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
- Diseases
- Bladder cancer
- 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
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Not yet recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Fundació Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Not yet recruiting |
| Hospital General Universitario Santa Lucia Coordinator of this site? Confirm its status | Cartagena | Spain | Not yet recruiting |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Not yet recruiting |
| Hospital Universitari de Girona Doctor Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Not yet recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Not yet recruiting |
| Hospital de Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Not yet recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Not yet recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin Coordinator of this site? Confirm its status | Las Palmas De Gran Canaria | Spain | Not yet recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Hospital General Universitario Morales Meseguer Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Not yet recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Not yet recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Not yet recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Not yet recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Not yet recruiting |
| Universidade De Santiago De Compostela Coordinator of this site? Confirm its status | Santiago De Compostela | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
| Academisch Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Radboud Universitair Medisch Centrum (Radboudumc) Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| University In Bergen Coordinator of this site? Confirm its status | Bergen | Norway | Not yet recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.