Clinical trial · Interventional
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study
NCT03058757CI-TRIAL-00063558completedPhase 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)
The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical mitomycin-C instillation in non-muscle invasive bladder cancer patients
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intravesical mitomycin-C 40mg/20ml instillation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm
- description
- No intervention applied.
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- neoadjuvant intravesical mitomycin-C 40mg/20ml instillation
- interventionNames
- Drug: intravesical mitomycin-C 40mg/20ml instillation
Primary outcomes (1)
- measure
- Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam.
- timeFrame
- 1 year
- description
- Pathologic recurrence free survival after transurethral resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 84 Years
Show eligibility criteria text
Inclusion Criteria: * The subjects who will undergo transurethral resection of the tumor after diagnosis of bladder cancer * Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as bladder cancer * Normal bone marrow function: Hemoglobin \>10 g/dL, ANC \>1,500/mm3, platelet count\>100,000/mm3 * Normal renal function: serum creatinine ≤ 1.4 mg/dL * Normal liver function: * Bilirubin ≤ 1.5 times of upper normal limit * AST/ALT ≤ 1.8 times of upper normal limit * Alkaline phosphatase ≤ 1.8 times of upper normal limit * Subjects who voluntarily decided to participate and signed the written informed consent Exclusion Criteria: * Non-urothelial carcinoma * Muscle invasive bladder cancer * Subjects who underwent intravesical mitomycin-C instillation after diagnosis of bladder cancer within 3 years * Prior hypersensitivity reaction history to mitomycin-C * Neurogenic bladder * Subjects who underwent chemotherapy due to any cancer within 6 months
References
Publications (0)
Data not yet available
No reference posted for this study.