The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

Bladder Cancer Clinical Trial

Official title:

The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058757
• Other study ID #: NeoadjMitomycin-C
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 31, 2022
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• intravesical mitomycin-C 40mg/20ml instillation
neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation one day before surgery four hours before surgery

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1 years
Secondary	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	1 years
Secondary	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	1 years
Secondary	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	six years