Clinical trial · Interventional
POST URS Chemotherapy Instillation
Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| UTUC | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitomycin/Gemcitabine | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation
- interventionNames
- Drug: Mitomycin/Gemcitabine
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Single post-operative 50cc Saline 0.9% bladder instillation
- interventionNames
- Drug: Saline
Primary outcomes (1)
- measure
- 1 year IVR free survival
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available