The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence
NCT ID: NCT03062059
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
134 participants
INTERVENTIONAL
2018-03-01
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Normal saline
Intravesical 52.6ml normal saline instillation during radical nephroureterectomy followed by normal saline bladder irrigation
Normal saline
Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma
Gemcitabine
Intravesical 2000mg/52.6ml gemcitabine instillation during radical nephroureterectomy followed by normal saline bladder irrigation
Intravesical 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
Interventions
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Intravesical 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
Normal saline
Intravesical 52.6ml normal saline instillation after radical nephroureterectomy in upper urinary tract urothelial carcinoma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
84 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Asan Medical Center
OTHER
Seoul National University Hospital
OTHER
Korea University Anam Hospital
OTHER
Chong Kun Dang Pharmaceutical Corp.
INDUSTRY
National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Ho Kyung Seo
Primary Investigator
Principal Investigators
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Seok Ho Kang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Korea universitiy
Locations
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National Cancer Center
Goyang, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Ho Kyung Seo, M.D.
Role: primary
Bum Sik Hong, M.D.
Role: primary
Seok Ho Kang, M.D.
Role: primary
Byong Chang Jeong, M.D.
Role: primary
Ja Hyun Ku, M.D.
Role: primary
Other Identifiers
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InstiGem
Identifier Type: -
Identifier Source: org_study_id
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