An observational study in Ovarian Cancer, sponsored by Grupo Español de Investigación en Cáncer de Ovario. Completed at 1 site in Spain. Open to female participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.
Sponsored by Grupo Español de Investigación en Cáncer de Ovario · Observational
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 43 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Grupo Español de Investigación en Cáncer de Ovario is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult women (≥ 70 years) diagnosed with platinum-sensitive relapsed ovarian cancer.
Exclusion Criteria:
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.
Serious and non-serious adverse events
Safety profile
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 8 months
Overall survival (OS)
Number of months since first trabectedin + PLD dose date until death due to any cause
Time frame: 8 months
Trabectedin + PLD treatment information (for both drugs)
Starting dose, total dose
Time frame: 8 months
Previous and subsequent treatments to trabectedin + PLD
Number of previous/subsequent treatments
Time frame: 8 months
Patient characteristics and medical history
Platinum-free interval (PFI)
Time frame: 8 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Grupo Español de Investigación en Cáncer de Ovario