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

Completed

• Conditions: Relapsed Ovarian Cancer

• Registration Number: NCT02825420
• Lead Sponsor: PharmaMar

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-28
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Status Verified: 2021-07
• Results First Submitted: 2021-07-28
• Results First Submitted QC: 2021-09-30
• Last Update Submitted: 2021-09-30
• Results First Posted: 2021-10-29
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	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)	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.
Progression Free Survival by Prior Antiangiogenic Treatment	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)	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.
Progression Free Survival by BRCA1/2 Status	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)	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.
Progression Free Survival by Platinum Sensitivity	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)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival by Prior Antiangiogenic Treatment	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)	Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Overall Survival by BRCA1/2 Status	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)	Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Best Tumor Response	From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)	Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): 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
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)	Complete response (CR): Disappearance of all target lesions; Partial response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; Progressive disease (PD): 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
Overall Survival by Platinum Sensitivity	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)	Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.
Change From Baseline to Best Post-baseline ECOG Performance Status Score	Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)	Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment	Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)	Eastern Cooperative Oncology Group performance status (ECOG): 0 Fully active, able to carry on all pre-disease performance without restriction; 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours; 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours; 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair; 5 Dead
Overall Survival	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)	Overall Survival time was calculated as the number of days from Day 1 to death. Time to death was summarized in months. Patients who did not die (no record of death) or were lost to follow up were censored at the date of last contact/last date known alive.

Trial Locations

Locations (65)

Brustzentrum; 🇩🇪 Wetzlar, Hesse, Germany

Ospedale S.Maria d. Misericordia; 🇮🇹 Bergamo, Savona, Italy

Hospital Universitario de La Laguna; 🇪🇸 San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

A.O. Sacco; 🇮🇹 Milano, Italy

Azienda Ospedaliera Gaetano Rummo; 🇮🇹 Benevento, Italy

A. O. Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Ospedale S. Anna; 🇮🇹 Como, Italy

Istituto Nazionale Tumori IRCCS Pascale; 🇮🇹 Napoli, Italy

A.O.U. di Parma; 🇮🇹 Parma, Italy

Hôpital Saint Louis; 🇫🇷 Paris, France

Centre Hospitalier de Wallonie Picarde; 🇧🇪 Tournai, Henao, Belgium

Centre Hospitalier de Jolimont; 🇧🇪 La Louviere, Henao, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Flandes, Belgium

O.L.V. Aalst; 🇧🇪 Aalst, Flandes, Belgium

CHIREC - Cancer Institute; 🇧🇪 Bruxelles, Belgium

CHU Ambroise-Paré; 🇧🇪 Mons, Henao, Belgium

Centre d'Oncologie et de Radiothérapie du Parc; 🇫🇷 Dijon, Borgoña, France

Clinique Saint Jean; 🇫🇷 Toulon, Provence, 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

Oncologie médicale du Val d'Oise; 🇫🇷 Osny, France

Medipole de Savoie; 🇫🇷 Challes Les Eaux, France

Strasbourg Oncologie Libérale Centre de radiothérapie; 🇫🇷 Strasbourg, France

Onkologie Westerstede; 🇩🇪 Westerstede, Ammerland, Germany

Städtisches Klinikum; 🇩🇪 Solingen, Düsseldorf, Germany

Klinikum Kempten; 🇩🇪 Kempten, Baviera, Germany

Klinikum Darmstadt Frauenklinik; 🇩🇪 Darmstadt, Hesse, Germany

Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin; 🇩🇪 Homburg/Saar, Homburg, Germany

Onkologische Schwerpunktpraxis; 🇩🇪 Dresden, Sajonia, Germany

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie; 🇩🇪 Georgsmarienhutte, Sajonia, Germany

Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde; 🇩🇪 Arnsberg, Germany

Klinikum St. Marien Amberg; 🇩🇪 Amberg, 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

Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula; 🇮🇹 Monserrato, Cerdeña, Italy

Centro Riferimento Oncologico di Aviano; 🇮🇹 Aviano, Pordenone, Italy

Ospedale Cardinal Massaia; 🇮🇹 Asti, Italy

Istituto Tumori Giovanni Paolo II IRCCS; 🇮🇹 Bari, Italy

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, 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; 🇪🇸 Leon, León, Spain

Hospital Xeral-Cíes de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Hospital Infanta Cristina; 🇪🇸 Parla, Madrid, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Vizcaya, Spain

Hospital de Galdakao; 🇪🇸 Galdakao, Vizcaya, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Hospital de Reus; 🇪🇸 Barcelona, Spain

Complejo Hospitalario de La Coruña; 🇪🇸 La Coruña, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

MD Anderson; 🇪🇸 Madrid, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Son Llatzer; 🇪🇸 Palma de Mallorca, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain