An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer

Conditions
-----------------
Recurrent Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age >18, no upper limit Patients with relapsed platinum-sensitive ovarian cancer Before inclusion in the NIS written informed consent must be given Exclusion Criteria: According to summary of product characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Yondelis-Pegylated liposomal Doxorubicin<br>30 mg/m² PLD i.v. followed by 1.1 mg/m² Yondelis® i.v. 3 h, q3weeks | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability data of the study therapy | Number of patients with adverse events | during Yondelis-PLD-therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real life data - clinical and / or serological (CA 125) response and Stable disease rates | Number of patients with CR, PR, SD as best response | till one year after last date of Yondelis-PLD-therapy | 
| Treatment duration | Time between first and last cycle of each patient | during Yondelis-PLD-therapy | 
| Observation of the number of the therapy cycles applied | Number of applied therapy cycles | during Yondelis-PLD-therapy | 
| Time to next treatment | Date from last Yondelis-PLD-treatment to date of next treatment | 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 | 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. | till one year after last date of Yondelis-PLD-therapy |