Urothelial Carcinoma
Conditions
Brief summary
The aim of this study is to evaluate the effectiveness and safety of intravesical gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma.
Detailed description
Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Outcome Measures: Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Secondary Outcome Measures: Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Safety of intravesical 2000mg/52.6ml gemcitabine instillation.
Interventions
DRUGIntravesical 2000mg/52.6ml gemcitabine instillation
Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma
OTHERNormal saline
Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma
Sponsors
Samsung Medical Center
Asan Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Chong Kun Dang Pharmaceutical Corp.
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* The subjects who will undergo nephroureterectomy due to ureter or renal pelvis urothelial carcinoma * Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as upper urinary tract urothelial carcinoma * Normal bone marrow function: Hemoglobin \>10 g/dL, ANC \>1,500/mm3, platelet count\>100,000/mm3 * Normal bladder volume and function * 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
* Concomitant bladder cancer * Subjects who underwent any treatment due to bladder cancer within 3 years * Prior hypersensitivity reaction history to gemcitabine * Neurogenic bladder * Subjects who underwent chemotherapy due to any cancer within 6 months * Subjects who underwent neoadjuvant chemotherapy due to ureter or renal pelvis urothelial carcinoma * Hypersensitivity to gemcitabine or component of gemcitabine * In case of co-administration of gemcitabine and cisplatin in severe renal failure patients * Moderate to severe liver dysfunction or renal dysfunction (Glomerular filtration rate \< 30 mL/min) * Severe bone marrow suppression * Severe infection * Female who are pregnant or has a possibility of pregnancy * Nursing female * Interstitial pneumonia or pulmonary fibrosis which is evident on chest x-ray and symptomatic * Subjects who are undergoing radiotherapy on chest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam. | Two years | Analysis of recurrence status at 2 years from intravesical instillation of 2000mg/52.6ml gemcitabine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. The recurrence will be assessed by CT scan and cystoscopic exam. | six years | Analysis of time from starting intravesical instillation of 2000mg/52.6ml gemcitabine to recurrence |
| Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. | six years | Analysis of survival status due to any cause at six years from intravesical instillation of 2000mg/52.6ml gemcitabine |
| CT cystography finding at one week after surgery. | one week | Evaluation of leakage at CT cystography at one week from intravesical instillation of 2000mg/52.6ml gemcitabine |
| International Prostate Symptom Score questionnaire at one week after surgery. | one week | Evaluation of survey with International Prostate Symptom Score questionnaire a one week after surgery |
Countries
South Korea
Contacts
Primary ContactHo Kyung Seo, M.D.
Backup ContactYoon Seok Suh, M.D.
Outcome results
None listed