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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05868889
• Other study ID #: GEICO 105-O
• Status: Completed
• Start date: October 21, 2021
• Est. completion date: June 16, 2022

Study information

• Verified date: May 2023
• Source: Grupo Español de Investigación en Cáncer de Ovario
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 16, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Investigación en Cáncer de Ovario

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious and non-serious adverse events	Safety profile	8 months
Primary	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
Primary	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
Primary	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
Primary	Overall survival (OS)	Number of months since first trabectedin + PLD dose date until death due to any cause	8 months
Primary	Trabectedin + PLD treatment information (for both drugs)	Starting dose, total dose	8 months
Primary	Previous and subsequent treatments to trabectedin + PLD	Number of previous/subsequent treatments	8 months
Primary	Patient characteristics and medical history	Platinum-free interval (PFI)	8 months