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NCT Number: NCT07492225

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neoadjuvant Therapy Upper Urinary Tract Urothelial Carcinoma Urothelial Carcinoma Ureter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200090, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Neoadjuvant Gemcitabine + Cisplatin Chemotherapy

Drug

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.

Primary outcomes

  1. Pathological Response Rate

    Time frame: 6 weeks after surgery

    Proportion of patients with ypT1N0 or lower after surgery in the neoadjuvant chemotherapy + partial nephrectomy group compared to the direct partial nephrectomy group.

Secondary outcomes

  1. Chemotherapy Safety and Tolerability

    Time frame: During chemotherapy and post-surgery follow-up

    Incidence, severity, and clinical management of treatment-related adverse events (TRAEs) according to CTCAE v5.0.

  2. Overall Survival (OS)

    Time frame: 24 months after surgery

    Time from surgery to death from any cause.

  3. Cancer-Specific Survival (CSS)

    Time frame: 24 months after surgery

    Time from surgery to death due to UTUC.

  4. Recurrence-Free Survival (RFS)

    Time frame: 24 months after surgery

    Time from surgery to first recurrence of UTUC.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Comparative Efficacy of Neoadjuvant Chemotherapy Versus Immediate Nephroureterectomy in the Treatment of Localized Upper Tract Urothelial Carcinoma: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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