Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-24 @ 2:25 PM
NCT ID:
NCT03062059
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
84 Years
Study:
NCT03062059
Study Brief:
Protocol Section:
NCT03062059