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 (RETRO-ROC)

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Epithelial Cancer Recurrent
• Intervention / Treatment: Drug: Trabectedin and Pegylated Liposomal Doxorubicin

• Study Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trabectedin+ PLD; Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC.	Drug: 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 from October 28, 2009 to October 31, 2014

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 ) .	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate to previous and post-treatment (Percentage of responses (CR+PR)	Percentage of responses (CR+PR) at pretreatment and post-treatment	Up to 12 months
Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)	Percentage of responses ( CR + PR ) to trabectedin - DLP	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)	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	Up to 12 months
Toxicity (adverse events)	type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports	Up to 12 months
Comparison between PFS and PFS2	Comparison of the PFS of prior platinum combination TRB + DLP and subsequent platinum PFS.	Up to 12 months
Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)	Number and Management of hypersensitivity reactions or allergies.	Up to 12 months

Collaborators and Investigators

• Sponsor: Grupo Español de Investigación en Cáncer de Ovario
• Collaborators: PharmaMar
• Investigators: Principal Investigator: Laura Vidal, MD, H. Clinic, Barcelona; Principal Investigator: Jose M Del Campo, MD, H. Vall d'Hebron, Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Platinum-sensitive Recurrent Ovarian Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Disease Attributes; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Hypersensitivity; Recurrence; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin; Trabectedin
• Other Study ID Numbers: GEICO 1402R; GEI-TRAB-2014-01 (Other Identifier: AEMPS)