Bladder Cancer
Conditions
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.
Interventions
DRUGintravesical mitomycin-C 40mg/20ml instillation
neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation * one day before surgery * four hours before surgery
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed