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.
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
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
Parallel
secondary cytoreductive surgery
Procedure/SurgeryMaximum effort cytoreductive surgery
chemotherapy
Drugsix cycles of platinum-based chemotherapy +/- bevacizumab
progression-free survival
interval between date of randomization and the date of second relapse/progression or death, whatever occurs first
Overall survival
from date of randomisation until death
30-day post-operative complications
MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications
Time to first subsequent anticancer therapy
From date of randomization until the date of first recurrent anticancer therapy
Time to second subsequent anticancer therapy
From date of randomization until the date of secondary recurrent anticancer therapy
Quality of life
EORTC QLQ-C30,OV28, and EQ-5D-5L
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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
