253 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)

Introduction/Background

The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery increases progression-free and overall survival for patients with stage III ovarian cancer in two randomized controlled trials (OV-HIPEC-01 and KOV-HIPEC-01). The aim of this trial is to identify the survival benefit of HIPEC in stage III & IV ovarian cancer in the era of maintenance therapy of bevacizumab and/or PARP inhibitor.

Methodology

Ovarian cancer patients will be randomized at the time of interval cytoreductive surgery with achieving complete cytoreduction or cytoreduction with no more than 2.5mm size of residual disease 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. 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.

Results

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Conclusion

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Disclosures

MCL reported having a consulting or advisory role for AstraZeneca, Boryung, CKD Pharm, Genexine, Hospicare, GI Innovation, and Takeda and receiving research funding from AbbVie, Amgen, Astellas, AstraZeneca, BeiGene, Cellid, CKD Pharm, Clovis, Eisai, Genexine, GSK, Incyte, Merck, MSD, OncoQuest, Pfizer, and Roche outside the submitted work.