None listed
Conditions
Interventions
Drug : Participants will be randomly assigned to either the NAC group or the upfront surgery group. NAC Group will receive the neoadjuvant cisplatin/gemcitabine chemotherapy 3 cycle before Radical Nep
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed Consent: Individuals who have understood the purpose and procedures of the study and have provided written informed consent. 2.Age: Adults aged 19 years or older. 3.Histological Diagnosis: Patients histologically confirmed to have high-grade, non-metastatic upper tract urothelial carcinoma (renal pelvis and/or ureter). 4.Clinical Stage: Clinical staging based on imaging indicates cT2–cT4/cN0–N1/M0 (according to TNM classification), and urine cytology is positive, if performed. 5.Absence of Metastatic Disease: No evidence of distant metastasis. 6.ECOG Performance Status: ECOG performance status score of 0 to 1. 7.Presence of Bladder Cancer: Either no bladder cancer or concomitant non–muscle-invasive bladder cancer is allowed. 8.Adequate Bone Marrow Function (all of the following must be met): Absolute neutrophil count (ANC) = 1,500/µL Platelet count (PLT) = 100,000/µL Hemoglobin (Hb) = 9.0 g/dL (intermittent transfusions allowed) 9.Adequate Liver Function: Total bilirubin = 1.5 × ULN AST and ALT = 3 × ULN 10.Adequate Renal Function: Serum creatinine = 1.5 × ULN or Creatinine clearance rate = 50 mL/min (using Cockcroft-Gault or MDRD formula) 11.Cooperation: Individuals able and willing to comply with study procedures and follow-up through the end of the study. 12.For Women of Childbearing Potential: Negative serum or urine ß-hCG test within 28 days prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1.Ongoing treatment with other anticancer agents not specified in this protocol. 2.Metastatic disease: Presence of metastatic lesions other than lymph node metastasis confirmed by imaging studies. 3.Cardiovascular disease: History of clinically relevant coronary artery disease or myocardial infarction within the past 3 years; congestive heart failure of NYHA class III or higher; cerebrovascular accident; serious medical or physiological conditions interfering with study participation; serious cardiac arrhythmias requiring medication except for atrial fibrillation within the past year or currently. 4.Neurological abnormalities: Evidence of grade 2 or higher neuropathy intolerable within 4 weeks prior to Day 1 of Cycle 1, or unstable neurological symptoms. 5.Major surgery history: Major surgery (excluding diagnostic surgery or transurethral resection) within 4 weeks prior to Day 1 of Cycle 1 without complete recovery. 6.History of other malignancies: History of double primary malignancies or other malignant tumors at different sites (except for cured cases). 7.Infection: Active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment. 8.Drug hypersensitivity: History of hypersensitivity to study drugs or other platinum-containing agents. 9.Pregnancy and breastfeeding: Pregnant or breastfeeding women. 10.Lack of contraception compliance: Male or female patients of reproductive potential unwilling to use highly effective contraception methods (such as abstinence, hormonal contraception, intrauterine device [IUD/IUS], or permanent sterilization [vasectomy/tubal ligation]) during the minimum required period (females: during treatment and for 14 months after last dose; males: during treatment and for 11 months after last dose). 11.Contraindications to study drug administration per protocol: severe renal impairment, severe hepatic impairment, severe bone marrow suppression, hearing impairment, neuropathy caused by study drugs, interstitial pneumonitis or pulmonary fibrosis, patients undergoing thoracic radiation therapy. 12.Other medical issues: Any significant medical or psychiatric condition deemed by the investigator to be inappropriate for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Recurrence-Free Survival Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response Rate (pathologic CR rate);Pathologic Response Rate (< ypT2N0);Overall Survival (OS);Cancer-Specific Survival (CSS);Progression-Free Survival (PFS);Adverse Events;Quality of Life | — |
Countries
Korea, Republic of
Contacts
Public ContactJunyeong Kim
Samsung Medical Center
Outcome results
None listed