Clinical trial NCT02825420: Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed Ovarian Cancer
Lead sponsor: PharmaMar
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.

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


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Progression Free Survival by Prior Antiangiogenic Treatment
timeFrame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Progression Free Survival by BRCA1/2 Status
timeFrame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Progression Free Survival by Platinum Sensitivity
timeFrame: From Day 1 to the earliest date of disease progression as reported by the investigator or death, up to 4.5 years (Jan 2015 to Sept 2019)
Secondary outcomes:
measure: Best Tumor Response
timeFrame: From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Best Response by Prior Antiangiogenic Treatment
timeFrame: From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Overall Survival
timeFrame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Overall Survival by Prior Antiangiogenic Treatment
timeFrame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Overall Survival by BRCA1/2 Status
timeFrame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Overall Survival by Platinum Sensitivity
timeFrame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Change From Baseline to Best Post-baseline ECOG Performance Status Score
timeFrame: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
measure: Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment
timeFrame: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O.L.V. Aalst
state: Flandes
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: Flandes
city: La Louviere
country: Belgium
facility: Centre Hospitalier de Jolimont
state: Henao
city: Mons
country: Belgium
facility: CHU Ambroise-Paré
state: Henao
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie Picarde
state: Henao
city: Bruxelles
country: Belgium
facility: CHIREC - Cancer Institute
city: Dijon
country: France
facility: Centre d'Oncologie et de Radiothérapie du Parc
state: Borgoña
city: Toulon
country: France
facility: Clinique Saint Jean
state: Provence
city: Neuilly sur Seine
country: France
facility: Institut d'Oncologie Hauts-de-Seine Nord
state: Seine
city: Le Mans
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
state: Sharte
city: Amiens
country: France
facility: Clinique de l'Europe
city: Challes Les Eaux
country: France
facility: Medipole de Savoie
city: Osny
country: France
facility: Oncologie médicale du Val d'Oise
city: Paris
country: France
facility: Hôpital Saint Louis
city: Strasbourg
country: France
facility: Strasbourg Oncologie Libérale Centre de radiothérapie
city: Westerstede
country: Germany
facility: Onkologie Westerstede
state: Ammerland
city: Kempten
country: Germany
facility: Klinikum Kempten
state: Baviera
city: Solingen
country: Germany
facility: Städtisches Klinikum
state: Düsseldorf
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt Frauenklinik
state: Hesse
city: Wetzlar
country: Germany
facility: Brustzentrum
state: Hesse
city: Homburg/Saar
country: Germany
facility: Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
state: Homburg
city: Dresden
country: Germany
facility: Onkologische Schwerpunktpraxis
state: Sajonia
city: Georgsmarienhutte
country: Germany
facility: Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie
state: Sajonia
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde
city: Bottrop
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Dortmund
country: Germany
facility: Städt. Klinik Dortmund, Frauenklinik
city: München
country: Germany
facility: Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH
city: Scheibenberg
country: Germany
facility: Praxis Dr. Rene Schubert
city: Torgau
country: Germany
facility: Kreiskrankenhaus Torgau
city: Monserrato
country: Italy
facility: Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula
state: Cerdeña
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo Della Sofferenza
state: Foggia
city: Aviano
country: Italy
facility: Centro Riferimento Oncologico di Aviano
state: Pordenone
city: Bergamo
country: Italy
facility: Ospedale S.Maria d. Misericordia
state: Savona
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II IRCCS
city: Benevento
country: Italy
facility: Azienda Ospedaliera Gaetano Rummo
city: Bergamo
country: Italy
facility: A. O. Papa Giovanni XXIII
city: Como
country: Italy
facility: Ospedale S. Anna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milano
country: Italy
facility: A.O. Sacco
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Pascale
city: Parma
country: Italy
facility: A.O.U. di Parma
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli Università Cattolica di Roma
city: Torino
country: Italy
facility: Ospedale Gradenigo
city: Treviso
country: Italy
facility: Ospedale Cà Foncello
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
state: Jaen
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Doctor Negrín
state: Las Palmas
city: Leon
country: Spain
facility: Hospital de León
state: León
city: Parla
country: Spain
facility: Hospital Infanta Cristina
state: Madrid
city: Vigo
country: Spain
facility: Hospital Xeral-Cíes de Vigo
state: Pontevedra
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario de La Laguna
state: Santa Cruz De Tenerife
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital de Reus
city: La Coruña
country: Spain
facility: Complejo Hospitalario de La Coruña
city: Madrid
country: Spain
facility: MD Anderson
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
Study officials:
affiliation: PharmaMar
name: María José Pontes
role: STUDY_CHAIR
References: