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NCT Number: NCT05868889

Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD

The median age at which ovarian cancer is diagnosed is 63 years (50-75). This is still a significant adverse factor for survival results. Seventy years can be considered the lower limit for the elderly term, since most of age-related changes occur later. Because of this, this group of patients is often not included in clinical trials and sometimes they do not receive adequate treatment. Little information is available on chemotherapy treatments in elderly patients. Data on the use of first-line chemotherapy in this population have recently been published. Trabectedin in combination with PLD is indicated for platinum-sensitive relapsed ovarian cancer and is an option for those patients in whom platinum is not the best option. There are some studies with trabectedin in combination with PLD in which some patients with this profile have been included, although not exclusively. Therefore, it is of interest to study the safety and efficacy profile of this treatment in elderly patients. With this information we will be able to know its real use in routine clinical practice at the national level in Spain in this population for which not much information is available. Safety and efficacy data (e.g. PFS, ORR, OS) will be collected retrospectively in order to draw conclusions about the combination of trabectedin + PLD, as a treatment option in this patient profile.

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Key information

Conditions

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

70 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients) or absence of consent sheet must be signed by the investigator. Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain.
  • Adult women (≥70 years at the time of treatment initiation with trabectedin and PLD).
  • Histological diagnosis of platinum-sensitive relapsed ovarian cancer (PFI ≥ 6 months).
  • Treatment started with trabectedin and PLD (at least one cycle) as standard of care between January 1st 2015 and December 31st 2019.
  • Patients must have received at least one cycle of trabectedin + PLD.

Exclusion criteria

  • Patients without medical record available (lost, empty or unretrievable clinical information).
  • Patients who explicitly refuse to participate in the study.

Treatment and study plan

Trabectedin and PLD

Drug

The main treatment observed in this study is trabectedin in combination with PLD in elderly patients with platinum-sensitive relapsed ovarian cancer, according to the SmPC.

Primary outcomes

  1. Serious and non-serious adverse events

    Time frame: 8 months

    Safety profile

  2. Progression-free survival (PFS)

    Time frame: 8 months

    Time in months since first trabectedin + PLD dose date until radiological progression (or death due to any cause) according to RECIST 1.1 criteria

  3. Overall response rate (ORR)

    Time frame: 8 months

    Number of patients having a best overall response (BOR) of complete response (CR) or partial response (PR), divided by the total number of response-evaluable patients (according to RECIST 1.1 criteria)

  4. Disease control rate (DCR)

    Time frame: 8 months

    Percentage of patients having a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria

  5. Overall survival (OS)

    Time frame: 8 months

    Number of months since first trabectedin + PLD dose date until death due to any cause

  6. Trabectedin + PLD treatment information (for both drugs)

    Time frame: 8 months

    Starting dose, total dose

  7. Previous and subsequent treatments to trabectedin + PLD

    Time frame: 8 months

    Number of previous/subsequent treatments

  8. Patient characteristics and medical history

    Time frame: 8 months

    Platinum-free interval (PFI)

Sponsors and collaborators

Lead sponsor

Grupo Español de Investigación en Cáncer de Ovario

Other

Registry information

Official study title

Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD According to SmPC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 22, 2023
Registry last updated
May 24, 2023

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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