“Neo-adjUvant veRsus AdjuvaNt chemotherapy in Upper Tract Urothelial Carcinoma: A feaSibility phase II randomized clinical trial (“URANUS”)” (NCT02969083)

URANUS Study is Cohort Prospective Exploratory phase II randomized clinical trial.
Target disease: Upper urinary tract transitional cell carcinoma (UTUC).
Target group of patients are patients who will be PS0-1, aged ≥ 18, cytological or histological proven upper tract TCC staged cT2-pT4 and cN0-N1 MO. They must have no evidence of distant metastases

The aim of this study is to explore feasibility of UTUC treatments based in real world data in various European countries.

Since there is a lack of solid real world data concerning the proportion of patients with UTUC undergoing surgery alone or perioperative chemotherapy and concerning the outcome of the three treatment approaches considered in the various hospitals across Europe, we aim to systematically collect data of patients with this disease.

Patients with a diagnosis of invasive UTUC who are scheduled to undergo a radical nephro-ureterectomy (RNU) or distal ureterectomy and resection of all macroscopically abnormal nodes and clinically staged as cT2-pT4, cN0-N1 M0, will be included in the study. From this initial number of patients, a renal function evaluation will be performed.

Those who fulfil randomization treatment criteria (GFR ≥55ml/min) will be randomized to adjuvant chemotherapy (after RNU)(GROUP C) or neo-adjuvant chemotherapy (before RNU)(GROUP B).
Patients allocated to neo-adjuvant or adjuvant chemotherapy will receive 3 cycles of gemcitabine/cisplatin or 3 cycles of dose dense methotrexate, vinblastine, doxorubicin, and cisplatin combination therapy. Patients with poor renal function (GFR<55ml/min) will not receive chemotherapy treatment (GROUP A)Participants in the three groups will be followed up according to recommended routine practice. The study drugs are prescribed in routine clinical practice (clinical guidelines recommendation) in these patients. This study does not attempt to change chemotherapy prescribing habits.