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

March 3, 2025 updated by: Hyun Woong Cho, Korea University Guro Hospital

A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
        • Contact:
          • Jung-Yun Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

    1. A positive AGO-score or iMODEL+PET/CT
    2. 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: secondary cytoreductive surgery followed by chemotherapy
surgery arm
Procedure: secondary cytoreductive surgery
Maximum effort cytoreductive surgery
Other Names:
  • secondary cytoreductive surgery followed by chemotherapy
Drug: chemotherapy
six cycles of platinum-based chemotherapy +/- bevacizumab
Other Names:
  • no surgery and only chemotherapy
Active Comparator: chemotherapy
no surgery arm
Drug: chemotherapy
six cycles of platinum-based chemotherapy +/- bevacizumab
Other Names:
  • no surgery and only chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: Up to 2 year
interval between date of randomization and the date of second relapse/progression or death, whatever occurs first
Up to 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 2 year
from date of randomisation until death
Up to 2 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day post-operative complications
Time Frame: From the operation until after 30 days
MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications
From the operation until after 30 days
Time to first subsequent anticancer therapy
Time Frame: Up to 1 year
From date of randomization until the date of first recurrent anticancer therapy
Up to 1 year
Time to second subsequent anticancer therapy
Time Frame: Up to 2 year
From date of randomization until the date of secondary recurrent anticancer therapy
Up to 2 year
Quality of life
Time Frame: baseline, 6 month and 1year after randomization
EORTC QLQ-C30,OV28, and EQ-5D-5L
baseline, 6 month and 1year after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Yonsei University
Boryung Pharmaceutical Co., Ltd
Japanese Gynecologic Oncology Group (JGOG)
Chong Kun Dang Pharmaceutical Corp.
Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
KGOG: Korean Gynaelogical Onology Group, Korea

Investigators

  • Principal Investigator: Hyun-Woong Cho, MD. PhD., Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 28, 2026

Study Completion (Estimated)

December 28, 2028

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG3067/JGOG3036/APGOT-OV11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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