Clinical trial · Interventional
Prophylactic Intravesical Chemotherapy After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: a Randomized Controlled Trial Between Single Postoperative Dose Versus Maintenance Therapy.
NCT02438865CI-TRIAL-00034846completedPhase 2ClinicalTrials.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)
This clinical trial is designed to compare the effect of single postoperative intravesical chemotherapy instillation versus maintenance therapy on reducing bladder cancer recurrence after surgery for UTUC.
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 |
|---|---|---|---|
| Neoplasm, Bladder | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm, Ureter | Ureter Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immediate instillation of intravesical chemotherapy-Epirubicin- | Drug | — | UNRESOLVED |
| Maintainance therapy of intravesical chemotherapy-Epirubicin- | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Single instillation group
- description
- will receive single intravesical dose of epirubicin intravesical therapy (50 mg) within 48 hours of radical nephroureterectomy with open bladder cuff excision.
- interventionNames
- Drug: Immediate instillation of intravesical chemotherapy-Epirubicin-
- type
- ACTIVE_COMPARATOR
- label
- Maintainance therapy group
- description
- will receive a single intravesical dose of epirubicin and an additional 6 weekly doses of intravesical therapy (50 mg) after surgery then monthly maintenance therapy for 1 year.
- interventionNames
- Drug: Maintainance therapy of intravesical chemotherapy-Epirubicin-
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with UTUC without history of bladder tumor 2. Patients with UTUC without synchronous bladder tumor Exclusion Criteria: 1. Patients with history of bladder tumor 2. Patients with synchronous bladder tumor 3. Patients with advanced stage (T4)
References
Publications (0)
Data not yet available
No reference posted for this study.