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Completed

NCT Number: NCT02825420

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

O.L.V. Aalst, Aalst, Flanders, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trabectedin

Drug

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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)

    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

  2. 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)

    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

  3. Overall Survival

    Time frame: 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.

  4. 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 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.

  5. 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 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.

  6. Overall Survival by Platinum Sensitivity

    Time frame: 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.

  7. 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)

    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

  8. 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)

    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

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study 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

Acronym: NIMES-ROC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2016
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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