POST URS Chemotherapy Instillation

December 14, 2023 updated by: Yuval Freifeld, Carmel Medical Center

Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence

The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR.

Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either with low-risk disease or an imperative indication due to impaired renal function.

Following extirpative surgery patients are prone to IVR. Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols. In this setting, a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU.

Retrospective evidence suggests there is an increase IVR rates following URS for UTUC.

In this study the investigators seek to evaluate the efficacy of a single, post URS, bladder instillation with chemotherapy to reduce IVR.

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Ashdod, Israel
      • Be'er Sheva, Israel
      • Be'er Ya'aqov, Israel
      • Haifa, Israel, 34362
        • Recruiting
        • Carmel Medical Center
        • Contact:
        • Principal Investigator:
          • Yuval Freifeld, Dr.
      • Haifa, Israel, 31048
      • Haifa, Israel
      • Petah Tikva, Israel, 4937211
        • Recruiting
        • Rabin Medical Center - Beilinson and Hasharon
        • Contact:
      • Reẖovot, Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical Center - Ichilov
        • Contact:
      • Zefat, Israel
        • Recruiting
        • Ziv Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Radiographic and/or cytological suspicion for UTUC
  • Planned endoscopic procedure for treatment / diagnosis of UTUC
  • Patients with bladder cancer history are eligible if meeting both following criteria:

No recurrence within the last two years Are not on active bladder irrigation protocol

  • Patients with history of UTUC are eligible if last endoscopic treatment or RNU was >1 year prior to enrollment
  • Age ≥ 18 years
  • Performance status ECOG 0-2

Exclusion Criteria:

  • Subjects who have had bladder / prostate radiotherapy
  • Subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment
  • Subjects with previously treated UTUC within one year prior to enrollment
  • Subjects with metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation
Drug: Mitomycin/Gemcitabine
UTUC treatment
Placebo Comparator: B
Single post-operative 50cc Saline 0.9% bladder instillation
Drug: Saline
UTUC treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 year IVR free survival
Time Frame: 1 year
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 2 years
2 years
2 years IVR free survival
Time Frame: 2 years
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year
2 years
High grade (>3) adverse events
Time Frame: 2 years
Adverse events that are severe or medically significant but not immediately life threatening
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

January 30, 2028

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0154-22-CMC-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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