NCT03058757

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

February 15, 2017

Last Update Submit

January 30, 2023

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (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.

    Pathologic recurrence free survival after transurethral resection

    1 year

Secondary Outcomes (4)

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

    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.

    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.

    1 years

  • Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.

    six years

Study Arms (2)

Control arm

NO INTERVENTION

No intervention applied.

Intervention arm

EXPERIMENTAL

neoadjuvant intravesical mitomycin-C 40mg/20ml instillation

Drug: intravesical mitomycin-C 40mg/20ml instillation

Interventions

intravesical mitomycin-C 40mg/20ml instillationDRUG

neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation * one day before surgery * four hours before surgery

Also known as: Mitomycin_C Kyowa
Intervention arm

Eligibility Criteria

Age20 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ho Kyung Seo, M.D.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

February 1, 2017

Primary Completion

February 18, 2021

Study Completion

December 31, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)