Ovarian Epithelial Cancer RecurrentRETRO-ROCNCT02394015
Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC
An observational study of Ovarian Epithelial Cancer Recurrent, run by Grupo Español de Investigación en Cáncer de Ovario.
Trial summary
Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Epithelial Cancer Recurrent
- What is being tested?
- Trabectedin and Pegylated Liposomal Doxorubicin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2013to Dec 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have received treatment with trabectedin - DLP for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.
Who may be able to join
- Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.
Who cannot join
- Patients with records unavailable (lost, empty or not recoverable).
About this study
Official title: Multicenter and Retrospective Observational Study to Analyze the Efficacy and Safety of the Combination With Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to Data Sheet
Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.
- Conditions
- Ovarian Epithelial Cancer Recurrent
- Being tested
- Trabectedin and Pegylated Liposomal Doxorubicin
- Keywords
- Platinum-sensitive Recurrent Ovarian Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabectedin and Pegylated Liposomal DoxorubicinDrug
Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC from October 28, 2009 to October 31, 2014
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin+ PLD | Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC. Receives: Drug: Trabectedin and Pegylated Liposomal Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy progression-free survival (PFS)
Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of progression-free survival ( PFS).
Measured: Up to 12 months
Overall survival (OS)
Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of overall survival (OS ) .
Measured: Up to 12 months
Secondary outcomes (7)
Response rate to previous and post-treatment (Percentage of responses (CR+PR)
Percentage of responses (CR+PR) at pretreatment and post-treatment
Measured: Up to 12 months
Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)
Percentage of responses ( CR + PR ) to trabectedin - DLP
Measured: Up to 12 months
Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)
Percentage of clinical benefit (CR + PR + SD for at least 4 months)
Measured: Up to 12 months
Impact of trabectedin - PLD combination in subsequent treatments
Assessment of the impact of treatment with trabectedin - PLD combination at the beginning of subsequent treatments
Measured: Up to 12 months
Toxicity (adverse events)
type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports
Measured: Up to 12 months
Comparison between PFS and PFS2
Comparison of the PFS of prior platinum combination TRB + DLP and subsequent platinum PFS.
Measured: Up to 12 months
Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)
Number and Management of hypersensitivity reactions or allergies.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start6 May 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial Cancer RecurrentStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Investigación en Cáncer de Ovario
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Laura Vidal, MD, Principal investigator, H. Clinic, BarcelonaJose M Del Campo, MD, Principal investigator, H. Vall d'Hebron, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394015
- Sponsor's protocol ID
- GEICO 1402R
- Other IDs
- GEI-TRAB-2014-01
- Acronym
- RETRO-ROC
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2015
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter and Retrospective Observational Study to Analyze the Efficacy and Safety of the Combination With Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to Data Sheet
- ClinicalTrials.gov ID
- NCT02394015
- Acronym / sponsor ID
- RETRO-ROC / GEICO 1402R
- Conditions
- Ovarian Epithelial Cancer Recurrent
- Keywords
- Platinum-sensitive Recurrent Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Grupo Español de Investigación en Cáncer de OvarioUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- 6 May 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Mar 2015 (estimated)
- 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.
Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trabectedin+ PLD | – | Drug: Trabectedin and Pegylated Liposomal DoxorubicinTrabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have received treatment with trabectedin - DLP for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.
Key inclusion criteria (1 listed)
- Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.
Key exclusion criteria (1 listed)
- Patients with records unavailable (lost, empty or not recoverable).
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 Pegylated Liposomal DoxorubicinTrabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC from October 28, 2009 to October 31, 2014 | Drug | Trabectedin+ PLD |
Primary outcome
Efficacy progression-free survival (PFS)
Time frame: Up to 12 months
Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of progression-free survival ( PFS).
Overall survival (OS)
Time frame: Up to 12 months
Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of overall survival (OS ) .
7 secondary outcomes
Response rate to previous and post-treatment (Percentage of responses (CR+PR)
Time frame: Up to 12 months
Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)
Time frame: Up to 12 months
Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)
Time frame: Up to 12 months
Impact of trabectedin - PLD combination in subsequent treatments
Time frame: Up to 12 months
Toxicity (adverse events)
Time frame: Up to 12 months
Comparison between PFS and PFS2
Time frame: Up to 12 months
Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)
Time frame: Up to 12 months
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 27 Mar 2020.
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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.
Laura Vidal, MD principal investigator
H. Clinic, Barcelona
Jose M Del Campo, MD principal investigator
H. Vall d'Hebron, Barcelona
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Epithelial Cancer Recurrent, run by Grupo Español de Investigación en Cáncer de Ovario.
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 1 inclusion and 1 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 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Efficacy progression-free survival (PFS) (time frame: Up to 12 months). The study lists 2 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 27 Mar 2020.