Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04865939 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma
A Phase 3 study of Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma Ureter, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04865939: Recruiting Phase 3 study of Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma Ureter, sponsored by University of Texas Southwestern Medical Center.
NCT04865939 is a Phase 3 study of Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma Ureter that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 132 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04865939, a Phase 3 study of Urothelial Cancer of Renal Pelvis and Urothelial Carcinoma Ureter, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
There is a high rate of intravesical (bladder) recurrence following extirpative surgery for upper tract urothelial carcinoma. There is no single established standard of care for prevention of intravesical recurrence; however, one protocol in common use involves the use of intravesical gemcitabine instilled into the bladder during surgery and prior to entry into the bladder. There are barriers to the use of gemcitabine, especially at lower volume centers. Some evidence suggests that intravesical irrigation with sterile water has equivalent efficacy to intravesical chemotherapy in prevention of recurrent bladder cancer following transurethral resection of bladder tumors (TURBT). This study is intended to compare recurrence rates using intravesical gemcitabine (as a pseudo-standard of care) and continuous bladder irrigation with sterile water.
Primary Outcome
rate of biopsy proven intravesical recurrence of urothelial carcinoma
Conditions Studied
Interventions
- DRUG Gemcitabine
- PROCEDURE sterile water irrigation
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2031-11-01 |
| Phase | Phase 3 |
What NCT04865939 shows while recruiting
NCT04865939 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Urothelial Cancer of Renal Pelvis appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT04865939 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04865939 about?
NCT04865939 is a clinical study titled "Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma". There is a high rate of intravesical (bladder) recurrence following extirpative surgery for upper tract urothelial carcinoma. There is no single established standard of care for prevention of intravesical recurrence; however, one protocol in common use involves the use of intravesical gemcitabine in...
What is the current status of trial NCT04865939?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 132 participants. The study started on 2021-11-29. Estimated completion is 2031-11-01.
What conditions does trial NCT04865939 study?
This clinical trial studies the following conditions: Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma Ureter.
What interventions are being tested in trial NCT04865939?
The interventions under investigation include: Gemcitabine (DRUG), sterile water irrigation (PROCEDURE).
Who is sponsoring clinical trial NCT04865939?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04865939 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Urothelial Cancer of Renal Pelvis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04865939's enrollment target sits among peer trials
132 1589th of 2000 higher than 408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01766297 · 132 participants · Phase 2
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- NCT04002947 · 132 participants · Phase 2
Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma
- NCT04128189 · 132 participants · Phase 3
Shingrix in Renal Transplant Recipients
- NCT04199780 · 132 participants · NA
Effects of tDCS Combined With CBI on Postsurgical Pain
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI