Clinical trial NCT03399643: A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)
Official title: Non-Interventional Study To Investigate The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urothelial Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-01-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients ineligible for palliative cisplatin-based chemotherapy or who received prior adjuvant/ neoadjuvant chemotherapy or chemo radiation with a treatment-free interval more than 12 months (1L)

Brief summary: The objective of this study is to investigate the effectiveness of Atezolizumab with a primary focus on the overall survival (OS) rate at 2 years and secondary focuses on quality of life (QoL) and the sequence of treatment in mUC patients. Furthermore, this study aims at collecting data on safety of Atezolizumab and on the reason for cisplatin-ineligibility


Eligibility criteria: Inclusion Criteria:

* Metastatic UC (Urothelial Carcinoma) including cancers of the renal pelvis, ureters, urinary bladder, and urethra
* Will be receiving atezolizumab for the treatment of inoperable locally-advanced or metastatic UC, per the decision of the treating physician
* Have adequate hematologic and end-organ functions
* Have had no prior palliative chemotherapy for inoperable locally-advanced or metastatic UC and are clinically ineligible ("unfit") for cisplatin-based chemotherapy

Exclusion Criteria:

* Have received prior immune checkpoint therapy
* Are pregnant or breastfeeding
* Are included in any other trial

Primary outcomes:
measure: Overall Survival Rate (OS rate)
timeFrame: 2 years
Secondary outcomes:
measure: Median Overall Survival (OS)
timeFrame: Initiation of study treatment until death or end of study, approximately 4 years
measure: Median Progression Free Survival (PFS)
timeFrame: Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years)
measure: Percentage of participants with adverse events
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Praxis Dr.med. Wolfgang Hölzer
city: Braunschweig
country: Germany
facility: Urologie Schlosscarree
city: Chemnitz
country: Germany
facility: Urologische Praxis Dr. Krieger
city: Chemnitz
country: Germany
facility: Zeisigwaldkliniken Bethanien
city: Eisenach
country: Germany
facility: St. Georg Klinikum Eisenach GmbH
city: Flensburg
country: Germany
facility: St. Franziskus-Hospital; Malteser Krankenhaus; Medizinische Klinik I
city: Frankfurt am Main
country: Germany
facility: Klinikum Frankfurt Höchst GmbH; Klinik Innere Medizin 3 - Hämatologie, Onkologie, Palliativmedizin
city: Fürth
country: Germany
facility: Dres.Jochen Wilke und Harald Wagner
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie
city: Halle
country: Germany
facility: Urologische Praxis Michael Steinacker
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona, Abteilung für Urologie
city: Heidenheim
country: Germany
facility: Onkologische Praxis in Heidenheim
city: Hildesheim
country: Germany
facility: St. Bernward-Krankenhaus
city: Landshut
country: Germany
facility: Onkologische Praxis Landshut
city: Lebach
country: Germany
facility: Gemeinschaftspraxis; Onkologisches Zentrum Lebach; Caritas Krankenhaus Lebach
city: Leipzig
country: Germany
facility: ÜBAG MVZ Mitte / MVZ Delitzsch GmbH, Standort Leipzig
city: Leipzig
country: Germany
facility: Sankt Elisabeth Krankenhaus; Urlogische Abt.
city: Luckenwalde
country: Germany
facility: Drk Krankenhaus Luckenwalde
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie
city: Lübeck
country: Germany
facility: Urologikum Lübeck
city: Lüneburg
country: Germany
facility: Urologischen Praxis in Lüneburg
city: Mannheim
country: Germany
facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie
city: Markkleeberg
country: Germany
facility: Praxis Markkleeberg
city: Minden
country: Germany
facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Hämatologie, Onkologie und Pallia.
city: München
country: Germany
facility: Städt.Kliniken München GmbH Klinikum Bogenhausen
city: Naunhof
country: Germany
facility: Praxis Dr. Uhlig, Naunhof
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie
city: Saarbruecken
country: Germany
facility: Praxis für Hämatologie & Onkologie
city: Stade
country: Germany
facility: MVZ für Hämatologie, Onkologie, Strahlentherapie und Palliativmedizin -; Klinik Dr. Hancken
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
city: Wedel
country: Germany
facility: Urologische Praxis
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede Aurich Rhauder
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: