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

NCT02825420 | Completed Results

• 1 other identifier: ET-D-031-14
• Study Type: observational
• Target: 220
• Locations: 5 countries
• Sites: 65

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

Conditions

Relapsed Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• Progression-Free Survival

  PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  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)

• Progression Free Survival by Prior Antiangiogenic Treatment

  PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  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)

• Progression Free Survival by BRCA1/2 Status

  PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  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)

• Progression Free Survival by Platinum Sensitivity

  PFS was defined as time (in months) from Day 1 to the earliest date of disease progression as reported by the investigator or death, regardless of cause, (whichever is first). Patients with no reported disease progression and alive were censored at last contact date/last date known alive. PFS was calculated as the date of progressive disease or death minus date of Day 1, and the result in days was converted to months. All tumor assessment dates were based on the actual imaging dates reported by the investigator. Progressive disease (PD) defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  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 (8)

• Best Tumor Response

  From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)

• Best Response by Prior Antiangiogenic Treatment

  From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)

• Overall Survival

  From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)

• Overall Survival by Prior Antiangiogenic Treatment

  From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)

• Overall Survival by BRCA1/2 Status

  From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)

Interventions

trabectedin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.

You may qualify if:

• 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.
• Written informed consent indicating that patients understand the purpose and procedures and are willing to participate in the study.

You may not qualify if:

• None

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (65)

O.L.V. Aalst

Aalst, Flanders, 164-9300, Belgium

Location

AZ Maria Middelares

Ghent, Flanders, 1026-9000, Belgium

Location

Centre Hospitalier de Jolimont

La Louvière, Henao, 7100, Belgium

Location

CHU Ambroise-Paré

Mons, Henao, 02-7000, Belgium

Location

Centre Hospitalier de Wallonie Picarde

Tournai, Henao, 807500, Belgium

Location

CHIREC - Cancer Institute

Brussels, 32-1180, Belgium

Location

Centre d'Oncologie et de Radiothérapie du Parc

Dijon, Borgoña, 21000, France

Location

Clinique Saint Jean

Toulon, Provence-Alpes-Côte d'Azur Region, 83000, France

Location

Institut d'Oncologie Hauts-de-Seine Nord

Neuilly-sur-Seine, Seine, France

Location

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, Sharte, 72000, France

Location

Clinique de l'Europe

Amiens, 80000, France

Location

Medipole de Savoie

Challes-les-Eaux, 73190, France

Location

Oncologie médicale du Val d'Oise

Osny, 95520, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Strasbourg Oncologie Libérale Centre de radiothérapie

Strasbourg, 67000, France

Location

Onkologie Westerstede

Westerstede, Ammerland, 26655, Germany

Location

Klinikum Kempten

Kempten (Allgäu), Bavaria, 87439, Germany

Location

Städtisches Klinikum

Solingen, Düsseldorf, 42653, Germany

Location

Klinikum Darmstadt Frauenklinik

Darmstadt, Hesse, 64283, Germany

Location

Brustzentrum

Wetzlar, Hesse, 35578, Germany

Location

Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin

Homburg/Saar, Homburg, 66424, Germany

Location

Onkologische Schwerpunktpraxis

Dresden, Saxony, 1307, Germany

Location

Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie

Georgsmarienhutte, Saxony, 49124, Germany

Location

Klinikum St. Marien Amberg

Amberg, 92224, Germany

Location

Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde

Arnsberg, 59759, Germany

Location

Onkologische Gemeinschaftspraxis

Bottrop, 46236, Germany

Location

Städt. Klinik Dortmund, Frauenklinik

Dortmund, 44137, Germany

Location

Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH

München, 80804, Germany

Location

Praxis Dr. Rene Schubert

Scheibenberg, 09481, Germany

Location

Kreiskrankenhaus Torgau

Torgau, 04860, Germany

Location

IRCCS Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Centro Riferimento Oncologico di Aviano

Aviano, Pordenone, 33081, Italy

Location

Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula

Monserrato, Sardinia, 09042, Italy

Location

Ospedale S.Maria d. Misericordia

Bergamo, Savona, 24047, Italy

Location

Ospedale Cardinal Massaia

Asti, 14100, Italy

Location

Istituto Tumori Giovanni Paolo II IRCCS

Bari, 70124, Italy

Location

Azienda Ospedaliera Gaetano Rummo

Benevento, 82100, Italy

Location

A. O. Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Ospedale S. Anna

Como, 22020, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

A.O. Sacco

Milan, 20157, Italy

Location

Istituto Nazionale Tumori IRCCS Pascale

Napoli, 80131, Italy

Location

A.O.U. di Parma

Parma, 43126, Italy

Location

Policlinico Universitario Agostino Gemelli Università Cattolica di Roma

Roma, 00168, Italy

Location

Ospedale Gradenigo

Torino, 10153, Italy

Location

Ospedale Cà Foncello

Treviso, 31100, Italy

Location

Complejo Hospitalario de Jaén

Jaén, Jaen, 23007, Spain

Location

Hospital Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Hospital de León

León, León, 28040, Spain

Location

Hospital Infanta Cristina

Parla, Madrid, 06080, Spain

Location

Hospital Xeral-Cíes de Vigo

Vigo, Pontevedra, 36204, Spain

Location

Hospital Universitario de La Laguna

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital de Galdakao

Galdakao, Vizcaya, 48960, Spain

Location

Complejo Hospitalario de La Coruña

A Coruña, 15006, Spain

Location

Hospital Sant Pau

Barcelona, 08026, Spain

Location

Hospital de Reus

Barcelona, 43204, Spain

Location

MD Anderson

Madrid, 28033, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, 07198, Spain

Location

Hospital Virgen Macarena

Seville, 41071, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
• Organization: Pharma Mar S.A.

clinicaltrials@pharmamar.com

0034 91846 60 00

Study Officials

• María José Pontes

  PharmaMar

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 7, 2016
• Study Start: July 28, 2015
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: October 29, 2021
• Results First Posted: October 29, 2021

Record last verified: 2021-07

Locations

ES (19); IT (16); BE (6); FR (9); DE (15)