Status:
ACTIVE_NOT_RECRUITING
A Comparative Study of Neoadjuvant Chemotherapy Versus Upfront Radical Surgery for Upper Tract Urothelial Carcinoma
Lead Sponsor:
Changhai Hospital
Conditions:
UTUC
UC (Urothelial Cancer)
Eligibility:
All Genders
18+ years
Brief Summary
This is a single-center, open-label, non-randomized controlled trial comparing the efficacy and safety of neoadjuvant chemotherapy (NAC) followed by radical surgery versus upfront radical surgery alon...
Eligibility Criteria
Inclusion
- Histologically confirmed upper tract urothelial carcinoma (UTUC). For mixed histology, urothelial carcinoma must be the predominant component (≥50%).
- Clinically non-metastatic disease (cN≤1, M0) as determined by cross-sectional imaging (CT or MRI of chest/abdomen/pelvis).
- Planned treatment with radical nephroureterectomy (RNU).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate renal function, defined as glomerular filtration rate (GFR) ≥ 45 mL/min, making the patient a potential candidate for cisplatin-based neoadjuvant chemotherapy.
- Adequate organ and bone marrow function as determined by standard screening tests.
- Recovery from all reversible toxicities of any prior surgery.
- Age ≥ 18 years at the time of enrollment.
- Ability to understand the study and provide signed informed consent.
Exclusion
- Radiographic evidence of ≥cN2 lymph node disease or distant metastases (M1).
- History of invasive, lymph node-positive, or metastatic urothelial carcinoma within 2 years prior to enrollment, or history of invasive contralateral UTUC.
- Presence of only a solitary kidney or cisplatin ineligibility.
- Concurrent participation in another interventional clinical trial at the time of enrollment.
- History of a non-urothelial malignant tumor unless the patient has been disease-free for at least 1 year (exceptions include adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix).
- Pregnancy or lactation. Women and men of reproductive potential must agree to use effective contraception.
- Any other medical condition, comorbidity, or psychiatric illness that, in the investigator's judgment, would make the patient an unsuitable candidate for the study.
Key Trial Info
Start Date :
May 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 15 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07155044
Start Date
May 15 2024
End Date
May 15 2029
Last Update
September 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200090