The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intravesical mitomycin-C 40mg/20ml instillation
Sponsored by
About this trial
This is an interventional prevention trial for Bladder Cancer
Eligibility Criteria
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
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm
Intervention arm
Arm Description
No intervention applied.
neoadjuvant intravesical mitomycin-C 40mg/20ml instillation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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 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
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
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
Full Information
NCT ID
NCT03058757
First Posted
February 15, 2017
Last Updated
January 30, 2023
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03058757
Brief Title
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
Official Title
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No intervention applied.
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
neoadjuvant intravesical mitomycin-C 40mg/20ml instillation
Intervention Type
Drug
Intervention Name(s)
intravesical mitomycin-C 40mg/20ml instillation
Other Intervention Name(s)
Mitomycin_C Kyowa
Intervention Description
neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation
one day before surgery
four hours before surgery
Primary Outcome Measure Information:
Title
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.
Description
Pathologic recurrence free survival after transurethral resection
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan.
Description
Pathologic or radiologi progression free survival after transurethral resection
Time Frame
1 years
Title
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.
Description
Period of from transurethral resection to first pathologic recurrence
Time Frame
1 years
Title
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.
Description
Change of tumor size at the time point of diagnostic cystoscope to transurethral resection
Time Frame
1 years
Title
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Kyung Seo, M.D.
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
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