The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

National Cancer Center, Korea71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bladder Cancer

Interventions

intravesical mitomycin-C 40mg/20ml instillationDRUG

neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation * one day before surgery * four hours before surgery

Eligibility

Sex: ALLMin age: 20 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center

Goyang, South Korea

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: six years

Data from ClinicalTrials.gov

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