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

NCT05868889 | Completed FDA Drug

• 1 other identifier: GEICO 105-O
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (8)

• Serious and non-serious adverse events

  Safety profile

  8 months

• Progression-free survival (PFS)

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

  8 months

• Overall response rate (ORR)

  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)

  8 months

• Disease control rate (DCR)

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

  8 months

• Overall survival (OS)

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

  8 months

• Trabectedin + PLD treatment information (for both drugs)

  Starting dose, total dose

  8 months

• Previous and subsequent treatments to trabectedin + PLD

  Number of previous/subsequent treatments

  8 months

• Patient characteristics and medical history

  Platinum-free interval (PFI)

  8 months

Interventions

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult women (≥ 70 years) diagnosed with platinum-sensitive relapsed ovarian cancer.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Grupo Español de Investigación en Cáncer de Ovario: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Trabectedin; 1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: October 21, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 16, 2022
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)