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NCT02969083Not yet recruitingPhase 2

Feasibility study of Neo-adjuvant (before surgery) versus Adjuvant (after surgery) chemotherapy in Upper Tract Urothelial Carcinoma

Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (“URANUS”)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Oct 2026

Brief summary (registry, in English)

To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based chemotherapy treatment. To assess the proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy. To assess the administered versus planned dose of chemotherapy in patients randomized to neo- or adjuvant chemotherapy.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
196 (estimated)
First submitted
15 Aug 2024
Start date
15 May 2018
Lead sponsor
European Uro-Oncology Group Stichting
NCT number
NCT02969083
EU CT number
2024-514991-41-01
EudraCT number
2016-004017-27

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 196
  • 41 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • •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 (under investigator criteria). •Other active neoplasms •Concomitant muscle invasive bladder cancer. •Patients who have received prior cisplatin based treatment.

Who the study is looking for

  • 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-cT4 cN0-N1 M0 (TNM classification) •Patients must agree with Summaries of product characteristics (SmPC) contraceptive requirements •Patients without bladder cancer or with concomitant non muscle invasive bladder cancer •Adequate organ system function defined by Hematological results •CT scan of the chest, abdomen and pelvis and bone scan without evidence of distant metastasis

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainNot yet recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainNot yet recruiting
Hospital del Mar
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BarcelonaSpainNot yet recruiting
Fundació Puigvert
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BarcelonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
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BarcelonaSpainNot yet recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainNot yet recruiting
Hospital Universitario Basurto
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BilbaoSpainNot yet recruiting
Hospital General Universitario Santa Lucia
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CartagenaSpainNot yet recruiting
Hospital General Universitario de Ciudad Real
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Ciudad RealSpainNot yet recruiting
Hospital Universitari de Girona Doctor Josep Trueta
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GironaSpainNot yet recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainNot yet recruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainNot yet recruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainNot yet recruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainNot yet recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
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Las Palmas De Gran CanariaSpainNot yet recruiting
Hospital Universitario La Paz
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MadridSpainNot yet recruiting
Hospital Clínico San Carlos
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MadridSpainNot yet recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainNot yet recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainNot yet recruiting
Hospital Universitario de la Princesa
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MadridSpainNot yet recruiting
Clinica Universidad de Navarra
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MadridSpainNot yet recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainNot yet recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainNot yet recruiting
Hospital General Universitario Morales Meseguer
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MurciaSpainNot yet recruiting
Hospital Son Llatzer
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PalmaSpainNot yet recruiting
Hospital Universitario de Navarra
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PamplonaSpainNot yet recruiting
Parc Tauli Hospital Universitari
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SabadellSpainNot yet recruiting
Hospital Universitario De Salamanca
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SalamancaSpainNot yet recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainNot yet recruiting
Universidade De Santiago De Compostela
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Santiago De CompostelaSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainNot yet recruiting
Hospital General Universitario de Valencia
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ValenciaSpainNot yet recruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainNot yet recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainNot yet recruiting
Academisch Medisch Centrum
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AmsterdamNetherlandsNot yet recruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsNot yet recruiting
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsNot yet recruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsNot yet recruiting
University In Bergen
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BergenNorwayNot yet recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.