Clinical trial · Interventional
Value of Immediate Post-operative Intravesical Epirubicin in Intermediate&High Risk Non Muscle Invasive Bladder Cancer
The Value of Immediate Post-operative Intravesical Epirubicin Instillation in Intermediate and High Risk Non Muscle Invasive Bladder Cancer (NMIBC): A Randomized Controlled Trial
NCT02214602CI-TRIAL-00032195NMIBCIVTcompletedPhase 4ClinicalTrials.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)
The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).
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 |
|---|---|---|---|
| Carcinoma of Urinary Bladder, Superficial | Bladder Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin | Drug | Epirubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study group(Epirubicin)
- description
- in this arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor
- interventionNames
- Drug: Epirubicin
- type
- NO_INTERVENTION
- label
- Control group
- description
- in this arm -control group- : patients will not receive immediate intravesical instillation of of epirubicin after compete transurethral resection of bladder tumor.
Primary outcomes (1)
- measure
- Recurrence, progression and/or death from cancer.
- timeFrame
- within the 1st year after complete Transurethral resection of bladder tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to give informed consent. * Patients with primary or recurrent papillary Non muscle invasive bladder cancer (NMIBC). * Complete transurethral resection of bladder tumor(TURBT). * Normal cardiac, hematological, and renal functions. * Patients with intermediate and high risk NMIBC confirmed by histopathology. Exclusion Criteria: * Inability to give informed consent. * Patients with history of previous radiotherapy or systemic chemotherapy. * Patients suffering from immuno-deficiency or other malignancies. * Patients with history of hypersensitivity reaction to epirubicin. * Examination under anesthesia (EUA) reveals palpable bladder mass. * Patients with primary, single, less than 1cm papillary bladder tumor (high likelihood of being low risk). * Suspicion of perforation of the bladder during TURBT. * Patients who develop hematuria in the recovery room necessitating continuous bladder wash or endoscopic haemostasis. * Patients with proven low risk NMIBC on histopathology.
References
Publications (1)
- DERIVEDElsawy AA, El-Assmy AM, Bazeed MA, Ali-El-Dein B. The value of immediate postoperative intravesical epirubicin instillation as an adjunct to standard adjuvant treatment in intermediate and high-risk non-muscle-invasive bladder cancer: A preliminary results of randomized controlled trial. Urol Oncol. 2019 Mar;37(3):179.e9-179.e18. doi: 10.1016/j.urolonc.2018.10.019. Epub 2018 Nov 14. PMID 30448030