Rationale and study design of the KOV-HIPEC-02R (RECOVER): A randomized, multicenter, open-label phase III trial of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer.
TPS5628 Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) administered during interval cytoreductive surgery following neoadjuvant chemotherapy has shown to increase progression-free survival (PFS) and overall survival (OS) rates, as indicated by the OV-HIPEC-01 and KOV-HIPEC-01 trials. A recent meta-analysis (Kim SI, Kim JH, et al., GO 2023) demonstrated a survival benefit associated with HIPEC, particularly after recent exposure of chemotherapy. Moreover, in ovarian cancer, HIPEC is suggested to be effective in overcoming chemotherapy resistance. Methods: This trial (KOV-02R, RECOVER) is a multicenter, open-label, 1:1 randomized, phase III trial that will enroll 140 patients with platinum-resistant recurrent epithelial ovarian cancer (NCT05316181). After cytoreductive surgery, patients undergo the HIPEC procedure at 41.5°C, with doxorubicin at 35mg/ m 2 and mitomycin at 15mg/m 2 . Enrolled patients receive non-platinum compound systemic chemotherapy until disease progression. The primary objective is to evaluate progression-free survival between the HIPEC group and the control group. Secondary objectives include overall survival, cancer-specific survival, and safety and quality of life. Considering a 5-year enrollment period, 2-year follow-up, and a statistical power of 80%, 140 patients are needed, accounting for a 10% dropout rate. As of January 10, 2025, 115 patients (82.1%) have been randomized. Clinical trial information: NCT05316181 .
Authors
- Shin‐Wha Lee (ORCID: https://orcid.org/0000-0002-5088-1905)
- Jeong‐Yeol Park (ORCID: https://orcid.org/0000-0003-2475-7123)
- Myong Cheol Lim (ORCID: https://orcid.org/0000-0001-8964-7158)
- Se Ik Kim (ORCID: https://orcid.org/0000-0002-9790-6735)
- Yun Hwan Kim (ORCID: https://orcid.org/0000-0001-9498-2938)
- Yoo-Young Lee (ORCID: https://orcid.org/0000-0001-5902-9877)
- Sungjong Lee (ORCID: https://orcid.org/0000-0003-3824-6092)
- Jae Yun Song
- Taek Sang Lee (ORCID: https://orcid.org/0000-0001-8119-5601)
- Chel Hun Choi (ORCID: https://orcid.org/0000-0002-0199-6669)
- Hyeong In Ha (ORCID: https://orcid.org/0000-0002-7045-7976)
- Dae Hoon Jeong (ORCID: https://orcid.org/0000-0001-9354-5496)
- Uisuk Kim (ORCID: https://orcid.org/0000-0002-1279-3701)
- Jin Hwa Hong (ORCID: https://orcid.org/0000-0002-6905-5363)
- Sang‐Yoon Park (ORCID: https://orcid.org/0000-0001-7624-3373)
- Ki Hyung Kim (ORCID: https://orcid.org/0000-0003-2364-5875)
- Heon Yoo (ORCID: https://orcid.org/0000-0001-6186-3262)
- Yong Jung Song (ORCID: https://orcid.org/0000-0002-6103-2466)
- Ji Hyun Kim (ORCID: https://orcid.org/0000-0002-4746-5572)
- Eun Young Park (ORCID: https://orcid.org/0000-0003-4859-6782)
Institutions
- Ewha Womans University (KR)
- Seoul National University (KR)
- Korea University (KR)
- Korea University Medical Center (KR)
- Asan Medical Center (KR)
- Samsung Medical Center (KR)
- SNUH SMG-SNU Boramae Medical Center (KR)
- Inje University Busan Paik Hospital (KR)
- Pusan National University Hospital (KR)
- National Cancer Center (KR)
- Pusan National University Yangsan Hospital (KR)
- The Catholic University of Korea Seoul St. Mary's Hospital (KR)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2025-05-28
- DOI
- https://doi.org/10.1200/jco.2025.43.16_suppl.tps5628
- Primary Topic
- Intraperitoneal and Appendiceal Malignancies
- Type
- article
- Field-Weighted Citation Impact
- 0.00