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Completed

NCT Number: NCT02394015

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

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.

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Key information

Conditions

Ovarian Epithelial Cancer Recurrent

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Trabectedin and Pegylated Liposomal Doxorubicin

Drug

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

Primary outcomes

  1. 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).

  2. 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 ) .

Secondary outcomes

  1. Response rate to previous and post-treatment (Percentage of responses (CR+PR)

    Time frame: Up to 12 months

    Percentage of responses (CR+PR) at pretreatment and post-treatment

  2. Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)

    Time frame: Up to 12 months

    Percentage of responses ( CR + PR ) to trabectedin - DLP

  3. Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)

    Time frame: Up to 12 months

    Percentage of clinical benefit (CR + PR + SD for at least 4 months)

  4. Impact of trabectedin - PLD combination in subsequent treatments

    Time frame: Up to 12 months

    Assessment of the impact of treatment with trabectedin - PLD combination at the beginning of subsequent treatments

  5. Toxicity (adverse events)

    Time frame: Up to 12 months

    type , incidence , severity, frequency, severity and relationship to the treatment of adverse events reported in patients reports

  6. Comparison between PFS and PFS2

    Time frame: Up to 12 months

    Comparison of the PFS of prior platinum combination TRB + DLP and subsequent platinum PFS.

  7. Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)

    Time frame: Up to 12 months

    Number and Management of hypersensitivity reactions or allergies.

Sponsors and collaborators

Lead sponsor

Grupo Español de Investigación en Cáncer de Ovario

Other

Collaborators

  • PharmaMar

Registry information

Official study 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

Acronym: RETRO-ROC

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2015
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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