Single chemotherapy instillation after ureteroscopy for UTUC
Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carmel Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Ashdod and 9 other locations) |
| Trial ID | NCT06167057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with radiographic or cytological suspicion for UTUC who are scheduled for an endoscopic procedure.
Not a fit: Patients with active bladder cancer, recent bladder or prostate radiotherapy, or those with metastatic disease may not benefit from this study.
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 performed: Retrospective evidence suggests that similar approaches have been effective in reducing IVR rates, indicating potential for success in this study.
Eligibility criteria
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 this trial is running
Ashdod and 9 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.