Clinical trial · Interventional
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer
NCT05084586CI-TRIAL-00065067unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Epirubicin Adverse Reaction | — | UNRESOLVED | — |
| Superficial Bladder Cancer | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
| Tumor Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravesical Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Continuous Intravesical Infusion of Epirubicin
- description
- Patients who received continuous epirubicin infusion into the bladder in the early postoperative period.
- interventionNames
- Drug: Intravesical Solution
- type
- SHAM_COMPARATOR
- label
- Single-Dose Instillation of Epirubicin
- description
- Patients who received single-dose epirubicin into the bladder in the early postoperative period.
- interventionNames
- Drug: Intravesical Solution
Primary outcomes (1)
- measure
- Rate of Tumor Recurrence and Progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Low and intermediate risk NMIBC Exclusion Criteria: * High risk NMIBC * Patients who received intravesical BCG * Postoperative gross hematuria * Bladder perforation * Pregnancy * Urinary tract infection * Epirubicin allergy
References
Publications (3)
- BACKGROUNDEngeler DS, Wyler S, Neyer M, Hobi C, Muller J, Schmid HP. Feasibility of early intravesical instillation chemotherapy after transurethral resection of the bladder: a prospective evaluation in a consecutive series of 210 cases. Scand J Urol Nephrol. 2008;42(6):522-7. doi: 10.1080/00365590802133099. PMID 18609290
- BACKGROUNDMaekawa S, Suzuki H, Ohkubo K, Aoki Y, Okada T, Maeda H, Ogura K, Arai Y. [Continuous intravesical instillation of epirubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study]. Hinyokika Kiyo. 2000 May;46(5):301-6. Japanese. PMID 10876750
- BACKGROUNDWu ZB, Lin GB, Chen BJ, Wu ZM, Rong RM. [Efficacy and safety of different dosages of intravesical epirubicin instillation for prevention of primary superficial bladder carcinoma from recurrence]. Zhonghua Zhong Liu Za Zhi. 2005 Aug;27(8):507-9. Chinese. PMID 16188156