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253 Rationale and study design of the KOV-HIPEC-04: a phase III randomized controlled trial in primary stage three and four ovarian cancer after interval cytoreductive surgery (FOCUS)
  1. Ji Hyun Kim1,
  2. Boram Park2,
  3. Jeong-Yeol Park3,
  4. Jung-Yun Lee4,
  5. Suk-Joon Chang5,
  6. Yoo-Young Lee2,
  7. Daegy Hong6,
  8. Hyun Woong Cho7,
  9. Hyeong In Ha8,
  10. Yong Jung Song8,
  11. Ki Hyung Kim9 and
  12. Sang-Yoon Park10
  1. 1National Cancer Center, Goyang-Si, South Korea
  2. 2Samsung Medical Center, Seoul, South Korea
  3. 3Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, South Korea
  4. 4Yonsei University College of Medicine, Seoul, South Korea
  5. 5Ajou University School of Medicine, Suwon, South Korea
  6. 6Kyungpook National University Medical Center, Daegu, South Korea
  7. 7Korea University College of Medicine, Seoul, South Korea
  8. 8Pusan National University Yangsan Hospital, Pusan, South Korea
  9. 9Pusan National University Hospital, Pusan, South Korea
  10. 10National Cancer Center, Goyang, South Korea


Introduction/Background The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery increases progression-free and overall survival for patients with stage III 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 stage III & IV ovarian cancer in the era of maintenance therapy of bevacizumab and/or PARP inhibitor.

Methodology Ovarian cancer patients will be randomized at the time of interval cytoreductive surgery with achieving complete cytoreduction or cytoreduction with no more than 2.5mm size of residual disease to receive HIPEC (41.5 cisplatin 75mg/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. 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.

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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