RecruitingNot ApplicableNCT06167057

POST URS Chemotherapy Instillation

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


Sponsor

Carmel Medical Center

Enrollment

264 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria4

  • 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

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Interventions

DRUGMitomycin/Gemcitabine

UTUC treatment

DRUGSaline

UTUC treatment


Locations(10)

Assuta Ashdod Hospital

Ashdod, Israel

Soroka University Medical Center

Beersheba, Israel

Shamir Medical Center

Be’er Ya‘aqov, Israel

Bnai Zion Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Rambam Health Care Campus

Haifa, Israel

Rabin Medical Center - Beilinson and Hasharon

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Ziv Medical Center

Safed, Israel

Tel Aviv Sourasky Medical Center - Ichilov

Tel Aviv, Israel

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NCT06167057


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