Single chemotherapy instillation after ureteroscopy for UTUC
Official title: Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
Run by Carmel Medical Center · NCT06167057 · Data updated 2026-11-12
This study is testing if a single dose of chemotherapy given after a ureteroscopy can help prevent bladder cancer from coming back in people with upper tract urothelial carcinoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 264 (estimated) |
| Sponsor | Carmel Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Ashdod and 9 other locations) |
| Status | Recruiting |
| Started | April 17, 2023 |
| Main results expected | January 30, 2028 |
| Study ends | January 30, 2028 |
| Registry record updated | December 20, 2023 |
| Trial ID | NCT06167057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with radiographic or cytological suspicion for UTUC who are scheduled for an endoscopic procedure.
✕Probably not a fit
Patients with active bladder cancer, recent bladder or prostate radiotherapy, or those with metastatic disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and effectiveness of a single chemotherapy bladder instillation following endoscopic treatment for upper tract urothelial carcinoma (UTUC). Participants will receive the chemotherapy within 24 hours after undergoing ureteroscopy, and their outcomes will be monitored through routine follow-up, including cystoscopy. The primary goal is to determine if this intervention can reduce the incidence of intravesical recurrence (IVR) in patients suspected of having UTUC. The study aims to build on existing evidence suggesting that post-operative chemotherapy can lower IVR rates.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of intravesical recurrence in patients treated for UTUC.
How similar studies have gone: Retrospective evidence suggests that similar approaches have been effective in reducing IVR rates, indicating potential for success in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 \>1 year prior to enrollment * Age ≥ 18 years * Performance status ECOG 0-2 Exclusion Criteria: * 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's running
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Assuta Ashdod Hospital
Ashdod, Israel Recruiting -
Soroka University Medical Center
Beersheba, Israel Recruiting -
Shamir Medical Center
Be’er Ya‘aqov, Israel Recruiting -
Bnai Zion Medical Center
Haifa, Israel Recruiting -
Carmel Medical Center
Haifa, Israel Recruiting -
Rambam Health Care Campus
Haifa, Israel Recruiting
Show 4 more locations
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Rabin Medical Center - Beilinson and Hasharon
Petah Tikva, Israel Recruiting -
Kaplan Medical Center
Rehovot, Israel Recruiting -
Ziv Medical Center
Safed, Israel Recruiting -
Tel Aviv Sourasky Medical Center - Ichilov
Tel Aviv, Israel Recruiting
Study contacts
- Study coordinator: Yuval Freifeld, Dr
- Email: yuvalfr@clalit.org.il
- Phone: +972-4-8250843
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Urine test to detect urological cancers in people with blood in urine
This study tests whether a urine fluorescence test can help find urological cancers in adults with hematuria before biopsy.
-
Trastuzumab Rezetecan and Gemcitabine before surgery for HER2-positive UTUC
This study tests whether giving trastuzumab deruxtecan with gemcitabine before and around surgery can improve outcomes for people with HER2-positive upper tract urothelial cancer.
-
Non-invasive urine test to screen for urothelial cancer in adults with blood in urine
A noninvasive urine test is being used to see if it can correctly identify urothelial cancer in adults who have blood in urine and a suspicious imaging finding.
-
Monitoring recurrence of urothelial carcinoma using urinary tests
This study is testing if urine tests can help track the return of urothelial carcinoma in patients with different types of bladder and kidney cancer.
-
Combination treatment for HER2-positive upper tract urothelial carcinoma after surgery
This study is testing a new combination of targeted therapy and immune treatment to see if it helps prevent cancer from coming back in patients with HER2-positive upper tract urothelial carcinoma after surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.