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  • TP024/#1560  Standard of care therapy with or without stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC): a prospective randomized phase III trial (KGOG 3064/KROG 2204)

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ePoster Viewing: Trials-in-Progress
AS11. Ovarian cancer
TP024/#1560  Standard of care therapy with or without stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC): a prospective randomized phase III trial (KGOG 3064/KROG 2204)
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  1. Chan Woo Wee1,
  2. So-Jin Shin2,
  3. Jae Hong No3,
  4. Keun Ho Lee4,
  5. Myong Cheol Lim5,
  6. Jae-Weon Kim6,
  7. Won Kyung Cho7,
  8. Min Sun Kyung8,
  9. Jae Yun Song9,
  10. Kyung Jin Min10,
  11. Eun Ji Lee11,
  12. Seob Jeon12,
  13. Jae-Hoon Kim13,
  14. Young Seok Kim14,
  15. Ju-Won Roh15,
  16. Jong Hoon Lee16,
  17. Youngmin Choi17,
  18. Hyun Ju Kim18,
  19. Yun Hwan Kim19 and
  20. Yong Bae Kim1
  1. 1Yonsei Cancer Center, Department of Radiation Oncology, Seoul, Korea, Republic of
  2. 2Keimyung University School of Medicine, Department of Obstetrics and Gynecology, Daegu, Korea, Republic of
  3. 3Seoul National University Bundang Hospital, Department of Obstetrics and Gynecology, Seongnam, Korea, Republic of
  4. 4Seoul St. Mary’s Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  5. 5Center for Gynecologic Cancer, National Cancer Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  6. 6Seoul National University Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  7. 7Samsung Medical Center, Department of Radiation Oncology, Seoul, Korea, Republic of
  8. 8Hallym University Dongtan Sacred Heart Hospital, Department of Obstetrics & Gynecology, Hwaseong, Korea, Republic of
  9. 9Korea University Anam Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  10. 10Korea University Ansan Hostpital, Department of Obstetrics and Gynecology, Ansan, Korea, Republic of
  11. 11Department of Obstetrics and Gynecology, Chung-ang University Hospital, Seoul, Korea, Republic of
  12. 12Soonchunhyang University Cheonan Hospital, Department of Obstetrics and Gynecology, Chunan, Korea, Republic of
  13. 13Gangnam Severance Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  14. 14Asan Medical Center, Department of Radiation Oncology, Seoul, Korea, Republic of
  15. 15CHA Ilsan Medical Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  16. 16St Vincent’s Hospital, Department of Radiation Oncology, Suwon, Korea, Republic of
  17. 17Dong-A University School of Medicine, Department of Radiation Oncology, Busan, Korea, Republic of
  18. 18Gachon University Gil Hospital, Department of Radiation Oncology, Incheon, Korea, Republic of
  19. 19Ewha Womans University College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of

Abstract

Introduction Despite the controversial role of radiotherapy (RT) in recurrent ovarian cancer (ROC), there might be a survival benefit irrespective of favorable clinical features according to a preliminary analysis. This prospective study was designed to compare the survival outcomes between standard of care (SOC) with or without stereotactic ablative RT (SABR) to all recurrent sites in ROC.

Methods Patients with recurrent epithelial ovarian cancer with 10 or less metastatic sites at recurrence based on the number of SABR fields are eligible. Those who have a history of RT, single lesion sized >5 cm, or diffuse peritoneal carcinomatosis are not eligible. Patients will be stratified by factors as the followings; number of favorable factors (absence of ascites, platinum-sensitivity, CA-125, and ECOG performance), location of the lesion (lymph node vs. non-lymph node), and use of PARP inhibitor. Patients will be randomized (1:2) into SOC salvage treatment (arm 1) vs. SOC plus metastasis-directed SABR (arm 2). The primary endpoint is 3-year overall survival rate (58.5% for arm 1 and 74.4% for arm 2). A total of 270 patients will be required.

Current Trial Status A dummy-run study involving 4 representative clinical scenarios is under progress. To enhance compliance with the protocols, a three-tiered RT quality assurance (QA) process consisting of general credentialing, trial-specific credentialing with dummy run plus phantom QA, and individual case review has been performed. Currently, 32 patients from 16 sites are enrolled as of August 21st, 2023.

https://doi.org/10.1136/ijgc-2023-IGCS.484

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