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Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Primary Purpose

Epithelial Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pegylated liposomal Doxorubicin (CAELYX) & Carboplatin
Paclitaxel & Carboplatin
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with epithelial Ovarian cancer in late relapse

Sites / Locations

    Outcomes

    Primary Outcome Measures

    overall survival

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2007
    Last Updated
    December 16, 2015
    Sponsor
    King Faisal Specialist Hospital & Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00538603
    Brief Title
    Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)
    Official Title
    Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Faisal Specialist Hospital & Research Center

    4. Oversight

    5. Study Description

    Brief Summary
    Multi-national, randomized, phase III, GCIG Intergroup study comparing pegylated liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in patients with epithelial ovarian cancer in late relapse. (CALYPSO)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epithelial Ovarian Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    pegylated liposomal Doxorubicin (CAELYX) & Carboplatin
    Intervention Description
    Chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel & Carboplatin
    Intervention Description
    Chemotherapy
    Primary Outcome Measure Information:
    Title
    overall survival
    Time Frame
    overall

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with epithelial Ovarian cancer in late relapse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Adnan Munkarah, MD
    Organizational Affiliation
    King Faisal Specialist Hospital & Research Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

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