Ovarian CancerNCT05868889
Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD
An observational study of Ovarian Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Trabectedin and PLD
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 21 Oct 2021to 16 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Adult women (≥ 70 years) diagnosed with platinum-sensitive relapsed ovarian cancer.
Who may be able to join
- 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.
Who cannot join
- Patients without medical record available (lost, empty or unretrievable clinical information).
- Patients who explicitly refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD According to SmPC
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
- Being tested
- Trabectedin and PLD
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabectedin and PLDDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious and non-serious adverse events
Safety profile
Measured: 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
Measured: 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)
Measured: 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
Measured: 8 months
Overall survival (OS)
Number of months since first trabectedin + PLD dose date until death due to any cause
Measured: 8 months
Trabectedin + PLD treatment information (for both drugs)
Starting dose, total dose
Measured: 8 months
Previous and subsequent treatments to trabectedin + PLD
Number of previous/subsequent treatments
Measured: 8 months
Patient characteristics and medical history
Platinum-free interval (PFI)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start21 Oct 2021
- Primary completion10 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Investigación en Cáncer de Ovario
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868889
- Sponsor's protocol ID
- GEICO 105-O
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter Study of Elderly Patients With Ovarian Cancer Treated With Trabectedin and PLD According to SmPC
- ClinicalTrials.gov ID
- NCT05868889
- Acronym / sponsor ID
- GEICO 105-O
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Grupo Español de Investigación en Cáncer de OvarioUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adult women (≥ 70 years) diagnosed with platinum-sensitive relapsed ovarian cancer.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients without medical record available (lost, empty or unretrievable clinical information).
- Patients who explicitly refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabectedin and PLDThe 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. | Drug | – |
Primary outcome
Serious and non-serious adverse events
Time frame: 8 months
Safety profile
Progression-free survival (PFS)
Time frame: 8 months
Time in months since first trabectedin + PLD dose date until radiological progression (or death due to any cause) according to RECIST 1.1 criteria
Overall response rate (ORR)
Time frame: 8 months
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)
Disease control rate (DCR)
Time frame: 8 months
Percentage of patients having a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria
Overall survival (OS)
Time frame: 8 months
Number of months since first trabectedin + PLD dose date until death due to any cause
Trabectedin + PLD treatment information (for both drugs)
Time frame: 8 months
Starting dose, total dose
Previous and subsequent treatments to trabectedin + PLD
Time frame: 8 months
Number of previous/subsequent treatments
Patient characteristics and medical history
Time frame: 8 months
Platinum-free interval (PFI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious and non-serious adverse events (time frame: 8 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.