An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer (NIS-OvaYond)
Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population.
Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials.
This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.
|Recurrent Ovarian Cancer|
|Study Design:||Observational Model: Other
Time Perspective: Prospective
|Official Title:||An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer|
- safety and tolerability data of the study therapy [ Time Frame: during Yondelis-PLD-therapy ]Number of patients with adverse events
- "Real life data" - clinical and / or serological (CA 125) response and Stable disease rates [ Time Frame: till one year after last date of Yondelis-PLD-therapy ]Number of patients with CR, PR, SD as best response
- Treatment duration [ Time Frame: during Yondelis-PLD-therapy ]Time between first and last cycle of each patient
- Observation of the number of the therapy cycles applied [ Time Frame: during Yondelis-PLD-therapy ]
- Time to next treatment [ Time Frame: 1 Year after last Yondelis-PLD-Therapy ]
- Progression free survival [ Time Frame: till one year after last date of Yondelis-PLD-therapy ]Difference between date of first documentation of "PD" and the date of first Yondelis® + PLD application
- Duration of response [ Time Frame: till one year after last date of Yondelis-PLD-therapy ]Time in months from first assessment of CR or PR until the first date of PD or death.
|Actual Study Start Date:||April 2013|
|Study Completion Date:||February 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Yondelis-Pegylated liposomal Doxorubicin
30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869400
|Praxis und Tagesklinik für gynäkologische Onkologie|
|Ebersberg, Bayern, Germany, 85567|
|Diakoniekrankenhaus, Gynäkologie und Geburtshilfe|
|Rotenburg, Lower Saxony, Germany, 27356|
|Study Chair:||Ingo Runnebaum, Prof. Dr.||Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena|