Tests chemotherapy timing around surgery for upper urinary tract cancer

Trial details

Who runs it

European Uro-Oncology Group Stichting

Trial code

NCT02969083EU 2024-514991-41-01

Record updated

5 October 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: •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.

ClinicalTrials.gov NCT02969083 · EU CTIS 2024-514991-41-01