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

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.

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