Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients
NCT ID: NCT02825420
Last Updated: 2021-10-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
220 participants
OBSERVATIONAL
2015-07-28
2019-09-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
trabectedin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PharmaMar
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
María José Pontes
Role: STUDY_CHAIR
PharmaMar
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
O.L.V. Aalst
Aalst, Flanders, Belgium
AZ Maria Middelares
Ghent, Flanders, Belgium
Centre Hospitalier de Jolimont
La Louvière, Henao, Belgium
CHU Ambroise-Paré
Mons, Henao, Belgium
Centre Hospitalier de Wallonie Picarde
Tournai, Henao, Belgium
CHIREC - Cancer Institute
Brussels, , Belgium
Centre d'Oncologie et de Radiothérapie du Parc
Dijon, Borgoña, France
Clinique Saint Jean
Toulon, Provence-Alpes-Côte d'Azur Region, France
Institut d'Oncologie Hauts-de-Seine Nord
Neuilly-sur-Seine, Seine, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sharte, France
Clinique de l'Europe
Amiens, , France
Medipole de Savoie
Challes-les-Eaux, , France
Oncologie médicale du Val d'Oise
Osny, , France
Hôpital Saint Louis
Paris, , France
Strasbourg Oncologie Libérale Centre de radiothérapie
Strasbourg, , France
Onkologie Westerstede
Westerstede, Ammerland, Germany
Klinikum Kempten
Kempten (Allgäu), Bavaria, Germany
Städtisches Klinikum
Solingen, Düsseldorf, Germany
Klinikum Darmstadt Frauenklinik
Darmstadt, Hesse, Germany
Brustzentrum
Wetzlar, Hesse, Germany
Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Homburg/Saar, Homburg, Germany
Onkologische Schwerpunktpraxis
Dresden, Saxony, Germany
Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie
Georgsmarienhutte, Saxony, Germany
Klinikum St. Marien Amberg
Amberg, , Germany
Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde
Arnsberg, , Germany
Onkologische Gemeinschaftspraxis
Bottrop, , Germany
Städt. Klinik Dortmund, Frauenklinik
Dortmund, , Germany
Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH
München, , Germany
Praxis Dr. Rene Schubert
Scheibenberg, , Germany
Kreiskrankenhaus Torgau
Torgau, , Germany
IRCCS Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Centro Riferimento Oncologico di Aviano
Aviano, Pordenone, Italy
Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula
Monserrato, Sardinia, Italy
Ospedale S.Maria d. Misericordia
Bergamo, Savona, Italy
Ospedale Cardinal Massaia
Asti, , Italy
Istituto Tumori Giovanni Paolo II IRCCS
Bari, , Italy
Azienda Ospedaliera Gaetano Rummo
Benevento, , Italy
A. O. Papa Giovanni XXIII
Bergamo, , Italy
Ospedale S. Anna
Como, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
A.O. Sacco
Milan, , Italy
Istituto Nazionale Tumori IRCCS Pascale
Napoli, , Italy
A.O.U. di Parma
Parma, , Italy
Policlinico Universitario Agostino Gemelli Università Cattolica di Roma
Roma, , Italy
Ospedale Gradenigo
Torino, , Italy
Ospedale Cà Foncello
Treviso, , Italy
Complejo Hospitalario de Jaén
Jaén, Jaen, Spain
Hospital Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital de León
León, León, Spain
Hospital Infanta Cristina
Parla, Madrid, Spain
Hospital Xeral-Cíes de Vigo
Vigo, Pontevedra, Spain
Hospital Universitario de La Laguna
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital de Galdakao
Galdakao, Vizcaya, Spain
Complejo Hospitalario de La Coruña
A Coruña, , Spain
Hospital Sant Pau
Barcelona, , Spain
Hospital de Reus
Barcelona, , Spain
MD Anderson
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
Hospital Virgen Macarena
Seville, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ET-D-031-14
Identifier Type: -
Identifier Source: org_study_id