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Poster Display

81TiP - 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

Date

20 Jun 2024

Session

Poster Display

Presenters

Jaekyung Bae

Citation

Annals of Oncology (2024) 9 (suppl_5): 1-19. 10.1016/esmoop/esmoop103501

Authors

J. Bae1, J.H. Kim1, E.Y. Park1, D.H. Jeong2, Y. Lee3, C.H. Choi4, S. Lee5, S. Lee6, J. Park6, S.I. Kim7, J.C. Baek8, D.G. Hong9, H.I. Ha10, Y. Song10, S. Jeon11, T.S. Lee12, H.W. Jeon13, K.H. Kim14, S. Park1, M. Lim15

Author affiliations

  • 1 NCC - National Cancer Center, Goyang/KR
  • 2 Inje University Busan Paik Hospital, Busan/KR
  • 3 Samsung Medical Center (SMC), Seoul/KR
  • 4 Samsung Medical Center (SMC)-Sungkyunkwan University School of Medicine, Seoul/KR
  • 5 The Catholic University of Korea - Seoul St. Mary's Hospital - Catholic Medical Center, Seoul/KR
  • 6 Asan Medical Center - University of Ulsan, Seoul/KR
  • 7 Seoul National University - College of Medicine - Yeongeon Medical Campus, Seoul/KR
  • 8 Gyeongsang National University, Jinju/KR
  • 9 KNU - Kyungpook National University, Daegu/KR
  • 10 Pusan National University Yangsan Hospital, Yangsan/KR
  • 11 Soonchunhyang University Cheonan Hospital, Cheonan/KR
  • 12 Boramae Medical Center, Seoul/KR
  • 13 SMG-SNU Boramae Medical Center, Seoul/KR
  • 14 Pusan National University Hospital, Busan/KR
  • 15 National Cancer Center Korea, Goyang-si/KR

Resources

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Abstract 81TiP

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 (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.

Trial Design

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/m2 and mitomycin 15mg/m2, 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 identification

NCT05316181, 2022-03-03.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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