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Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients (NIMES-ROC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02825420
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 1, 2020
Information provided by (Responsible Party):

Brief Summary:
Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of previous use of an antiangiogenic drug

Condition or disease Intervention/treatment
Relapsed Ovarian Cancer Drug: trabectedin

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Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: NonInterventional, Multicenter, Prospective, European Study to Describe the Effectiveness of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients According to SmPC Regardless of Previous Use of an Antiangiogenic Drug
Study Start Date : June 2015
Actual Primary Completion Date : August 2019
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Trabectedin

Primary Outcome Measures :
  1. PFS after trabectedin + PLD therapy [ Time Frame: 18 months ]
    PFS after trabectedin + PLD therapy for the treatment of relapsed ovarian cancer according to SmPC, while describing patients who were pretreated with an antiangiogenic drug and those not pretreated in real-life clinical practice

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.

Inclusion Criteria:

  • Women aged 18 years or older.
  • Presence of platinum-sensitive relapsed ovarian cancer.
  • Treatment and treated indication according to local label SmPC and reimbursement for trabectedin and PLD treatment.
  • Prior treatment with a minimum of 1 cycle of trabectedin + PLD according to SmPC before inclusion in the study, and no more than 3 previous treatment lines.
  • Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02825420

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Sponsors and Collaborators
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Study Chair: María José Pontes PharmaMar
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Responsible Party: PharmaMar Identifier: NCT02825420    
Other Study ID Numbers: ET-D-031-14
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents