Recurrent Ovarian Cancer
Conditions
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.
Interventions
None listed
Sponsors
PharmaMar, Spain
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability data of the study therapy | during Yondelis-PLD-therapy | Number of patients with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment duration | during Yondelis-PLD-therapy | Time between first and last cycle of each patient |
| Observation of the number of the therapy cycles applied | during Yondelis-PLD-therapy | Number of applied therapy cycles |
| Real life data - clinical and / or serological (CA 125) response and Stable disease rates | till one year after last date of Yondelis-PLD-therapy | Number of patients with CR, PR, SD as best response |
| Progression free survival | 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 | 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. |
| Time to next treatment | 1 Year after last Yondelis-PLD-Therapy | Date from last Yondelis-PLD-treatment to date of next treatment |
Countries
Germany
Outcome results
None listed