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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | No intervention applied. | |
| Intervention arm | Experimental | neoadjuvant intravesical mitomycin-C 40mg/20ml instillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravesical mitomycin-C 40mg/20ml instillation | Drug | neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pathologic recurrence free survival after transurethral resection | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan. | Pathologic or radiologi progression free survival after transurethral resection | 1 years |
| Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho Kyung Seo, M.D. | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang | South Korea |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Period of from transurethral resection to first pathologic recurrence |
| 1 years |
| Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. Change of tumor size will be assessed by CT scan and cystoscopic exam. | Change of tumor size at the time point of diagnostic cystoscope to transurethral resection | 1 years |
| Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. | Safety will be assessed by International Prostate Symptom Score (IPSS; 0-7, mildly symptomatic; 8-19, moderately symptomatic; 20-35 severely symptomatic) and treatment delay | six years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |