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

Completed

• Conditions: Ovarian Epithelial Cancer Recurrent
• Interventions: Drug: Trabectedin and Pegylated Liposomal Doxorubicin

• Registration Number: NCT02394015
• Lead Sponsor: Grupo Español de Investigación en Cáncer de Ovario

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-06
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trabectedin+ PLD	Trabectedin 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)	Up to 12 months	Number and Management of hypersensitivity reactions or allergies.
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.
Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)	Up to 12 months	Percentage of responses ( CR + PR ) to trabectedin - DLP
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
Toxicity (adverse events)	Up to 12 months	type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports