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Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT04865939
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : December 22, 2022
Information provided by (Responsible Party):
yair lotan, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Urothelial Cancer of Renal Pelvis Urothelial Carcinoma Ureter Procedure: sterile water irrigation Drug: Gemcitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, single-blinded controlled noninferiority trial
Masking: Single (Participant)
Masking Description: Participants will not be informed of group allocation. Blinding treating clinicians is impractical due to the techniques used.
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Intravesical Gemcitabine to Continuous Bladder Irrigation With Sterile Water to Prevent Bladder Cancer Implantation in Patients Undergoing Excision of Upper Tract Urothelial Carcinoma
Actual Study Start Date : November 29, 2021
Estimated Primary Completion Date : November 1, 2027
Estimated Study Completion Date : November 1, 2029

Arm Intervention/treatment
Active Comparator: gemcitabine
intravesical instillation of gemcitabine (1 g in 50 mL saline) with dwell time of 1 - 3 hours
Drug: Gemcitabine
Intravesical gemcitabine instilled into bladder during surgery (drained prior to entry into bladder).

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

Primary Outcome Measures :
  1. intravesical recurrence [ Time Frame: 1 year ]
    rate of biopsy proven intravesical recurrence of urothelial carcinoma

  2. intravesical recurrence [ Time Frame: 2 years ]
    rate of biopsy proven intravesical recurrence of urothelial carcinoma

Secondary Outcome Measures :
  1. treatment-related associated adverse event rate [ Time Frame: 30 days ]
    rate of CTCAE grade 1-3 complications

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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. Female participants who become pregnant or who suspect that they are pregnant should notify the treating investigator immediately.
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • 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.
  • 3.2.4 Suspicion for small bladder capacity (< 100 mL) based on treating urologist's clinical judgment.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or other agents used in study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865939

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Contact: Yair Lotan, MD (214) 648-0389 yair.lotan@utsouthwestern.edu

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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Yair Lotan, MD    214-648-0389    yair.lotan@utsouthwestern.edu   
Principal Investigator: Yair Lotan, MD         
Sub-Investigator: Vitaly Margulis, MD         
Sub-Investigator: Aditya Bagrodia, MD         
Sub-Investigator: Jeffrey M Howard, MD, PhD         
Sub-Investigator: Xiaosong Meng, MD, PhD         
Sub-Investigator: Solomon L Woldu, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Responsible Party: yair lotan, Professor and Chief of Urologic Oncology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04865939    
Other Study ID Numbers: STU-2021-0402
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs