The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    78
  • sponsor
    National Cancer Center, Korea
Updated on 23 January 2021
cancer
mitomycin
bladder cancer
invasive bladder cancer
transurethral resection
bladder tumor

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

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.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment neoadjuvant intravesical mitomycin-C 40mg/20ml instillation, intravesical mitomycin-C 40mg/20ml instillation
Clinical Study IdentifierNCT03058757
SponsorNational Cancer Center, Korea
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 84 yrs?
Gender: Male or Female
Do you have any of these conditions: Bladder Carcinoma or bladder disorder or urinary tract neoplasm or bladder cancer or Urothelial Cancer or Urologic Cancer or Bladder Disorders?
Do you have any of these conditions: urinary tract neoplasm or Bladder Carcinoma or Urologic Cancer or carcinoma of the bladder or Urothelial Cancer or Bladder Disorders or bladder disord...?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note