Clinical trial NCT03062059: The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence
Official title: The Effectiveness and Safety of Intravesical Gemcitabine Instillation During Operation to Prevent Intravesical Recurrence After Radical Nephroureterectomy in Upper Urinary Tract Urothelial Carcinoma: Prospective, Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urothelial Carcinoma
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Samsung Medical Center
name: Asan Medical Center
name: Seoul National University Hospital
name: Korea University Anam Hospital
name: Chong Kun Dang Pharmaceutical Corp.
First posted: 2017-02-23
Enrollment: 134
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Two years
Secondary outcomes:
measure: 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.
timeFrame: six years
measure: Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group.
timeFrame: six years
measure: CT cystography finding at one week after surgery.
timeFrame: one week
measure: International Prostate Symptom Score questionnaire at one week after surgery.
timeFrame: one week
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Korea universitiy
name: Seok Ho Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: