Clinical trial · Interventional
Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial
NCT05146635CI-TRIAL-00055862unknownN/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)
The objective of this prospective, single-center randomized controlled trial is to identify the optimal adjuvant intravesical therapy in patients with intermediate risk (IR) non muscle invasive bladder cancer by comparing two commonly utilized intravesical regimens; intravesical immunotherapy (BCG) and intravesical chemotherapy.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravesical Bcg | Drug | — | UNRESOLVED |
| Intravesical chemotherapy (epirubicin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intravesical immunotherapy (BCG) group
- interventionNames
- Drug: Intravesical Bcg
- type
- ACTIVE_COMPARATOR
- label
- Intravesical chemotherapy (Epirubicin) group
- interventionNames
- Drug: Intravesical chemotherapy (epirubicin)
Primary outcomes (2)
- measure
- Tumor recurrence rate
- timeFrame
- 2 years
- description
- Number of patient who will develop Recurrence rate during follow up
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (aged \>18 years) * Patients with primary or recurrent papillary NMIBC. * Complete TURBT. * Patients with IR 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 BCG or epirubicin. * Examination under anesthesia (EUA) reveals palpable bladder mass. * Patients with low or high risk NMIBC by histopathology
References
Publications (0)
Data not yet available
No reference posted for this study.