POST URS Chemotherapy Instillation

Last updated: December 14, 2023
Sponsor: Carmel Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Mitomycin/Gemcitabine

Saline

Clinical Study ID

NCT06167057
0154-22-CMC-C
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 >1year prior to enrollment
  • Age ≥ 18 years
  • Performance status ECOG 0-2

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 264
Treatment Group(s): 2
Primary Treatment: Mitomycin/Gemcitabine
Phase:
Study Start date:
April 17, 2023
Estimated Completion Date:
January 30, 2028

Study 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.

Connect with a study center

  • Assuta Ashdod Hospital

    Ashdod,
    Israel

    Active - Recruiting

  • Soroka University Medical Center

    Be'er Sheva,
    Israel

    Active - Recruiting

  • Shamir Medical Center

    Be'er Ya'aqov,
    Israel

    Active - Recruiting

  • Bnai Zion Medical Center

    Haifa, 31048
    Israel

    Active - Recruiting

  • Carmel Medical Center

    Haifa, 34362
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa,
    Israel

    Active - Recruiting

  • Rabin Medical Center - Beilinson and Hasharon

    Petah Tikva, 4937211
    Israel

    Active - Recruiting

  • Kaplan Medical Center

    Reẖovot,
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center - Ichilov

    Tel Aviv,
    Israel

    Active - Recruiting

  • Ziv Medical Center

    Zefat,
    Israel

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.