Tests chemotherapy timing around surgery for upper urinary tract cancer
Tests chemotherapy before or after surgery in adults with upper urinary tract cancer.
Plain-language title generated from the registry record
Registry title: Feasibility study of Neo-adjuvant (before surgery) versus Adjuvant (after surgery) chemotherapy in Upper Tract Urothelial Carcinoma
Key facts
- Where
- Bergen, NorwaySee the site
- Phase
- Phase 2
Where in Norway
- University In BergenBergen, NorwayNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.