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:||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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Number of patients with CR, PR, SD as best response
- Treatment duration [ Time Frame: during Yondelis-PLD-therapy ] [ Designated as safety issue: No ]Time between first and last cycle of each patient
- Observation of the number of the therapy cycles applied [ Time Frame: during Yondelis-PLD-therapy ] [ Designated as safety issue: No ]
- Time to next treatment [ Time Frame: 1 Year after last Yondelis-PLD-Therapy ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: till one year after last date of Yondelis-PLD-therapy ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Time in months from first assessment of CR or PR until the first date of PD or death.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||February 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
Yondelis® (trabectedin) was approved (in combination with PLD) in the European community in December 2009 for the treatment of platinum-sensitive ovarian cancer relapse. Based on the outcomes of study OVA-301, this non-interventional study will investigate the role of a platinum-free treatment regimen in patients with progressive ovarian cancer relapsing > 6 months after completing previous platinum-based chemotherapy. In particular, this study aims at collecting the "real-life" data with regard to the response and the influence of the mentioned therapy on the "tumor related events", to objectify the value of palliative care.
|Praxis Dr. Gröll de Rivera|
|Grafing, Bayern, Germany, 85567|
|Study Chair:||Ingo Runnebaum, Prof. Dr.||Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena|