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  • TP005/#1524  Therapeutic effect of surgical debulking of metastatic lymph nodes in cervical cancer stage IIICR: a phase III, randomized controlled clinical trial (KGOG1047; Debulk trial)

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ePoster Viewing: Trials-in-Progress
AS03. Cervical cancer
TP005/#1524  Therapeutic effect of surgical debulking of metastatic lymph nodes in cervical cancer stage IIICR: a phase III, randomized controlled clinical trial (KGOG1047; Debulk trial)
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  1. Ju-Won Roh1,
  2. Bo Seong Yun1,
  3. Kwang-Beom Lee2,
  4. Keun Ho Lee3,
  5. Ha Kyun Chang4,
  6. Myong Cheol Lim5,
  7. Chel Hun Choi6,
  8. Hanbyoul Cho7,
  9. Dae-Yeon Kim8,
  10. Yun Hwan Kim9,
  11. Joong Sub Choi10,
  12. Chae-Hyeong Lee11,
  13. Jae-Weon Kim12,
  14. Sang Wun Kim13,
  15. Chi-Heum Cho14,
  16. Dae-Gy Hong15,
  17. Yong Jung Song16,
  18. Joo-Young Kim17,
  19. Yong Bae Kim18,
  20. Keun-Yong Eom19 and
  21. Jae-Hoon Kim20
  1. 1CHA Ilsan Medical Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  2. 2Gachon University Gil Medical Center, Department of Obstetrics and Gynecology, Incheon, Korea, Republic of
  3. 3Seoul St. Mary’s Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  4. 4Korea University Ansan Hostpital, Department of Obstetrics and Gynecology, Ansan, Korea, Republic of
  5. 5National Cancer Center, Center for Gynecologic Cancer, Goyang, Korea, Republic of
  6. 6Samsung Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  7. 7Gangnam Severance Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  8. 8Asan Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  9. 9Ewha womans university Mokdong Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  10. 10Hanyang College of Medicine, Obstetrics and Gynecology, Seongdong-gu, Korea, Republic of
  11. 11Dongguk University Ilsan Hospital, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  12. 12Seoul National University, Obstetrics and Gynecology, Seoul, Korea, Republic of
  13. 13Yonsei University College of Medicine, Obstetrics and Gynecology, Seoul, Korea, Republic of
  14. 14Keimyung University Dongsan Medical Center, Department of Obstetrics and Gynecology, Daegu, Korea, Republic of
  15. 15Kyungpook National University Chilgok Hospital, Department of Obstetrics and Gynecology, Daegu, Korea, Republic of
  16. 16Yangsan Pusan National University Hospital, Obstetrics and Gynecology, Yangsan, Korea, Republic of
  17. 17National Cancer Center, Korea, Radiation Oncology, Goyang-si, Gyeonggi-do, Korea, Republic of
  18. 18Yonsei Cancer Center, Yonsei University, Radiation Oncology, Seoul, Korea, Republic of
  19. 19Seoul National University Bundang Hospital, Radiation Oncology, Seongnam, Korea, Republic of
  20. 20Institute of Women’s Life Medical Science, Yonsei University College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of

Abstract

Introduction Bulky or multiple lymph node (LN) metastasis has been reported to have poor prognosis in cervical cancer and the size or number of LN metastasis is not yet reflected in both the staging system and treatment modality. The therapeutic effect of surgical resection of bulky lymph node before standard treatment has been reported in several retrospective studies. However, there are lack of well-planned randomized clinical study. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate in cervical cancer IIICr as diagnosed by imaging.

Methods The KGOG 1047/DEBULK trial is a phase III, multi-center, randomized clinical trial of patients with bulky or multiple lymph node metastasis in cervical cancer IIICr. This study included patients with a short-axis of a pelvic or paraaortic LN ≥ 2 cm or more than 3 LNs with a short axis ≥ 1 cm and for whom CCRT is planned. The treatment arms will randomly be allocated to undergo either CCRT (control arm) or surgical debulking of bulky or multiple LNs prior to CCRT (experimental arm). Total 234 patients will be included (117 patients per each group) within 4 years. The primary endpoint is 3-year progression free survival. The secondary endpoints are the treatment-related complications and the radiologic accuracy.

Current Trial Status Twenty-two Korean institutions have confirmed their participation, and are preparing for international joint research with India, Vietnam, and Malaysia. There are currently 15 patients enrolled.

Abstract TP005/#1524 Figure 1
Abstract TP005/#1524 Figure 1

https://doi.org/10.1136/ijgc-2023-IGCS.468

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