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NCT Number: NCT05704621

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.

Recruiting

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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
  • 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 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

Treatment and study plan

secondary cytoreductive surgery

Procedure

Maximum effort cytoreductive surgery

Other names: secondary cytoreductive surgery followed by chemotherapy

Chemotherapy

Drug

six cycles of platinum-based chemotherapy +/- bevacizumab

Other names: no surgery and only chemotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall survival

    Time frame: Up to 2 year

    from date of randomisation until death

Other outcomes

  1. 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

  2. Time to first subsequent anticancer therapy

    Time frame: Up to 1 year

    From date of randomization until the date of first recurrent anticancer therapy

  3. Time to second subsequent anticancer therapy

    Time frame: Up to 2 year

    From date of randomization until the date of secondary recurrent anticancer therapy

  4. Quality of life

    Time frame: baseline, 6 month and 1year after randomization

    EORTC QLQ-C30,OV28, and EQ-5D-5L

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun-Woong Cho, MD. PhD.

CONTACT

[email protected]

82-2-2626-3228

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SOCCER-P

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jan 30, 2023
Registry last updated
Mar 6, 2025

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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