A randomized, multicenter, open-label phase III trial of hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer (KOV-HIPEC-02).

person Myong Cheol Lim Gynecologic Oncology, National Cancer Center Korea, Goyang-Si, Gyeonggi-do, South Korea info_outline Myong Cheol Lim, Ji Hyun Kim, Eun Young Park, Dae Hoon Jeong, Yoo-Young Lee, Chel Hun Choi, Sungjong Lee, Shin-Wha Lee, Jeong-Yeol Park, Se Ik Kim, Jong Chul Baek, Hyeong In Ha, Yong Jung Song, Seob Jeon, Taek Sang Lee, Hye won Jeon, Ki Hyung Kim, Sang-Yoon Park

Authors person Myong Cheol Lim Gynecologic Oncology, National Cancer Center Korea, Goyang-Si, Gyeonggi-do, South Korea info_outline Myong Cheol Lim, Ji Hyun Kim, Eun Young Park, Dae Hoon Jeong, Yoo-Young Lee, Chel Hun Choi, Sungjong Lee, Shin-Wha Lee, Jeong-Yeol Park, Se Ik Kim, Jong Chul Baek, Hyeong In Ha, Yong Jung Song, Seob Jeon, Taek Sang Lee, Hye won Jeon, Ki Hyung Kim, Sang-Yoon Park Organizations Gynecologic Oncology, National Cancer Center Korea, Goyang-Si, Gyeonggi-do, South Korea, National Cancer Center Korea, Goyang, South Korea, National Cancer Center, Korea, Goyang, South Korea, Inje University Busan Paik Hospital, Busanjin-gu, Busan, Korea., Busan, South Korea, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan Un, Seoul, South Korea, Samsung Medical Center, Sungkyunkwan University, Gangnam-Gu, South Korea, Department of Obstetrics and Gynecology, Seoul St Mary’s Hospital, Seoul, South Korea, Asan Medical Center, Seoul, South Korea, Asan Medical Center, Songpa-Gu, South Korea, Seoul National University College of Medicine, Seoul, South Korea, Department of Obstetrics and Gynecology, Gyeongsang National University, Korea, Jin Ju, South Korea, Pusan National University Yangsan Hospital, Yangsan-Si, Gyeongsangnam-Do, South Korea, Department of Obstetrics and Gynecology, Pusan Yangsan National University Hospital, Pusan, South Korea, Department of Obstetrics and Gynecology, Soonchunhyang University Cheonan Hospital, Cheonan, South Korea, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, South Korea, Department of Obstetrics and Gynecology, Pusan National University Hospital, Pusan, South Korea, National Cancer Center, Goyang-Si, South Korea Abstract Disclosures Research Funding National Cancer Center Korea Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) during cytoreductive surgery has emerged to achieve a higher concentration of chemotherapeutic agents and treat micro-metastases on peritoneal surfaces. At advanced staged ovarian cancer treated with neoadjuvant chemotherapy, HIPEC during interval cytoreductive surgery with cisplatin 75-100mg/m 2 increases progression-free survival and overall survival (OV-HIPEC-01 and KOV-HIPEC-01). In chemotherapy-naïve ovarian cancer patients, survival benefit is not identified with HIPEC (KOV-HIPEC-01). And the meta-analysis revealed the survival benefit after recent exposure of chemotherapy. In ovarian cancer, HIPEC is thought to overcome chemotherapy resistance. Methods: This trial (KOV-02) is currently actively enrolling, 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). Institutional review board approval was obtained. The first patient was enrolled on April 07, 2022. The experimental arm will receive cytoreductive surgery and HIPEC (Doxorubicin 35mg/m 2 and mitomycin 15mg/m 2 , 41.5-42.0°C) followed by physician-choice chemotherapy, and the control arm will receive physician-choice chemotherapy until disease progression or intolerable toxicity. The primary objective of the trial is to evaluate progression-free survival (PFS) between the HIPEC group and the control group. Secondary objectives are overall survival (OS), cancer-specific survival, safety, and quality of life. Assuming that the enrollment period is three years and the follow-up period is two 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 of 0.05 and 80% power is 126. Considering 10% drop-out, 140 patients are finally studied. Clinical trial information: NCT05316181.

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