The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: intravesical mitomycin-C 40mg/20ml instillation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>No intervention applied. | |
| Experimental: Intervention arm<br>neoadjuvant intravesical mitomycin-C 40mg/20ml instillation | Drug: intravesical mitomycin-C 40mg/20ml instillation<br>* neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation one day before surgery four hours before surgery<br>* Other names: Mitomycin_C Kyowa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |