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

NCT05868889 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2023-05-24

No results posted yet for this study

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

Interventions

DRUG

Trabectedin and PLD

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.

Sponsors & Collaborators

  • Grupo Español de Investigación en Cáncer de Ovario

    lead OTHER

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2022-06-10
Completion
2022-06-16
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868889 on ClinicalTrials.gov