Relapsed Ovarian CancerNIMES-ROCNCT02825420
Non-interventional European Study of Trabectedin + PLD in the Treatment of Relapsed Ovarian Cancer (ROC) Patients
An observational study of Relapsed Ovarian Cancer, run by PharmaMar at 65 sites in 5 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Relapsed Ovarian Cancer
- What is being tested?
- trabectedin
- How many people
- 220 participants
- Where
- 65 sitesin 5 countries
- Study dates
- 28 Jul 2015to 18 Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
65 sites in 5 countries.
65 sites in 5 countries
Spain19 sites
Complejo Hospitalario de La Coruña
A Coruña, 15006
Hospital Sant Pau
Barcelona, 08026
Hospital de Reus
Barcelona, 43204
Hospital de Basurto
Bilbao, Vizcaya, 48013
Hospital de Galdakao
Galdakao, Vizcaya, 48960
Complejo Hospitalario de Jaén
Jaén, Jaen, 23007
Hospital Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010
Hospital de León
León, León, 28040
MD Anderson
Madrid, 28033
Hospital Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Virgen de la Arrixaca
Murcia, 30120
Hospital Son Llatzer
Palma de Mallorca, 07198
Hospital Infanta Cristina
Parla, Madrid, 06080
Hospital Universitario de La Laguna
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Hospital Virgen Macarena
Seville, 41071
Instituto Valenciano de Oncología
Valencia, 46009
Hospital Xeral-Cíes de Vigo
Vigo, Pontevedra, 36204
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Italy16 sites
Ospedale Cardinal Massaia
Asti, 14100
Centro Riferimento Oncologico di Aviano
Aviano, Pordenone, 33081
Istituto Tumori Giovanni Paolo II IRCCS
Bari, 70124
Azienda Ospedaliera Gaetano Rummo
Benevento, 82100
Ospedale S.Maria d. Misericordia
Bergamo, Savona, 24047
A. O. Papa Giovanni XXIII
Bergamo, 24127
Ospedale S. Anna
Como, 22020
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
A.O. Sacco
Milan, 20157
Policlinico Universitario Monserrato - Presidio Policlinico Duilio Casula
Monserrato, Sardinia, 09042
Istituto Nazionale Tumori IRCCS Pascale
Naples, 80131
A.O.U. di Parma
Parma, 43126
Policlinico Universitario Agostino Gemelli Università Cattolica di Roma
Roma, 00168
IRCCS Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Foggia, 71013
Ospedale Gradenigo
Torino, 10153
Ospedale Cà Foncello
Treviso, 31100
Germany15 sites
Klinikum St. Marien Amberg
Amberg, 92224
Klinikum Arnsberg, Karolinen Hospital, Frauenheilkunde
Arnsberg, 59759
Onkologische Gemeinschaftspraxis
Bottrop, 46236
Klinikum Darmstadt Frauenklinik
Darmstadt, Hesse, 64283
Städt. Klinik Dortmund, Frauenklinik
Dortmund, 44137
Onkologische Schwerpunktpraxis
Dresden, Saxony, 1307
Franziskus-Hospital Harderberg Internistische Onkologie und Hämatologie
Georgsmarienhutte, Saxony, 49124
Uniklinik Homburg - Klinik Für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Homburg/Saar, Homburg, 66424
Klinikum Kempten
Kempten (Allgäu), Bavaria, 87439
Instirtut für klinische Forschung (IKF) Städtisches Klinikum München GmbH
München, 80804
Praxis Dr. Rene Schubert
Scheibenberg, 09481
Städtisches Klinikum
Solingen, Düsseldorf, 42653
Kreiskrankenhaus Torgau
Torgau, 04860
Onkologie Westerstede
Westerstede, Ammerland, 26655
Brustzentrum
Wetzlar, Hesse, 35578
France9 sites
Clinique de l'Europe
Amiens, 80000
Medipole de Savoie
Challes-les-Eaux, 73190
Centre d'Oncologie et de Radiothérapie du Parc
Dijon, Borgoña, 21000
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, Sharte, 72000
Institut d'Oncologie Hauts-de-Seine Nord
Neuilly-sur-Seine, Seine
Oncologie médicale du Val d'Oise
Osny, 95520
Hôpital Saint Louis
Paris, 75010
Strasbourg Oncologie Libérale Centre de radiothérapie
Strasbourg, 67000
Clinique Saint Jean
Toulon, Provence, 83000
Belgium6 sites
O.L.V. Aalst
Aalst, Flanders, 164-9300
CHIREC - Cancer Institute
Brussels, 32-1180
AZ Maria Middelares
Ghent, Flanders, 1026-9000
Centre Hospitalier de Jolimont
La Louvière, Henao, 7100
CHU Ambroise-Paré
Mons, Henao, 02-7000
Centre Hospitalier de Wallonie Picarde
Tournai, Henao, 807500
About this study
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
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
- Being tested
- trabectedin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabectedinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start28 Jul 2015
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- María José Pontes, Study chair, PharmaMar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825420
- Sponsor's protocol ID
- ET-D-031-14
- Acronym
- NIMES-ROC
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2016
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02825420
- Acronym / sponsor ID
- NIMES-ROC / ET-D-031-14
- Conditions
- Relapsed Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with platinum-sensitive relapsed ovarian cancer who are receiving trabectedin + PLD according to SmPC.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trabectedin | Drug | – |
Primary outcome
Progression-Free Survival
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
8 secondary outcomes
Best Tumor Response
Time frame: 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
Time frame: From Day 1 of study treatment to end of study, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival
Time frame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival by Prior Antiangiogenic Treatment
Time frame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival by BRCA1/2 Status
Time frame: From Day 1 to death, up to 4.5 years (Jan 2015 to Sept 2019)
Overall Survival by Platinum Sensitivity
Time frame: 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
Time frame: 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
Time frame: Through study completion, up to 4.5 years (Jan 2015 to Sept 2019)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María José Pontes study chair
PharmaMar
65 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Ovarian Cancer, run by PharmaMar at 65 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Spain, Italy, Germany, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.