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

NCT05704621RecruitingPHASE2INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Korea University Guro Hospital

Enrollment

124

Start Date

2023-12-01

Completion Date

2026-12-28

Study Type

INTERVENTIONAL

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

Interventions

secondary cytoreductive surgerychemotherapy

Conditions

Ovarian CancerDrug Related Neoplasm/Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

progression-free survival

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

Time frame: Up to 2 year

Secondary Outcomes

Overall survival

from date of randomisation until death

Time frame: Up to 2 year

Locations

Severance Hospital, Seoul, South Korea

Linked Papers

2024-11-04

A randomized phase II study of secondary cytoreductive surgery in patients with relapsed ovarian cancer who have progressed on a PARP inhibitor as first-line maintenance therapy: the SOCCER-P study (KGOG 3067/JGOG 3036/APGOT-OV11)

Although two recent phase III randomized controlled trials showed survival benefits of undergoing secondary cytoreductive surgery for an initial relapse of ovarian cancer, patients who received a poly-ADP ribose polymerase inhibitor (PARPi) as the first-line maintenance treatment, which is currently the standard treatment for advanced ovarian cancer, were not included in those trials. Therefore, determining an optimal treatment strategy, including secondary cytoreductive surgery, in patients whose cancer progresses even with PARPi treatment, is needed. To determine whether secondary cytoreductive surgery is beneficial in patients who have progressed on PARPi maintenance treatment. Secondary cytoreductive surgery followed by chemotherapy is superior to chemotherapy alone for patients who have progressed on PARPi maintenance treatment. The SOCCER-P study is a multicenter randomized phase II clinical trial. Patients who meet the eligibility criteria will be randomized to either undergo secondary cytoreductive surgery and subsequent platinum-based chemotherapy plus or minus bevacizumab, or to receive platinum-based chemotherapy plus or minus bevacizumab alone. Patients randomly allocated to the surgery group will undergo secondary cytoreductive surgery followed by six cycles of a physician's choice of platinum-based chemotherapy once they have recovered from surgery. The major inclusion criteria are as follows: first recurrence of disease with treatment-free interval from last platinum dose (TFIp) ≥6 months and progression during PARPi maintenance or treatment-free interval from last PARPi therapy (TFI Progression-free survival. 124 patients. Accrual completion approximately the end of 2026 and the results are expected after 2 years of follow-up in 2029. NCT05704621.

Linked Investigators

Hee Seung Kim

Hiroaki Kajiyama

Hyun-Woong Cho

Jeong-Yeol Park

Joseph Soon-Yau Ng

Mi-Kyung Kim

Seung-Hyuk Shim

Suk-Joon Chang

Gynecologic Cancer Center Department of Obstetrics and Gynecology, Ajou University School of Medicine

Yoo-Young Lee

Yusuke Kobayashi