The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
- Conditions
- Bladder Cancer
- Interventions
- Drug: intravesical mitomycin-C 40mg/20ml instillation
- Registration Number
- NCT03058757
- Lead Sponsor
- National Cancer Center, Korea
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm intravesical mitomycin-C 40mg/20ml instillation neoadjuvant intravesical mitomycin-C 40mg/20ml instillation
- Primary Outcome Measures
Name Time Method 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. 1 year Pathologic recurrence free survival after transurethral resection
- Secondary Outcome Measures
Name Time Method Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan. 1 years Pathologic or radiologi progression free survival after transurethral resection
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. 1 years Period of from transurethral resection to first pathologic recurrence
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. 1 years Change of tumor size at the time point of diagnostic cystoscope to transurethral resection
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. six years 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
Trial Locations
- Locations (1)
National Cancer Center
🇰🇷Goyang, Korea, Republic of