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

Relapsed Ovarian Cancer Clinical Trial

— NIMES-ROC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825420
• Other study ID #: ET-D-031-14
• Status: Completed
• Start date: July 28, 2015
• Est. completion date: September 18, 2019

Study information

• Verified date: July 2021
• Source: PharmaMar
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Relapsed Ovarian Cancer

Intervention

Drug:
• trabectedin

Locations

Country	Name	City	State
Belgium	O.L.V. Aalst	Aalst	Flandes
Belgium	CHIREC - Cancer Institute	Bruxelles
Belgium	AZ Maria Middelares	Gent	Flandes
Belgium	Centre Hospitalier de Jolimont	La Louviere	Henao
Belgium	CHU Ambroise-Paré	Mons	Henao
Belgium	Centre Hospitalier de Wallonie Picarde	Tournai	Henao
France	Clinique de l'Europe	Amiens
France	Medipole de Savoie	Challes Les Eaux
France	Centre d'Oncologie et de Radiothérapie du Parc	Dijon	Borgoña
France	Clinique Victor Hugo - Centre Jean Bernard	Le Mans	Sharte
France	Institut d'Oncologie Hauts-de-Seine Nord	Neuilly sur Seine	Seine
France	Oncologie médicale du Val d'Oise	Osny
France	Hôpital Saint Louis	Paris
France	Strasbourg Oncologie Libérale Centre de radiothérapie	Strasbourg
France	Clinique Saint Jean	Toulon	Provence
Germany	Klinikum St. Marien Amberg	Amberg
Germany	Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde	Arnsberg
Germany	Onkologische Gemeinschaftspraxis	Bottrop
Germany	Klinikum Darmstadt Frauenklinik	Darmstadt	Hesse
Germany	Städt. Klinik Dortmund, Frauenklinik	Dortmund
Germany	Onkologische Schwerpunktpraxis	Dresden	Sajonia
Germany	Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie	Georgsmarienhutte	Sajonia
Germany	Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin	Homburg/Saar	Homburg
Germany	Klinikum Kempten	Kempten	Baviera
Germany	Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH	München
Germany	Praxis Dr. Rene Schubert	Scheibenberg
Germany	Städtisches Klinikum	Solingen	Düsseldorf
Germany	Kreiskrankenhaus Torgau	Torgau
Germany	Onkologie Westerstede	Westerstede	Ammerland
Germany	Brustzentrum	Wetzlar	Hesse
Italy	Ospedale Cardinal Massaia	Asti
Italy	Centro Riferimento Oncologico di Aviano	Aviano	Pordenone
Italy	Istituto Tumori Giovanni Paolo II IRCCS	Bari
Italy	Azienda Ospedaliera Gaetano Rummo	Benevento
Italy	A. O. Papa Giovanni XXIII	Bergamo
Italy	Ospedale S.Maria d. Misericordia	Bergamo	Savona
Italy	Ospedale S. Anna	Como
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	A.O. Sacco	Milano
Italy	Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula	Monserrato	Cerdeña
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	IRCCS Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Foggia
Italy	Ospedale Gradenigo	Torino
Italy	Ospedale Cà Foncello	Treviso
Spain	Hospital de Reus	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital de Galdakao	Galdakao	Vizcaya
Spain	Complejo Hospitalario de Jaén	Jaén	Jaen
Spain	Complejo Hospitalario de La Coruña	La Coruña
Spain	Hospital Doctor Negrín	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital de León	Leon	León
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	MD Anderson	Madrid
Spain	Hospital Virgen de la Arrixaca	Murcia
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Hospital Infanta Cristina	Parla	Madrid
Spain	Hospital Universitario de La Laguna	San Cristóbal de La Laguna	Santa Cruz De Tenerife
Spain	Hospital Virgen Macarena	Sevilla
Spain	Instituto Valenciano de Oncología	Valencia
Spain	Hospital Xeral-Cíes de Vigo	Vigo	Pontevedra
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
PharmaMar

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)