TP018/#822 A randomized, multicenter, open-label phase III trial of hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer

Introduction

Recent randomized trials (OV-HIPEC-01 and KOV-HIPEC-01) and meta-analyses reveal survival benefits of HIPEC after recent exposure of systemic chemotherapy exposure in ovarian cancer.

Methods

This trial (KOV-HIPEC-02) is a multicenter, open-label, 1:1 randomized, phase III trial that will enroll 140 patients in platinum-resistant recurrent epithelial ovarian cancer. The trial is registered on ClinicalTrials.gov (NCT05316181). The experimental arm will receive HIPEC (41.0–42.0°C, doxorubicin 35 mg/m² and mitomycin 15 mg/m², 90 min) followed by physician's choice chemotherapy, and the control arm will receive physician's choice chemotherapy without HIPEC until disease progression or unacceptable toxicities. The primary objective of the trial is to evaluate progression-free survival (PFS). Secondary objectives are overall survival (OS), cancer-specific survival, safety, and quality of life. Assuming that the enrollment period is 3 years and the follow-up period is 2 years, the total number of events required is 121. Based on the log-rank test, the total number of subjects required to prove HR 0.6 with a two-sided alpha 0.05 and 80% power is 126. 140 patients are finally studied considering 10% drop-out.

Current Trial Status

Active Recruiting