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

Ovarian Epithelial Cancer Recurrent Clinical Trial

— RETRO-ROC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394015
• Other study ID #: GEICO 1402R
• Secondary ID: GEI-TRAB-2014-01
• Status: Completed
• Start date: May 6, 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2020
• Source: Grupo Español de Investigación en Cáncer de Ovario
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Hypersensitivity
• Ovarian Epithelial Cancer Recurrent
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Español de Investigación en Cáncer de Ovario	PharmaMar

Outcome

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