Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06167057

POST URS Chemotherapy Instillation

Led by Carmel Medical Center · Updated on 2023-12-20

264

Participants Needed

10

Research Sites

249 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

POST URS Chemotherapy Instillation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Radiographic and/or cytological suspicion for UTUC
  • Planned endoscopic procedure for treatment or diagnosis of UTUC
  • Patients with bladder cancer history are eligible if they have had no recurrence within the last two years and are not on active bladder irrigation protocol
  • Patients with history of UTUC are eligible if their last endoscopic treatment or radical nephroureterectomy was more than one year prior to enrollment
  • Age 18 years or older
  • Performance status ECOG 0-2
Not Eligible

You will not qualify if you...

  • Previous bladder or prostate radiotherapy
  • Bladder cancer history with active bladder irrigation protocols or active disease within two years prior to enrollment
  • Previously treated UTUC within one year prior to enrollment
  • Presence of metastatic disease

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Assuta Ashdod Hospital

Ashdod, Israel

Actively Recruiting

2

Soroka University Medical Center

Beersheba, Israel

Actively Recruiting

3

Shamir Medical Center

Be’er Ya‘aqov, Israel

Actively Recruiting

4

Bnai Zion Medical Center

Haifa, Israel, 31048

Actively Recruiting

5

Carmel Medical Center

Haifa, Israel, 34362

Actively Recruiting

6

Rambam Health Care Campus

Haifa, Israel

Actively Recruiting

7

Rabin Medical Center - Beilinson and Hasharon

Petah Tikva, Israel, 4937211

Actively Recruiting

8

Kaplan Medical Center

Rehovot, Israel

Actively Recruiting

9

Ziv Medical Center

Safed, Israel

Actively Recruiting

10

Tel Aviv Sourasky Medical Center - Ichilov

Tel Aviv, Israel

Actively Recruiting

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Research Team

Y

Yuval Freifeld, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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