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Comparing neoadjuvant and adjuvant chemotherapy for upper tract urothelial carcinoma

Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma: A Feasibility Phase II Randomized Clinical Trial ("URANUS")"

Phase 2 Interventional The European Uro-Oncology Group · NCT02969083

This study is testing whether giving chemotherapy before or after surgery helps people with upper tract urothelial carcinoma do better, using real-world data from different European countries.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorThe European Uro-Oncology Group Academic / other
Drugs / interventionschemotherapy, methotrexate
Locations29 sites (Nijmegen, Gelderland and 28 other locations)
Trial IDNCT02969083 on ClinicalTrials.gov

What this trial studies

This study aims to assess the feasibility of neoadjuvant versus adjuvant chemotherapy for patients with upper tract urothelial carcinoma (UTUC) using real-world data from various European countries. Patients with favorable prognostic factors will be randomized to receive either neoadjuvant chemotherapy or adjuvant chemotherapy, while those who do not meet the criteria will undergo radical nephroureterectomy. The study will follow patients for five years to evaluate clinical outcomes and the proportion of patients receiving chemotherapy based on their renal function and performance status.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with histologically confirmed upper tract urothelial carcinoma and adequate organ function.

Not a fit: Patients with bladder cancer or those who do not meet the inclusion criteria for treatment randomization may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimal chemotherapy strategies for patients with upper tract urothelial carcinoma, potentially improving treatment outcomes.

How similar studies have performed: While there is limited data from randomized studies on this topic, the approach of comparing neoadjuvant and adjuvant chemotherapy has shown promise in other cancer types.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract Patients with UTUC cT2-pT4 cN0-N1 M0 (TNM classification)
* Women with negative serum pregnancy test within 14 days of first dose of study treatment and agreement to use effective contraception
* Patients without bladder cancer or with concomitant non muscle invasive bladder cancer
* Adequate organ system function defined as follows: Hematologic: Absolute neutrophil count (ANC) 1.5 X 109/L; Haemoglobin 5.6 mmol/L (9.02g/dL); Platelets 100 X 109/L; Prothrombin time (PT) or international normalized ratio (INR)b 1.2 X ULN; Activated partial thromboplastin time (aPTT)1.2 X Upper limit of normal (ULN). Hepatic: Total bilirubin 1.5 X ULN; Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) 2.5 X ULN. Renal: GRF \<or\> 55 ml/min: Electrolytes: potassium and calcium: within normal limits.
* CT scan of the chest, abdomen and pelvis and Bone scan without evidence of distant metastasis

Exclusion Criteria:

* Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or predominant small cell carcinoma.
* History of cardiovascular conditions within the past 6 months.
* Incidentally found asymptomatic pulmonary embolism (PE) or recent deep vein thrombosis (DVT) is not an exclusion criteria but requires anticoagulation treatment.
* Any major contraindication to a surgical procedure.
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
* Active infection contraindicating chemotherapy
* Other active neoplasms. Patients with in situ cervical carcinoma, non-melanoma skin cancer or prostate cancer T1 Gleason \<7, Prostate specific antigen (PSA) \<10. Patients with past medical history of cancer can be included if diagnosed at least 4 years ago.
* Concomitant muscle invasive bladder cancer
* Patients who have been or still are on methotrexate treatment.

Where this trial is running

Nijmegen, Gelderland and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Upper Tract Urothelial CarcinomaUTUCNeoadjuvant chemotherapyAdjuvant chemotherapyRadical nephroureterectomy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.