Article Text
Abstract
Introduction The addition of HIPEC during interval cytoreductive surgery improves PFS and OS in stage III ovarian cancer (OV-01 and KOV-01 trials). This trial aims to assess HIPEC’s survival benefit in stage III & IV ovarian cancer amidst maintenance therapy with bevacizumab and/or PARP inhibitors.
Methods The trial is registered on ClinialTrials.gov (NCT05827523). Ovarian cancer patients will be randomized at the time of interval cytoreductive surgery with residual disease < 2.5mm to receive HIPEC (41.5 cisplatin 75mg/m2, 90 minutes) or not (control arm). After recovery from surgery, patients will receive postoperative platinum-based adjuvant chemotherapy followed by maintenance therapy with PARP inhibitor or bevacizumab. The primary objective of the trial is to evaluate OS in two groups. Secondary objectives are PFS, cancer-specific survival, time to first subsequent therapy (TFST), safety, CA-125 KELIM, and quality of life. Assuming that the enrollment period is 5 years and the follow-up period is 3 years, the total number of events required is 263. Based on the log-rank test, the total number of subjects required to prove HR 0.67 with a two-sided alpha of 0.05 and 90% power is 494. 520 patients are finally studied, considering 5% drop-out. Until April 2024, 143 (28.0%) patients are randomized.
Results There are no available results at the time of submission.
Conclusion/Implications The role of HIPEC during interval cytoreductive surgery will be discovered in stage III & IV ovarian cancer with this randomized trial (KOV-04) for the first time.