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TP017/#812  A phase III randomized controlled trial in primary stage three and four ovarian cancer after interval cytoreductive surgery (FOCUS/KOV-HIPEC-04)
  1. Ji Hyun Kim1,
  2. Boram Park2,
  3. Jeong-Yeol Park3,
  4. Jung-Yun Lee4,
  5. Suk-Joon Chang5,
  6. Yoo Young Lee6,
  7. Dae Gy Hong7,
  8. Hyun Woong Cho8,
  9. Jae Yun Song9,
  10. Jung-Yun Kim1,
  11. Sang-Yoon Park10 and
  12. Myong Cheol Lim10
  1. 1National Cancer Center, Center for Gynecologic Cancer, Goyang, Korea, Republic of
  2. 2Samsung Medical Center, Biomedical Statistics Center, Research Institute for Future Medicine, Seoul, Korea, Republic of
  3. 3Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  4. 4Yonsei University College of Medicine, Department of Obstetrics and Gynecology, Women’s Cancer Center, Yonsei Cancer Center, Institute of Women’s Life Medical Science, Seoul, Korea, Republic of
  5. 5Ajou University Medical Center, Obstetrics and Gynecology, Suwon, Korea, Republic of
  6. 6Samsung Medical Center, Obstetrics and Gynecology, Seoul, Korea, Republic of
  7. 7Kyungpook National University Chilgok Hospital, Department of Obstetrics and Gynecology, Daegu, Korea, Republic of
  8. 8Korea University Guro Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  9. 9Korea University College of Medicine, Obstetrics and Gynecology, Seoul, Korea, Republic of
  10. 10Center for Gynecologic Cancer, National Cancer Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of


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. (NCT05827523)

Current Trial Status Not yet Recruiting

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