MedTrace Logo

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

NCT07492225 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-25

No results posted yet for this study

Summary

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.

Conditions

  • Neoadjuvant Therapy
  • Urothelial Carcinoma Ureter
  • Upper Urinary Tract Urothelial Carcinoma

Interventions

DRUG

Neoadjuvant Gemcitabine + Cisplatin Chemotherapy

Patients in the experimental group will receive neoadjuvant chemotherapy with a combination of gemcitabine and cisplatin before undergoing surgery. The chemotherapy regimen consists of: Gemcitabine: 1000 mg/m², administered on Day 1 and Day 8 of each 21-day cycle. Cisplatin: 70 mg/m², administered on Day 2 of each 21-day cycle. This treatment will be repeated for 3 to 4 cycles. The goal of this chemotherapy is to shrink the tumor and improve the chances of a successful surgery. After completing the chemotherapy, patients will undergo radical nephroureterectomy (RNU), a surgery to remove the kidney and ureter affected by cancer, within 6 weeks (+/- 2 weeks) of the last chemotherapy cycle. This approach is designed to evaluate if chemotherapy before surgery can improve pathological response and long-term survival outcomes.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2027-08-15
Completion
2029-08-15

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492225 on ClinicalTrials.gov