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JOURNAL ONKOLOGIE – STUDIE
CASSIOPE

Non-interventional Study of Cabozantinib in Adults With Advanced Renal Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT03419572

Studienbeginn:
April 2018

Letztes Update:
24.02.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Renal Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ipsen

Collaborator:
-

Studienleiter

Ipsen Medical Director
Study Director
Ipsen

Kontakt

Studienlocations
(3 von 108)

Klinikum Augsburg, II Medizinische Klinik, Hamatologie/Onkologie
86156 Augsburg
(Bayern)
GermanyZurückgezogen» Google-Maps
Charité - Universitätsmedizin Berlin
12200 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
Vivantes Klinikum Neukolln
12351 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
MVZ- Polyclinic Eisenach
99817 Eisenach
(Thüringen)
GermanyRekrutierend» Google-Maps
University of Frankfurt - Department of Urology
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
University Medical Center Halle (Saale)
06120 Halle
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
University Medical Center Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Asklepios Clinic Altona Hamburg
22763 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
University Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
University Medical Center LMU Munich - Campus Grosshadern, Urologische Klinik und Poliklinik Marchionnish R. 15
81377 München
(Bayern)
GermanyRekrutierend» Google-Maps
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandRekrutierend» Google-Maps
MVP MP Saaletal Saalfeld/Saale
7318 Saalfeld
(Thüringen)
GermanyRekrutierend» Google-Maps
Klinikum Sindelfingen-Boblingen
71065 Sindelfingen
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Diakonissenkrankenhaus und Paulinenhilfe GGMBH
70176 Stuttgart
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Dept of Urology, Eberhard-Karls-University Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Kepler University Hospital - Urology
4020 Linz
AustriaRekrutierend» Google-Maps
Universitatsklinikum fur Urologie und Andrologie
5020 Salzburg
AustriaRekrutierend» Google-Maps
CHU UCL Namur/Site Sainte Elisabeth
5000 Namur
BelgiumRekrutierend» Google-Maps
Krajská Nemocnice Liberec, A.S., Komplexní Onkologické Centrum
460 63 Liberec
CzechiaRekrutierend» Google-Maps
Radiotherapy and Oncology Department FNKV
100 34 Prague
CzechiaRekrutierend» Google-Maps
Thomayerova Nemocnice, Onkologická Klinika 1. LF UK A TN
140 59 Praha 4
CzechiaRekrutierend» Google-Maps
Hospital na Bulovce, Institut of Radiation Oncology
18081 Praha
CzechiaRekrutierend» Google-Maps
Centre Hospitalier Universitaire
25030 Besançon
FranceRekrutierend» Google-Maps
University Hospital Saint André
33075 Bordeaux
FranceRekrutierend» Google-Maps
Grenoble University Hospital
38043 Grenoble
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyson Sud
69495 Pierre-Bénite
FranceRekrutierend» Google-Maps
Institut de Cancérologie Lucien Neuwirth (ICLN)
Saint-Priest-en-Jarez
FranceRekrutierend» Google-Maps
Strasbourg Oncologie Liberale
67000 Strasbourg
FranceRekrutierend» Google-Maps
Hôpitaux Universitaires de Strasbourg
67091 Strasbourg
FranceRekrutierend» Google-Maps
Dep. Medical Oncology, University Hospital of Ioannina
45500 Ioánnina
GreeceRekrutierend» Google-Maps
Interbalkan Medical Center
57001 Thessaloníki
GreeceRekrutierend» Google-Maps
Azienda Ospedaliera S.Orsola Malpighi di Bologna
40138 Bologna
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale Dei
20133 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria di Modena
41124 Modena
ItalyRekrutierend» Google-Maps
National Cancer Institute "Fondazione G. Pascale" IRCCS
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero-Universitaria di Parma
43126 Parma
ItalyRekrutierend» Google-Maps
IRCCS Azienda Usl Di Reggio Emilia
42123 Reggio Emilia
ItalyRekrutierend» Google-Maps
UOC Oncologia Azienda Ospedaliera Sant-Andrea
00189 Rome
ItalyRekrutierend» Google-Maps
IRCCS Ospedale casa Sollievo Della Sofferenza
71013 San Giovanni Rotondo
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera S. Maria
5100 Terni
ItalyNoch nicht rekrutierend» Google-Maps
Presidio Ospedaliero Santa Chiara
38122 Trento
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Integrata Verona
37134 Verona
ItalyRekrutierend» Google-Maps
Albert Schweitzar Ziekenhuis
3318 AT Dordrecht
NetherlandsZurückgezogen» Google-Maps
Haaglanden Medical Centre
2262 BA Leidschendam
NetherlandsRekrutierend» Google-Maps
Szpital Kliniczny Przemienienia Panskiego w Poznaniu
61848 Poznań
PolandRekrutierend» Google-Maps
Wojskowy Instytut Medyczny, Klinika Onkologii
04141 Warsaw
PolandRekrutierend» Google-Maps
Dolnoslaskie Centrum Onkologii
11400 Wrocław
PolandRekrutierend» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Lucus Augusti
27003 Lugo
SpainRekrutierend» Google-Maps
Hospital Virgen de la Victoria
29017 Málaga
SpainRekrutierend» Google-Maps
Hospital Universitario Central de Asturias (Huca)
33011 Oviedo
SpainRekrutierend» Google-Maps
Hospital Son Llatzer
07198 Palma De Mallorca
SpainRekrutierend» Google-Maps
Hospital Universitario Son Espases
7120 Palma De Mallorca
SpainRekrutierend» Google-Maps
Complejo Hospitalario De Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitari Parc Tauli
8208 Sabadell
SpainRekrutierend» Google-Maps
Complejo Hospitalario Universitario de Compostela
15706 Santiago De Compostela
SpainRekrutierend» Google-Maps
Hospital Clinico Lozano Blesa
50009 Zaragoza
SpainRekrutierend» Google-Maps
East Kent Hospitals University NHS Foundation Trust
CT1 3NG Canterbury
United KingdomRekrutierend» Google-Maps
Royal Derby Hospital
DE22 3NE Derby
United KingdomRekrutierend» Google-Maps
East and North Hertfordshire
HA62RN Middlesex
United KingdomRekrutierend» Google-Maps
Rosemere Cancer Centre, Royal Preston Hospital
PR2 9HT Preston
United KingdomRekrutierend» Google-Maps
Frimley Health NHS Foundation Trust - Wezham Park and Heatherwood Hospitals
SL2 4HL Slough
United KingdomAbgebrochen» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The study will follow the real-life management of patients in clinical practice. Visits will

