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

There are no definitive treatment recommendations for patients diagnosed with
UTUC and therefore there is variable clinical practice amongst centres and
countries.
Radical nephroureterectomy (RNU) is considered the gold standard treatment and
patients with good renal function are often offered perioperative chemotherapy
URANUS explores feasibility and collection of real world data of UTUC treatment
in European and other countries (i.e. Japan).

This study has been transitioned to CTIS with ID 2024-514991-41-01 check the CTIS register for the current data.

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

URANUS Study is Cohort Prospective Exploratory phase II randomized clinical
trial.
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-cT4, 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) and are able
to receive chemotherapy 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) or with good renal function but unfit for
cisplatin-based chemotherapy 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.

Surgery is standard patient care
Chemotherapy in patients with bladder and upper tract rinary carcinoma is often
also considered standard of patient care.
Thus, no true intervention within the context of the study, while the study
mainly aims to collect real world data

There is no extra burden or risk for patients in URANUS trial. The study is
based on standard of care of UTUC patients.