8
- Stage III Renal Pelvis and Ureter Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 urothe...
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.
Tracking Information
- NCT #
- NCT04398368
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Stephen A Boorjian Mayo Clinic
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