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Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

StatusRecruiting
PhasePhase 3
Started2021-11-29
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Study Status, Oversight, Contacts/Locations v12
Study sitescontacts updated at 1 of 1 site
2025-07-14
Study Status v11
Primary completion date2027-11-01→2029-11-01
Completion date2029-11-01→2031-11-01
2025-04-08
Study Identification, Study Status, Eligibility, Contacts/Locations v10
Eligibility criteria+345 characters
[...] icipation, and for 90 days following completion of therapy. FemaleShould participantsa whowoman become pregnant or who suspect thatshe they areis pregnant while participating in this study, she should notifyinform theher treating investigatorphysician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least [...] Ability to understand and the willi [...] [...]
Study sitescontacts updated at 1 of 1 site
2024-12-06
Study Identification, Study Status, Oversight, Contacts/Locations, References v9
Study sitescontacts updated at 1 of 1 site
2023-12-05
Study Status v8
Re-verified, no change to tracked fields
Show 7 earlier versions
2022-12-20
Study Status, Sponsor/Collaborators, Outcome Measures v7
Secondary endpointsdetails revised at 1 of 1 entry
2021-11-30
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-11-22→confirmed 2021-11-29
Study sitesdetails revised at 1 of 1 site
2021-11-15
Study Status v5
Primary completion date2027-10-01→2027-11-01
Completion date2029-10-01→2029-11-01
Start date2021-11→2021-11-22
2021-10-26
Study Status, Study Design v4
Re-verified, no change to tracked fields
2021-10-26
Study Status v3
Start date2021-10-01→2021-11
2021-08-04
Study Status, Study Design v2
Primary completion date2027-08-01→2027-10-01
Completion date2029-08-01→2029-10-01
Start date2021-08-01→2021-10-01
Enrollment target110→132
2021-04-29
Study Status, Study Description, Eligibility v1
Eligibility criteria-16 characters
[...] icipation, and for 90 days following completion of therapy. ShouldFemale aparticipants womanwho become pregnant or who suspect shethat isthey are pregnant while participating in this study, she should informnotify herthe treating physicianinvestigator immediately. Ability to understand and the willingness to s [...]
Study description+39 characters
[...] Moriarty et al. with no directly associated adverse events. WeThe investigators' group also compared bladder recurrence rates in patients who received intraoperative or postoperative pIVC. In ourthis cohort, 12- and 24-month recurrence rates in the I-pIVC gro [...] % and 14.4%, respectively, with a favorable safety profile. Our own currentCurrent practice at this institution, which is widely employed at many centers but is not suppor [...] in comparison to the saline or water groups. In this study, weit hypothesizeis hypothesized that intraoperative continuous bladder irrigation with ster [...]
2021-04-26
Original filing
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.
Trial Details
NCT Number NCT04865939
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma Ureter
Enrollment 132 participants
Start Date 2021-11-29
Primary Completion 2029-11-01 (estimated)
Study Completion 2031-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-17