The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
NCT ID: NCT03058757
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
71 participants
INTERVENTIONAL
2017-02-01
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control arm
No intervention applied.
No interventions assigned to this group
Intervention arm
neoadjuvant intravesical mitomycin-C 40mg/20ml instillation
intravesical mitomycin-C 40mg/20ml instillation
neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation
* one day before surgery
* four hours before surgery
Interventions
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intravesical mitomycin-C 40mg/20ml instillation
neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation
* one day before surgery
* four hours before surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
84 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Ho Kyung Seo
Primary Investigator
Principal Investigators
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Ho Kyung Seo, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center
Locations
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National Cancer Center
Goyang, , South Korea
Countries
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Other Identifiers
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NeoadjMitomycin-C
Identifier Type: -
Identifier Source: org_study_id
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