Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

NCT04865939 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: STU-2021-0402
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urothelial Cancer of Renal Pelvis; Urothelial Carcinoma Ureter

Outcome Measures

Primary Outcomes (2)

• intravesical recurrence

  rate of biopsy proven intravesical recurrence of urothelial carcinoma

  1 year

• intravesical recurrence

  rate of biopsy proven intravesical recurrence of urothelial carcinoma

  2 years

Secondary Outcomes (1)

• treatment-related associated adverse event rate

  30 days

Study Arms (2)

gemcitabine

ACTIVE COMPARATOR

intravesical instillation of gemcitabine (1 g in 50 mL saline) with dwell time of 1 - 3 hours

Drug: Gemcitabine

sterile water irrigation

EXPERIMENTAL

intravesical continuous bladder irrigation with sterile water for 1 - 3 hours and a total instilled volume of approximately 4 - 16 liters

Procedure: sterile water irrigation

Interventions

sterile water irrigation PROCEDURE

Continuous irrigation of bladder with sterile water during surgery (prior to entry into bladder).

sterile water irrigation

Gemcitabine DRUG

Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).

gemcitabine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven UTUC with plan for excisional surgery (distal ureterectomy or nephroureterectomy) with curative intent
• Age 18 - 90 years
• Life expectancy \> 1 year
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician 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 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Concurrent or prior diagnosis of bladder cancer with a disease-free interval of less than three years.
• Synchronous bilateral upper tract urothelial carcinoma (prior history of contralateral UTUC is permissible with a disease-free interval of more than three years).
• Plan for radical cystectomy.
• Small bladder capacity (\< 100 mL).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (1)

• Freifeld Y, Ghandour R, Singla N, Woldu S, Bagrodia A, Lotan Y, Rapoport LM, Gazimiev M, Delafuente K, Kulangara R, Robyak H, Petros FG, Raman JD, Matin SF, Margulis V. Intraoperative prophylactic intravesical chemotherapy to reduce bladder recurrence following radical nephroureterectomy. Urol Oncol. 2020 Sep;38(9):737.e11-737.e16. doi: 10.1016/j.urolonc.2020.05.002. Epub 2020 Jul 5.

  PMID: 32641241 BACKGROUND

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Yair Lotan, MD

CONTACT

(214) 648-0389; yair.lotan@utsouthwestern.edu

Phillip McDuffie

CONTACT

214-645-8787

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed of group allocation. Blinding treating clinicians is impractical due to the techniques used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of Urologic Oncology

Model Details: randomized, single-blinded controlled noninferiority trial

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: November 29, 2021
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2031
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)