Neoadjuvant Chemotherapy Before Surgery vs Surgery Alone for UTUC: A Randomized Trial

Naval Military Medical University

Status and phase: Active, not recruiting; Phase 2

Conditions: Upper Urinary Tract Urothelial Carcinoma; Urothelial Carcinoma Ureter; Neoadjuvant Therapy

Treatments: Drug: Neoadjuvant Gemcitabine + Cisplatin Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07492225

CH-UTUC NAC vs NNAC

Details and patient eligibility

About

This clinical trial aims to compare the effectiveness and safety of two treatment options for patients with high-risk upper tract urothelial carcinoma (UTUC). One group will receive neoadjuvant chemotherapy with gemcitabine and cisplatin followed by surgery (radical nephroureterectomy), while the other group will undergo surgery without chemotherapy. The primary goal is to assess the pathological response to treatment, focusing on how much the tumor shrinks before surgery. The trial will also evaluate the safety of the treatments, overall survival, and recurrence-free survival. This study will help determine whether adding chemotherapy before surgery improves outcomes for patients with high-risk UTUC.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed high-risk upper tract urothelial carcinoma (UTUC).
2. Clinically non-metastatic UTUC (N≤1, M0) based on imaging (CT/MRI).
3. Planned for radical nephroureterectomy (RNU).
4. ECOG performance status of 0 or 1.
5. Sufficient renal function (GFR ≥45 mL/min) and able to tolerate chemotherapy with cisplatin.
6. Age ≥18 years.
7. Informed consent signed.

Exclusion criteria

1. Imaging shows ≥N2 disease or metastatic disease (M1).
2. History of invasive or lymph node-positive UTUC or invasive disease in the contralateral upper tract in the last 2 years.
3. Single kidney or contraindication to cisplatin.
4. Currently participating in other interventional clinical trials.
5. History of non-urothelial malignancies (except treated skin basal cell carcinoma or cervical carcinoma in situ).
6. Pregnant or breastfeeding women.
7. Any other medical condition deemed inappropriate by the treating physician.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

NAC+RNU

Experimental group

Treatment:

Drug: Neoadjuvant Gemcitabine + Cisplatin Chemotherapy

RNU

No Intervention group