Trials / Completed
CompletedNCT03058757
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- National Cancer Center, Korea · Other Government
- Sex
- All
- Age
- 20 Years – 84 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Outcome Measures: Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Secondary Outcome Measures: Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | intravesical mitomycin-C 40mg/20ml instillation | neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation * one day before surgery * four hours before surgery |
Timeline
- Start date
- 2017-02-01
- Primary completion
- 2021-02-18
- Completion
- 2022-12-31
- First posted
- 2017-02-23
- Last updated
- 2023-01-31
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03058757. Inclusion in this directory is not an endorsement.