Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868889
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2023-05-11
Brief Title:
Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD
Sponsor:
Grupo Español de Investigación en Cáncer de Ovario
Organization:
Grupo Español de Investigación en Cáncer de Ovario
Study Overview
Official Title:
Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD According to SmPC
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None