Clinical trial · Interventional
Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy
- 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 objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Cancer of Renal Pelvis | — | UNRESOLVED | — |
| Urothelial Carcinoma Ureter | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intravesical mitomycin C (MMC)
- interventionNames
- Drug: Mitomycin C
- type
- NO_INTERVENTION
- label
- No intervention
Primary outcomes (3)
- measure
- Recruitment rate
- timeFrame
- 30 days
- description
- Proportion of patients who consent to participate in the study after being invited to do so
- measure
- Randomization rate
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected upper tract urothelial carcinoma (UTUC) * Diagnostic ureteroscopy required * Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy Exclusion Criteria: * Prior or concomitant urothelial carcinoma of the bladder * History of UTUC * Ureteroscopy within the preceding six months * Untreated urinary tract infection * Suspected or confirmed perforation of the upper or lower urinary tract * Lower urinary tract fistula * Leukopenia or thrombocytopenia * ECOG performance status 2 or greater * Known hypersensitivity to mitomycin C * Pregnancy or breastfeeding * Lack of capacity to consent
References
Publications (0)
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