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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Israel
Assuta Ashdod Hospital
RECRUITING
Ashdod
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Soroka University Medical Center
RECRUITING
Beersheba
Bnai Zion Medical Center
RECRUITING
Haifa
Carmel Medical Center
RECRUITING
Haifa
Rambam Health Care Campus
RECRUITING
Haifa
Rabin Medical Center - Beilinson and Hasharon
RECRUITING
Petah Tikva
Kaplan Medical Center
RECRUITING
Rehovot
Ziv Medical Center
RECRUITING
Safed
Tel Aviv Sourasky Medical Center - Ichilov
RECRUITING
Tel Aviv
Contact Information
Primary
Yuval Freifeld, Dr
yuvalfr@clalit.org.il
+972-4-8250843
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 264
Treatments
Experimental: A
Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation
Placebo_comparator: B
Single post-operative 50cc Saline 0.9% bladder instillation
Sponsors
Leads: Carmel Medical Center

This content was sourced from clinicaltrials.gov

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