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Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance (SOCCER-P)

Primary Purpose

Ovarian Cancer, Drug Related Neoplasm/Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
secondary cytoreductive surgery
chemotherapy
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage. Progression-free interval of at least 6 months after end of last platinum- containing therapy, Progressed during PARP inhibitor maintenance Women aged ≥ 18 years Complete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned A positive AGO-score or iMODEL+PET/CT Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative. Patients who have given their signed and written informed consent and their consent to data transmission and -processing. Exclusion Criteria: Patients with non-epithelial tumors as well as borderline tumors. Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy More than one prior chemotherapy Patients who are ineligible for pegylated liposomal doxorubicin or carboplatin Patients with second, third, or later recurrence Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum- containing therapy Only palliative surgery planned Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible) Any concomitant disease not allowing surgery and/or chemotherapy Any medical history indicating excessive peri-operative risk Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab) No assessable archival tumor tissue

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    secondary cytoreductive surgery followed by chemotherapy

    chemotherapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    progression-free survival
    interval between date of randomization and the date of second relapse/progression or death, whatever occurs first

    Secondary Outcome Measures

    Overall survival
    from date of randomisation until death

    Full Information

    First Posted
    January 19, 2023
    Last Updated
    March 7, 2023
    Sponsor
    Korea University Guro Hospital
    Collaborators
    Boryung Pharmaceutical Co., Ltd, Chong Kun Dang Pharmaceutical Corp., Yonsei University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05704621
    Brief Title
    Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
    Acronym
    SOCCER-P
    Official Title
    A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2026 (Anticipated)
    Study Completion Date
    February 28, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Guro Hospital
    Collaborators
    Boryung Pharmaceutical Co., Ltd, Chong Kun Dang Pharmaceutical Corp., Yonsei University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.
    Detailed Description
    The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer, Drug Related Neoplasm/Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    secondary cytoreductive surgery followed by chemotherapy
    Arm Type
    Experimental
    Arm Title
    chemotherapy
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    secondary cytoreductive surgery
    Intervention Description
    Maximum effort cytoreductive surgery
    Intervention Type
    Drug
    Intervention Name(s)
    chemotherapy
    Intervention Description
    six cycles of bevacizumab [10 mg/kg, days 1 and 15] plus carboplatin [AUC 5, day 1] plus pegylated liposomal doxorubicin [30 mg/m2, day 1] every 4 weeks, followed by maintenance bevacizumab [15 mg/kg every 3 weeks]
    Primary Outcome Measure Information:
    Title
    progression-free survival
    Description
    interval between date of randomization and the date of second relapse/progression or death, whatever occurs first
    Time Frame
    Up to 2 year
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Description
    from date of randomisation until death
    Time Frame
    Up to 2 year
    Other Pre-specified Outcome Measures:
    Title
    30-day post-operative complications
    Description
    MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications
    Time Frame
    From the operation until after 30 days
    Title
    Time to first subsequent anticancer therapy
    Description
    From date of randomization until the date of first recurrent anticancer therapy
    Time Frame
    Up to 1 year
    Title
    Time to second subsequent anticancer therapy
    Description
    From date of randomization until the date of secondary recurrent anticancer therapy
    Time Frame
    Up to 2 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage. Progression-free interval of at least 6 months after end of last platinum- containing therapy, Progressed during PARP inhibitor maintenance Women aged ≥ 18 years Complete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for isolated extra-abdominal recurrences are planned A positive AGO-score or iMODEL+PET/CT Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative. Patients who have given their signed and written informed consent and their consent to data transmission and -processing. Exclusion Criteria: Patients with non-epithelial tumors as well as borderline tumors. Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy More than one prior chemotherapy Patients who are ineligible for pegylated liposomal doxorubicin or carboplatin Patients with second, third, or later recurrence Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum- containing therapy Only palliative surgery planned Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible) Any concomitant disease not allowing surgery and/or chemotherapy Any medical history indicating excessive peri-operative risk Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab) No assessable archival tumor tissue
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyun-Woong Cho, MD. PhD.
    Phone
    82-2-2626-3228
    Email
    limpcho82@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hyun-Woong Cho, MD. PhD.
    Organizational Affiliation
    Korea University Guro Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

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