A phase III randomized controlled trial in primary stage three and four ovarian cancer after interval cytoreductive surgery (FOCUS/KOV-HIPEC-04)

초록

Introduction The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery increases progression-free and overall survival for patients with advanced-stage epithelial 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 advanced ovarian cancer in the era of maintenance therapy of bevacizumab and/or PARP inhibitor. Methods The KOV-HIPEC-04 is a multicenter, 1:1 randomized, phase III trial that will enroll 520 patients with primary epithelial ovarian cancer who completed neoadjuvant chemotherapy. Patients will be randomized at the time of interval cytoreductive surgery with achieving complete cytoreduction or cytoreduction with no more than 2.5 mm depth of residual disease to receive HIPEC (experimental arm, 41.0–42.0°C cisplatin 75 mg/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 endpoint is to evaluate overall survival (OS); secondary objectives are progression-free survival (PFS), cancer-specific survival, time to first subsequent therapy, safety, 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. ClinicalTrials.gov (NCT05827523) Current Trial Status Not yet Recruiting