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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKorea University Guro Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • secondary cytoreductive surgery
  • chemotherapy

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Korea University Guro Hospital

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Collaborator

Chong Kun Dang Pharmaceutical Corp.

Collaborator

Yonsei University

Collaborator

KGOG: Korean Gynaelogical Onology Group, Korea

Collaborator

Japanese Gynecologic Oncology Group

Collaborator

Asia-Pacific Gynecologic Oncology Trials Group

Collaborator