Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
Public ClinicalTrials.gov record NCT04398368. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04398368
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 25 participants
Conditions and interventions
Conditions
- Stage 0a Renal Pelvis and Ureter Cancer AJCC v8
- Stage 0a 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 I Ureter Cancer AJCC v8
- Stage II Renal Pelvis and Ureter Cancer AJCC v8
- Stage II Renal Pelvis Cancer AJCC v8
- Stage II Ureter Cancer AJCC v8
- Stage III Renal Pelvis and Ureter Cancer AJCC v8
- Stage III Renal Pelvis Cancer AJCC v8
- Stage III Ureter Cancer AJCC v8
- Stage IV Renal Pelvis and Ureter Cancer AJCC v8
- Stage IV Renal Pelvis Cancer AJCC v8
- Stage IV Ureter Cancer AJCC v8
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 4, 2020
- Primary completion
- Feb 1, 2023
- Completion
- Feb 1, 2023
- Last update posted
- Aug 7, 2023
2020 – 2023
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04398368, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 7, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04398368 live on ClinicalTrials.gov.