Menu
Recruiting NCT05704621

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

Phase II Interventional Ovarian Cancer Drug Related Neoplasm/Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: secondary cytoreductive surgery, chemotherapy.
Who it may be relevant to
Registry conditions: Ovarian Cancer, Drug Related Neoplasm/Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure secondary cytoreductive surgery
    Maximum effort cytoreductive surgery
  • Drug chemotherapy
    six cycles of platinum-based chemotherapy +/- bevacizumab

Primary outcome measures

  • progression-free survival [Time frame: Up to 2 year]
Secondary outcome measures (1)
  • Overall survival [Time frame: Up to 2 year]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Severance Hospital — Seoul

Publications

  • Cho HW, Kim HS, Park JY, Lee YY, Lim MC, Lee SJ, Min KJ, Eoh KJ, Lee KB, Kim MK, Song JY, Shim SH, Ji YI, Song YJ, Chang SJ, Kim MK, Abe A, Kobayashi Y, Kajiyama H, Shimada M, Okamoto A, Ng JS, Lee JY. 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 PMID 39164041

Identifiers

NCT: NCT05704621 · KGOG3067/JGOG3036/APGOT-OV11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