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

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

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

Study Overview

• Status: Completed
• Conditions: Relapsed Ovarian Cancer
• Intervention / Treatment: Drug: trabectedin

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 32-1180
    • CHIREC - Cancer Institute
  • Flandes
    • Aalst, Flandes, Belgium, 164-9300
      • O.L.V. Aalst
    • Gent, Flandes, Belgium, 1026-9000
      • AZ Maria Middelares
  • Henao
    • La Louviere, Henao, Belgium, 7100
      • Centre Hospitalier de Jolimont
    • Mons, Henao, Belgium, 02-7000
      • Chu Ambroise-Pare
    • Tournai, Henao, Belgium, 807500
      • Centre Hospitalier de Wallonie Picarde
• France
  • Amiens, France, 80000
    • Clinique de l'Europe
  • Challes Les Eaux, France, 73190
    • Medipole de Savoie
  • Osny, France, 95520
    • Oncologie médicale du Val d'Oise
  • Paris, France, 75010
    • Hopital Saint Louis
  • Strasbourg, France, 67000
    • Strasbourg Oncologie Libérale Centre de Radiothérapie
  • Borgoña
    • Dijon, Borgoña, France, 21000
      • Centre d'Oncologie et de Radiothérapie du Parc
  • Provence
    • Toulon, Provence, France, 83000
      • Clinique Saint Jean
  • Seine
    • Neuilly sur Seine, Seine, France
      • Institut d'Oncologie Hauts-de-Seine Nord
  • Sharte
    • Le Mans, Sharte, France, 72000
      • Clinique Victor Hugo - Centre Jean Bernard
• Germany
  • Amberg, Germany, 92224
    • Klinikum St. Marien Amberg
  • Arnsberg, Germany, 59759
    • Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde
  • Bottrop, Germany, 46236
    • Onkologische Gemeinschaftspraxis
  • Dortmund, Germany, 44137
    • Städt. Klinik Dortmund, Frauenklinik
  • München, Germany, 80804
    • Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH
  • Scheibenberg, Germany, 09481
    • Praxis Dr. Rene Schubert
  • Torgau, Germany, 04860
    • Kreiskrankenhaus Torgau
  • Ammerland
    • Westerstede, Ammerland, Germany, 26655
      • Onkologie Westerstede
  • Baviera
    • Kempten, Baviera, Germany, 87439
      • Klinikum Kempten
  • Düsseldorf
    • Solingen, Düsseldorf, Germany, 42653
      • Städtisches Klinikum
  • Hesse
    • Darmstadt, Hesse, Germany, 64283
      • Klinikum Darmstadt Frauenklinik
    • Wetzlar, Hesse, Germany, 35578
      • BrustZentrum
  • Homburg
    • Homburg/Saar, Homburg, Germany, 66424
      • Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
  • Sajonia
    • Dresden, Sajonia, Germany, 1307
      • Onkologische Schwerpunktpraxis
    • Georgsmarienhutte, Sajonia, Germany, 49124
      • Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie
• Italy
  • Asti, Italy, 14100
    • Ospedale Cardinal Massaia
  • Bari, Italy, 70124
    • Istituto Tumori Giovanni Paolo II IRCCS
  • Benevento, Italy, 82100
    • Azienda Ospedaliera Gaetano Rummo
  • Bergamo, Italy, 24127
    • A. O. Papa Giovanni XXIII
  • Como, Italy, 22020
    • Ospedale S. Anna
  • Firenze, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Milano, Italy, 20157
    • A.O. Sacco
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori IRCCS Pascale
  • Parma, Italy, 43126
    • A.O.U. di Parma
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli Università Cattolica di Roma
  • Torino, Italy, 10153
    • Ospedale Gradenigo
  • Treviso, Italy, 31100
    • Ospedale Ca Foncello
  • Cerdeña
    • Monserrato, Cerdeña, Italy, 09042
      • Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • IRCCS Casa Sollievo della Sofferenza
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro Riferimento Oncologico di Aviano
  • Savona
    • Bergamo, Savona, Italy, 24047
      • Ospedale S.Maria d. Misericordia
• Spain
  • Barcelona, Spain, 08026
    • Hospital Sant Pau
  • Barcelona, Spain, 43204
    • Hospital de Reus
  • La Coruña, Spain, 15006
    • Complejo Hospitalario de la Coruña
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28033
    • MD Anderson
  • Murcia, Spain, 30120
    • Hospital Virgen de la Arrixaca
  • Palma de Mallorca, Spain, 07198
    • Hospital Son Llatzer
  • Sevilla, Spain, 41071
    • Hospital Virgen Macarena
  • Valencia, Spain, 46009
    • Instituto Valenciano de Oncologia
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
  • Jaen
    • Jaén, Jaen, Spain, 23007
      • Complejo Hospitalario de Jaén
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
      • Hospital Doctor Negrín
  • León
    • Leon, León, Spain, 28040
      • Hospital de Leon
  • Madrid
    • Parla, Madrid, Spain, 06080
      • Hospital Infanta Cristina
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36204
      • Hospital Xeral-Cies de Vigo
  • Santa Cruz De Tenerife
    • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Hospital Universitario de La Laguna
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto
    • Galdakao, Vizcaya, Spain, 48960
      • Hospital de Galdakao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Tumor Response	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	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	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	From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival	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.	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival by Prior Antiangiogenic Treatment	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.	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival by BRCA1/2 Status	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.	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival by Platinum Sensitivity	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.	From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Change From Baseline to Best Post-baseline ECOG Performance Status Score	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	Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
Change From Baseline to Best Post-baseline ECOG Performance Status Score by Prior Antiangiogenic Treatment	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	Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)

Collaborators and Investigators

• Sponsor: PharmaMar
• Investigators: Study Chair: María José Pontes, PharmaMar

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2015
• Primary Completion (Actual): September 18, 2019
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Trabectedin
• Other Study ID Numbers: ET-D-031-14