A retrospective study of characteristics, patterns of care, healthcare resource utilisation and event histories in subjects with recurrent ovarian cancer in France and Germany. TROCADERO (Treatment of Recurrent Ovarian Cancer And Description of Events, Resources and Outcomes).TROCADERO (Treatment of Recurrent Ovarian Cancer And Description of Events, Resources and Outcomes)
Titel der Studie/Acronym
A retrospective study of characteristics, patterns of care, healthcare resource utilisation and event histories in subjects with recurrent ovarian cancer in France and Germany. TROCADERO (Treatment of Recurrent Ovarian Cancer And Description of Events, Resources and Outcomes).TROCADERO (Treatment of Recurrent Ovarian Cancer And Description of Events, Resources and Outcomes)
Zielsetzung/Fragestellung
In recurrent ovarian cancer subjects, to evaluate the platinum-free interval between partially platinum-sensitive subjects who receive platinum-containing treatment following first recurrence and those who do not.
Indikation
- Ovarialkarzinom
Wirkstoff
- Panitumumab (deutsch)
Handelsname(n)
Vectibix / Panitumumab
Studie von Zulassungsbehörde gefordert oder von G-BA oder anderer Institution empfohlen
Nein
Studientyp
Vergleichende Untersuchung
Art der Studienzentren
Klinik, Praxis/niedergelassener Bereich
Untersuchung wird nur in D durchgeführt
Nein
Untersuchung wird auch in anderen Ländern mit gleichem Beobachtungsplan durchgeführt
Ja
primäre Zielgröße(n)
PFI (Progression free intervall)
Angaben zur Fallzahlbegründung
"In order to ensure their adequate representation, at least 100 partially platinum-sensitive subjects will be
enrolled, including 50 partially platinum subjects treated with platinum at first recurrence and 50 partially
platinum subjects treated with non platinum at first recurrence. It is assumed that the PFI values within
each subcategory of the partially platinum patient subgroup (partially platinum sensitive treated with
platinum at first recurrence, partially platinum sensitive treated with non platinum at first recurrence) are
normally distributed with means of 10.5 and 7.5 months and a common standard deviation of 1. Under
these assumptions, 50 subjects per partially platinum sensitive subcategory are expected to provide a
confidence interval about the hypothesized mean PFI time of half-width 0.28 within each subcategory of
partially platinum sensitive subjects. This level of precision is expected to be sufficient for the descriptive
purposes of this study.
continuous endpoints will be summarized using descriptive statistics."
Geplante Anzahl vorgesehener Studienzentren: für die Untersuchung insgesamt
30
Geplante Anzahl vorgesehener Studienzentren: Anzahl in Deutschland
15
Geplante Patientenzahl: für die Untersuchung insgesamt
300
Geplante Patientenzahl: Anzahl in Deutschland
150
Geplante Patientenzahl pro Praxis/Zentrum
10
Beginn der Studie
07.09.2012
Geplante Beobachtungsdauer je Patient
42 Monate
Geplante Dauer der Studie
7 Monate
Studiennummer
20110178
Kontaktperson
Petke, Sabine
Senior Associate Clinical Operations Management
Amgen GmbH
Hanauer Straße 1
80992 München
Deutschland
Telefon: +49 89 14 90 96 - 1598
Telefax: +49 89 14 90 96 - 2598
Unternehmen
AMGEN GmbH
Hanauer Str. 1
80992 München
Deutschland
Stand der Information
16.10.2014
Status der Studie
Studie bereits abgeschlossen
