The aim of this study is to explore feasibility of Upper Tract Urothelial Carcinoma (UTUC) treatments based in real world data in various European countries. The study will allow to gain insight in the true proportion of patients that fit to receive complete cisplatin-based neo-adjuvant or adjuvant chemotherapy, and the proportion and clinical outcome of patients with poor prognostic factors (PS and renal function) who receive only standard treatment (Radical nephroureterectomy (RNU)). This comparison will be made using a uniform diagnostic and treatment protocol.

Brief Title

Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma

Official Title

Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma: A Feasibility Phase II Randomized Clinical Trial ("URANUS")"

Brief Summary

The aim of this study is to explore feasibility of Upper Tract Urothelial Carcinoma (UTUC) <br /> treatments based in real world data in various European countries. The study will allow to <br /> gain insight in the true proportion of patients that fit to receive complete cisplatin-based <br /> neo-adjuvant or adjuvant chemotherapy, and the proportion and clinical outcome of patients <br /> with poor prognostic factors (PS and renal function) who receive only standard treatment <br /> (Radical nephroureterectomy (RNU)). This comparison will be made using a uniform diagnostic <br /> and treatment protocol.

Detailed Description

There are no definitive treatment recommendations for patients diagnosed with UTUC. Radical
nephroureterectomy (RNU) has been considered the gold standard treatment for UTUC. However
due to the high recurrence rates reported, patients are often offered perioperative
chemotherapy provided that they have a good renal function and performance status. With
regard to the choice of chemotherapy treatment, there are also no clear recommendations since
there are no data from randomized studies. If perioperative chemotherapy is considered in
daily practice, gemcitabine/cisplatin regimen is often chosen and occasionally dd-MVAC.

The aim of this study is to explore feasibility of UTUC treatments based in real world data
in various European countries. Patients who fulfil good prognostic factors (inclusion
criteria for treatment randomization) will be allocated to neo-adjuvant (Arm B) or adjuvant
(Arm C) chemotherapy (receiving 3 cycles of gemcitabine/cisplatin or dose dense Methotrexate,
Vinblastine, Adriamycin, and Cisplatin (MVAC). Patients who don't fulfil criteria for
treatment randomization will undergo Radical nephroureterectomy (RNU) only (Arm A). Patients
will be followed up for 5 years.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.