POST URS Chemotherapy Instillation

Recruiting now · Not applicable

Conditions studied: UTUC

In brief

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.

Key facts

Study ID

NCT06167057

Run by

Carmel Medical Center

People needed

264

Starts

2023-04-17

Expected to finish

2028-01-30

Last updated by the study team

2023-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Assuta Ashdod Hospital — Ashdod, Israel (enrolling)
• Soroka University Medical Center — Beersheba, Israel (enrolling)
• Shamir Medical Center — Be’er Ya‘aqov, Israel (enrolling)
• Bnai Zion Medical Center — Haifa, Israel (enrolling)
• Carmel Medical Center — Haifa, Israel (enrolling)
• Rambam Health Care Campus — Haifa, Israel (enrolling)
• Rabin Medical Center - Beilinson and Hasharon — Petah Tikva, Israel (enrolling)
• Kaplan Medical Center — Rehovot, Israel (enrolling)
• Ziv Medical Center — Safed, Israel (enrolling)
• Tel Aviv Sourasky Medical Center - Ichilov — Tel Aviv, Israel (enrolling)

Full record on ClinicalTrials.gov

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