The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

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

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 Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Drug: intravesical mitomycin-C 40mg/20ml instillation

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Goyang, Korea, Republic of
    • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control arm; No intervention applied.
EXPERIMENTAL: Intervention arm; neoadjuvant intravesical mitomycin-C 40mg/20ml instillation	Drug: intravesical mitomycin-C 40mg/20ml instillation; neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation; one day before surgery; four hours before surgery; Other Names: Mitomycin_C Kyowa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Ho Kyung Seo, M.D., National Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): February 18, 2021
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antibiotics, Antineoplastic; Mitomycins; Mitomycin
• Other Study ID Numbers: NeoadjMitomycin-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No