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The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Recruiting
CT.gov ID
NCT03058757
Collaborator
(none)
78
Enrollment
1
Location
2
Arms
82.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: intravesical mitomycin-C 40mg/20ml instillation
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study
Actual Study Start Date :
Feb 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [1 year]

      Pathologic recurrence free survival after transurethral resection

    Secondary Outcome Measures

    1. Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan. [1 years]

      Pathologic or radiologi progression free survival after transurethral resection

    2. 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. [1 years]

      Period of from transurethral resection to first pathologic recurrence

    3. 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. [1 years]

      Change of tumor size at the time point of diagnostic cystoscope to transurethral resection

    4. Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. [six years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 84 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Center Goyang Korea, Republic of

    Sponsors and Collaborators

    • National Cancer Center, Korea

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ho Kyung Seo, Primary Investigator, National Cancer Center, Korea
    ClinicalTrials.gov Identifier:
    NCT03058757
    Other Study ID Numbers:
    • NeoadjMitomycin-C
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Mitomycins
    Mitomycin

    Study Results

    No Results Posted as of Apr 7, 2022