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TP007/#1438 Therapeutic effect of surgical debulking of metastatic lymph nodes in cervical cancer stage IIICR: a phase III, randomized controlled clinical trial (debulk trial)
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  1. Bo Seong Yun1,
  2. Kwang-Beom Lee2,
  3. Keun Ho Lee3,
  4. Ha Kyun Chang4,
  5. Joo-Young Kim5,
  6. Myong Cheol Lim6,
  7. Chel Hun Choi7,
  8. Dae-Yeon Kim8,
  9. Yun Hwan Kim9,
  10. Joong Sub Choi10,
  11. Chae Hyeong Lee11,
  12. Jae-Weon Kim12,
  13. Sang Wun Kim13,
  14. Yong Bae Kim14,
  15. Chi-Heum Cho15,
  16. Dae Gy Hong16,
  17. Yong Jung Song17,
  18. Jae-Hoon Kim18,
  19. Keun-Yong Eom19 and
  20. Ju-Won Roh1
  1. 1CHA Ilsan Medical Center, CHA University, Department of Obstetrics and Gynecology, Goyang-si, Korea, Republic of
  2. 2Gachon University Gil Medical Center, Gachon University College of Medicine, Department of Obstetrics and Gynecology, Incheon, Korea, Republic of
  3. 3The Catholic University of Korea, Seoul Saint. Mary’s Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  4. 4Korea University Ansan Hospital, Korea University School of Medicine, Department of Obstetrics and Gynecology, Ansan, Korea, Republic of
  5. 5Research Institute and Hospital, National Cancer Center, Department of Radiation Oncology, Goyang, Korea, Republic of
  6. 6National Cancer Center, Center For Gynecologic Cancer, Goyang-si, Korea, Republic of
  7. 7Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  8. 8Seoul Asan Medical Center, University of Ulsan College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  9. 9Ewha Womans University College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  10. 10Hanyang University College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  11. 11Dongguk University Ilsan Hospital, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  12. 12Seoul National University Hospital, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  13. 13Institute of Women’s Medical Life Science, Yonsei University College of Medicine, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  14. 14Yonsei Cancer Center, Yonsei University College of Medicine, Radiation Oncology, Seoul, Korea, Republic of
  15. 15Keimyung University School of Medicine, Department of Obstetrics and Gynecology, Daegu, Korea, Republic of
  16. 16Kyungpook National University Chilgok Hospital, Department of Obstetrics and Gynecology, Daegu, Korea, Republic of
  17. 17Pusan National University School of Medicine, Department of Obstetrics and Gynecology, Yangsan, Korea, Republic of
  18. 18Gangnam Severance Hospital, Yonsei University, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  19. 19Seoul National University Bundang Hospital, Department of Radiation Oncology, Seongnam, Korea, Republic of

Abstract

Objectives 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 the 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-centre, randomized clinical trial of patients with bulky or multiple LN 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 from sixteen Korean institutions (117 patients per each group) within 4 years. The primary endpoint is 3-year progression free survival (PFS) rate.

Results Trial in progress: there are no available results at the time of submission

Conclusions Trial in progress: there are no available conclusions at the time of submission

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