take place according to the study site's clinical practice. Cabozantinib is to be

administered as directed by the investigator according to the study site's usual clinical

practice and the Cabometyx™ Summary of Product Characteristics (SmPC).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥18 years old

- Has a diagnosis of advanced RCC

- Has received at least one prior VEGF-targeted therapy

- For whom the treating physician has decided to start treatment with cabozantinib

tablets prior to inclusion

- No previous exposure to cabozantinib prior to inclusion

- Not concurrently involved in an interventional study

- Consents to participate in this noninterventional study

Exclusion Criteria:

- There are no exclusion criteria for this study.

Studien-Rationale

Primary outcome:

1. The proportion of subjects with dose modifications due to AEs (Time Frame - 12 months)



Secondary outcome:

1. Reason for cabozantinib dose modification (any modification, reduction, temporary interruption or discontinuation) (Time Frame - 12 months):
Percentage of subjects with the following reasons - Disease progression, Adverse event, Subject non-compliance, Treatment resumed or re escalated, Subject decision, Clinical / investigator decision, Other

2. Description of number of cabozantinib dose modifications (any modification, reduction, temporary interruption, increase or discontinuation) (Time Frame - 12 months)

3. Median time to first cabozantinib dose modification (any modification, reduction, temporary interruption, increase or discontinuation) due to AEs and for any reason (Time Frame - 12 months)

4. Description of cabozantinib starting dose (combination of dose per intake and frequency) (Time Frame - 12 months)

5. Description of daily dose of cabozantinib received (Time Frame - 12 months)

6. Description of cabozantinib dose intensity (average daily dose compared to starting dose) (Time Frame - 12 months)

7. Duration of cabozantinib treatment (expressed as mean and median time to end of treatment) (Time Frame - 12 months)

8. Proportion of subjects with concomitant radiotherapies (Time Frame - 12 months)

9. Description of systemic therapy (drug name) planned following cabozantinib discontinuation (Time Frame - 12 months):
Percentage of subjects treated with the following drugs: Sunitinib, Pazopanib, Axitinib, Sorafenib, Bevacizumab, Cytokines, Everolimus, Lenvatinib, Nivolumab, Tivozanib, Experimental trial drug, Other, Unknown)

10. Overall best response (Time Frame - 12 months):
Per investigator assessment

11. Median Progression Free Survival (PFS) time (Time Frame - 12 months):
Defined as the time between the start date of cabozantinib and the date of progression or death. Clinical and radiographic (assessed by the investigator based on RECIST 1.1)

12. Overall Survival (OS) rate at the end of the study (Time Frame - 12 months)

13. Health care resource utilisation: number of visits to health care professionals (hospitalisation, surgical procedure, emergency room, physician, homecare by nurse) associated with the management of treatment-related AEs (Time Frame - 12 months)

14. Health care resource utilisation: Description of concomitant medications (by drug class and preferred name) associated with the management of treatment-related AEs (Time Frame - 12 months)

15. Health care resource utilisation: Description of number of unplanned laboratory tests associated with the management of treatment-related AEs (Time Frame - 12 months)

Studien-Arme

  • Second line therapy
    Data collection
  • Third and later line therapy
    Data collection

Geprüfte Regime

  • Data collection:
    Only available evaluations as decided by the investigator based on local clinical practice will be collected.

Quelle: ClinicalTrials.gov


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