The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

National Cancer Center (NCC)

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer

Treatments: Drug: intravesical mitomycin-C 40mg/20ml instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT03058757

NeoadjMitomycin-C

Details and patient eligibility

About

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

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 20 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Control arm

No Intervention group

Description:

No intervention applied.

Intervention arm

Experimental group

Description:

neoadjuvant intravesical mitomycin-C 40mg/20ml instillation

Treatment:

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