Clinical trial NCT03058757: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2017-02-23
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan.
timeFrame: 1 years
measure: 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.
timeFrame: 1 years
measure: 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.
timeFrame: 1 years
measure: Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
timeFrame: six years
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
Study officials:
affiliation: National Cancer Center
name: Ho Kyung Seo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: