796TiP - Rationale and study design of the KOV-HIPEC-04: A phase III randomized controlled trial in primary stage three and four ovarian cancer after interval cytoreductive surgery (FOCUS)

Background

The addition of hyperthermic intraperitoneal chemotherapy (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 survival benefit of HIPEC in stage III and IV ovarian cancer amidst maintenance therapy with bevacizumab or poly (ADP-ribose) polymerase (PARP) inhibitors.

Trial design

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 bevacizumab or PARP inhibitors. 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 elimination rate constant K (KELIM) score, 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 May 06, 2024, 144 (28.0%) patients are randomized.

Clinical trial identification

NCT05827523.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.