Rationale and study design of the KOV-HIPEC-02R (RECOVER): A randomized, multicenter, open-label phase III trial of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer
Year: 2025
Type: article
Study design: Study Protocol
Abstract: TPS5628 Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) administered during interval cytoreductive surgery following neoadjuvant chemotherapy has shown to increase progression-free survival (PFS) and overall survival (OS) rates, as indicated by the OV-HIPEC-01 and KOV-HIPEC-01 trials. A recent meta-analysis (Kim SI, Kim JH, et al., GO 2023) demonstrated a survival benefit associated with HIPEC, particularly after recent exposure of chemotherapy. Moreover, in ovarian cancer, HIPEC is suggested to be effective in overcoming chemotherapy resistance. Methods: This trial (KOV-02R, RECOVER) is a multicenter, open-label, 1:1 randomized, phase III trial that will enroll 140 patients with platinum-resistant recurrent epithelial ovarian cancer (NCT05316181). After cytoreductive surgery, patients undergo the HIPEC procedure at 41.5°C, with doxorubicin at 35mg/ m 2 and mitomycin at 15mg/m 2 . Enrolled patients receive non-platinum compound systemic chemotherapy until disease progression. The primary objective is to evaluate progression-free survival between the HIPEC group and the control group. Secondary objectives include overall survival, cancer-specific survival, and safety and quality of life. Considering a 5-year enrollment period, 2-year follow-up, and a statistical power of 80%, 140 patients are needed, accounting for a 10% dropout rate. As of January 10, 2025, 115 patients (82.1%) have been randomized. Clinical trial information: NCT05316181 .
Source: Gynecologic Oncology
Institutions: National Cancer Center, Ewha Womans University, Ewha Womans University Medical Center, Korea University Guro Hospital, Korea University, Korea University Medical Center, Inje University Busan Paik Hospital, Samsung Medical Center, Asan Medical Center, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul National University, SNUH SMG-SNU Boramae Medical Center, Pusan National University Yangsan Hospital, Pusan National University Hospital
Language: English
Subfield: Reproductive Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4410815210