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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)

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ClinicalTrials.gov Identifier: NCT02394015
Recruitment Status : Unknown
Verified August 2016 by Grupo Español de Investigación en Cáncer de Ovario.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ovarian Epithelial Cancer Recurrent Drug: Trabectedin and Pegylated Liposomal Doxorubicin

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Study Type : Observational
Estimated Enrollment : 80 participants
Time Perspective: Retrospective
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
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394015


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

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Responsible Party: Grupo Español de Investigación en Cáncer de Ovario
ClinicalTrials.gov Identifier: NCT02394015     History of Changes
Other Study ID Numbers: GEICO 1402R
GEI-TRAB-2014-01 ( Other Identifier: AEMPS )
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Grupo Español de Investigación en Cáncer de Ovario:
Platinum-sensitive Recurrent Ovarian Cancer
Additional relevant MeSH terms:
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Doxorubicin
Liposomal doxorubicin
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Trabectedin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents