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252 Rationale and study design of the KOV-HIPEC-02 trial: a randomized, multicenter, open-label phase III trial of hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer
  1. Ji Hyun Kim1,
  2. Eun-Young Park1,
  3. Dae Hoon Jeong2,
  4. Yoo-Young Lee3,
  5. Chel Hoon Choi3,
  6. Hyun Hoon Chung4,
  7. Taek Sang Lee5,
  8. Hye Won Jeon5,
  9. Shin-Wha Lee6,
  10. Jeong-Yeol Park6,
  11. Sung Jong Lee7,
  12. Seob Jeon8,
  13. Ki Hyung Kim9,
  14. Jong Chul Baek10,
  15. Suk-Joon Chang11,
  16. Sang-Yoon Park12 and
  17. Myong Cheol Lim1
  1. 1National Cancer Center Korea, Goyang-Si, South Korea
  2. 2Busan Paik Hospital, Inje University, Busan, South Korea
  3. 3Samsung Medical Center, Seoul, South Korea
  4. 4Seoul National University College of Medicine, Seoul, South Korea
  5. 5Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, South Korea
  6. 6Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, South Korea
  7. 7Seoul St Mary’s Hospital, Seoul, South Korea
  8. 8Soonchunhyang University Cheonan Hospital, Cheonan, South Korea
  9. 9Pusan National University Hospital, Pusan, South Korea
  10. 10Gyeongsang National University, Jin-Ju, South Korea
  11. 11Ajou University School of Medicine, Suwon, South Korea
  12. 12National Cancer Center, Goyang-Si, South Korea


Introduction/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/m2 increases progression-free survival and overall survival (OVHIPEC-01 and KOVHIPEC-01). In chemotherapy-naïve ovarian cancer patients, survival benefit is not identified with HIPEC (KOVHIPEC-01). And the meta-analysis revealed the survival benefit after recent exposure of chemotherapy. In ovarian cancer, HIPEC is thought to overcome chemotherapy resistance.

Methodology This trial (KOVHIPEC-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 (NCT05316181). The first patient was enrolled Apr 07, 2022. The experimental arm will receive HIPEC followed by standard chemotherapy, and the control arm will receive standard chemotherapy without HIPEC until disease progression. If patients are assigned to the HIPEC group, the HIPEC procedure is carried out using the open or closed technique, infusing 41.5–42.0°C doxorubicin 35mg/m2 and mitomycin 15mg/m2. Enrolled patients will receive physician-choice non-platinum compound systemic chemotherapy until progression. 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 according to whether HIPEC was performed during surgery in patients with platinum-resistant recurrent ovarian cancer. 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. One hundred forty patients are finally studied, considering 10% drop-out.

Results N/A

Conclusion N/A

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.

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