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EV278/#780  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. Myong Cheol Lim1,
  2. Ji Hyun Kim1,
  3. Boram Park2,
  4. Jae Kyung Bae1,
  5. Uisuk Kim1,
  6. Junhwan Kim1,
  7. Jung-Yun Kim1,
  8. Benoit You3 and
  9. Sang-Yoon Park1
  1. 1National Cancer Center, Gynecologic Cancer Cancer, Goyang-si, Gyeonggi-do, Korea, Republic of
  2. 2Samsung Medical Center, Biomedical Statistics Center, Research Institute for Future Medicine, Seoul, Korea, Republic of
  3. 3Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Lyon, France

Abstract

Introduction The addition of HIPEC during interval cytoreductive surgery improves PFS and OS in stage III ovarian cancer (OV-01 and KOV-01 trials). This trial aims to assess HIPEC’s survival benefit in stage III & IV ovarian cancer amidst maintenance therapy with bevacizumab and/or PARP inhibitors.

Methods The trial is registered on ClinialTrials.gov (NCT05827523). Ovarian cancer patients will be randomized at the time of interval cytoreductive surgery with residual disease < 2.5mm 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. The primary objective of the trial is to evaluate OS in two groups. Secondary objectives are PFS, cancer-specific survival, time to first subsequent therapy (TFST), safety, CA-125 KELIM, 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. Until April 2024, 143 (28.0%) patients are randomized.

Results There are no available results at the time of submission.

Conclusion/Implications The role of HIPEC during interval cytoreductive surgery will be discovered in stage III & IV ovarian cancer with this randomized trial (KOV-04) for the first time.

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