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.
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.
Study Type
OBSERVATIONAL
Enrollment
83
Praxis und Tagesklinik für gynäkologische Onkologie
Ebersberg, Bavaria, Germany
Diakoniekrankenhaus, Gynäkologie und Geburtshilfe
Rotenburg (Wümme), Lower Saxony, Germany
safety and tolerability data of the study therapy
Number of patients with adverse events
Time frame: during Yondelis-PLD-therapy
"Real life data" - clinical and / or serological (CA 125) response and Stable disease rates
Number of patients with CR, PR, SD as best response
Time frame: till one year after last date of Yondelis-PLD-therapy
Treatment duration
Time between first and last cycle of each patient
Time frame: during Yondelis-PLD-therapy
Observation of the number of the therapy cycles applied
Number of applied therapy cycles
Time frame: during Yondelis-PLD-therapy
Time to next treatment
Date from last Yondelis-PLD-treatment to date of next treatment
Time frame: 1 Year after last Yondelis-PLD-Therapy
Progression free survival
Difference between date of first documentation of "PD" and the date of first Yondelis® + PLD application
Time frame: till one year after last date of Yondelis-PLD-therapy
Duration of response
Time in months from first assessment of CR or PR until the first date of PD or death.
Time frame: till one year after last date of Yondelis-PLD-therapy
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