Clinical trial NCT01869400: An Observational Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
Official title: An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Ovarian Cancer
Lead sponsor: PharmaMar, Spain
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitales and medical practices in Germany

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.

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

Primary outcomes:
measure: safety and tolerability data of the study therapy
timeFrame: during Yondelis-PLD-therapy
Secondary outcomes:
measure: "Real life data" - clinical and / or serological (CA 125) response and Stable disease rates
timeFrame: till one year after last date of Yondelis-PLD-therapy
measure: Treatment duration
timeFrame: during Yondelis-PLD-therapy
measure: Observation of the number of the therapy cycles applied
timeFrame: during Yondelis-PLD-therapy
measure: Time to next treatment
timeFrame: 1 Year after last Yondelis-PLD-Therapy
measure: Progression free survival
timeFrame: till one year after last date of Yondelis-PLD-therapy
measure: Duration of response
timeFrame: till one year after last date of Yondelis-PLD-therapy
Other outcomes:
Locations:
city: Ebersberg
country: Germany
facility: Praxis und Tagesklinik für gynäkologische Onkologie
state: Bayern
city: Rotenburg
country: Germany
facility: Diakoniekrankenhaus, Gynäkologie und Geburtshilfe
state: Lower Saxony
Study officials:
affiliation: Klinikum der Friedrich-Schiller-Universität Jena, Klinik für Frauenheilkunde, Bachstr. 18, D-07743 Jena
name: Ingo Runnebaum, Prof. Dr.
role: STUDY_CHAIR
References: