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NCT Number: NCT01869400

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

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.

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Key information

Conditions

Recurrent Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Praxis und Tagesklinik für gynäkologische Onkologie, Ebersberg, Bavaria, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. safety and tolerability data of the study therapy

    Time frame: during Yondelis-PLD-therapy

    Number of patients with adverse events

Secondary outcomes

  1. "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

    Number of patients with CR, PR, SD as best response

  2. Treatment duration

    Time frame: during Yondelis-PLD-therapy

    Time between first and last cycle of each patient

  3. Observation of the number of the therapy cycles applied

    Time frame: during Yondelis-PLD-therapy

    Number of applied therapy cycles

  4. Time to next treatment

    Time frame: 1 Year after last Yondelis-PLD-Therapy

    Date from last Yondelis-PLD-treatment to date of next treatment

  5. Progression free survival

    Time frame: 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

  6. Duration of response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

PharmaMar, Spain

Industry

Registry information

Official study title

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

Acronym: NIS-OvaYond

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 5, 2013
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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