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  • TP018/#822  A randomized, multicenter, open-label phase III trial of hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer

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ePoster Viewing: Trials-in-Progress
AS11. Ovarian cancer
TP018/#822  A randomized, multicenter, open-label phase III trial of hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer
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  1. Ji Hyun Kim1,
  2. Eun-Young Park2,
  3. Dae Hoon Jeong3,
  4. Yoo Young Lee4,
  5. Chel Hun Choi5,
  6. Tae-Joong Kim6,
  7. Hyun Hoon Chung7,
  8. Taek Sang Lee8,
  9. Shin Wha Lee9,
  10. Jeong-Yeol Park9,
  11. Sung Jong Lee10,
  12. Seob Jeon11,
  13. Ki Hyung Kim12,
  14. Hyeong In Ha13,
  15. Youngbok Ko14,
  16. San-Hui Lee15,
  17. Suk-Joon Chang16,
  18. Sang-Yoon Park17 and
  19. Myong Cheol Lim17
  1. 1National Cancer Center, Center for Gynecologic Cancer, Goyang, Korea, Republic of
  2. 2National Cancer Center Korea, Biostatistics Collaboration Team, Go-Yang si, Korea, Republic of
  3. 3Busan Paik Hospital, College of Medicine, Inje University, Department of Obstetrics and Gynecology, Busan, Korea, Republic of
  4. 4Samsung Medical Center, Obstetrics and Gynecology, Seoul, Korea, Republic of
  5. 5Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  6. 6Samsung Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  7. 7Seoul National University Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  8. 8Seoul Metropolitan Government Seoul National University Boramae Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  9. 9Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  10. 10Seoul St. Mary’s Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  11. 11Soonchunhyang University Cheonan Hospital, Department of Obstetrics and Gynecology, Chunan, Korea, Republic of
  12. 12Pusan National University Hospital, Department of Obstetrics and Gynecology, Pusan, Korea, Republic of
  13. 13Pusan Yangsan National University Hospital, Department of Obstetrics and Gynecology, Pusan, Korea, Republic of
  14. 14Chungnam National University Hospital, Department of Obstetrics and Gynecology, Daejeon, Korea, Republic of
  15. 15Yonsei University Wonju College of Medicine, Department of Obstetrics and Gynecology, Wonju, Korea, Republic of
  16. 16Ajou University Medical Center, Obstetrics and Gynecology, Suwon, Korea, Republic of
  17. 17Center for Gynecologic Cancer, National Cancer Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of

Abstract

Introduction Recent randomized trials (OV-HIPEC-01 and KOV-HIPEC-01) and meta-analyses reveal survival benefits of HIPEC after recent exposure of systemic chemotherapy exposure in ovarian cancer.

Methods This trial (KOV-HIPEC-02) is 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). The experimental arm will receive HIPEC (41.0–42.0°C, doxorubicin 35 mg/m2 and mitomycin 15 mg/m2, 90 min) followed by physician’s choice chemotherapy, and the control arm will receive physician’s choice chemotherapy without HIPEC until disease progression or unacceptable toxicities. The primary objective of the trial is to evaluate progression-free survival (PFS). Secondary objectives are overall survival (OS), cancer-specific survival, safety, and quality of life. Assuming that the enrollment period is 3 years and the follow-up period is 2 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 0.05 and 80% power is 126. 140 patients are finally studied considering 10% drop-out.

Current Trial Status Active Recruiting

Abstract TP018/#822 Figure 1
Abstract TP018/#822 Figure 1

https://doi.org/10.1136/ijgc-2023-IGCS.478

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