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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02394015

Acronym

RETRO-ROC

Enrollment

Registered

2015-03-20

Start date

2013-05-06

Completion date

2017-12-31

Last updated

2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Epithelial Cancer Recurrent

Keywords

Platinum-sensitive Recurrent Ovarian Cancer

Brief 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.

Interventions

DRUGTrabectedin and Pegylated Liposomal Doxorubicin

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 design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Patients with records unavailable (lost, empty or not recoverable).

Design outcomes

Primary

Measure	Time frame	Description
Efficacy progression-free survival (PFS)	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)	Up to 12 months	Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of overall survival (OS ) .

Secondary

Measure	Time frame	Description
Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)	Up to 12 months	Percentage of clinical benefit (CR + PR + SD for at least 4 months)
Impact of trabectedin - PLD combination in subsequent treatments	Up to 12 months	Assessment of the impact of treatment with trabectedin - PLD combination at the beginning of subsequent treatments
Response rate to previous and post-treatment (Percentage of responses (CR+PR)	Up to 12 months	Percentage of responses (CR+PR) at pretreatment and post-treatment
Comparison between PFS and PFS2	Up to 12 months	Comparison of the PFS of prior platinum combination TRB + DLP and subsequent platinum PFS.
Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)	Up to 12 months	Number and Management of hypersensitivity reactions or allergies.
Toxicity (adverse events)	Up to 12 months	type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports
Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)	Up to 12 months	Percentage of responses ( CR + PR ) to trabectedin - DLP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026