J Gynecol Oncol.
2024 Sep;35(5):e57. 10.3802/jgo.2024.35.e57.
Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
- Yun BS
1 - Lee KB2
- Lee KH3
- Chang HK4
- Kim JY5
- Lim MC6
- Choi CH7
- Cho H8
- Kim DY9
- Kim YH10
- Choi JS11
- Lee CH12
- Kim JW13
- Kim SW14
- Kim YB15
- Cho CH16
- Hong DG17
- Song YJ18
- Jeon S19
- Kim MK20
- Jeong DH21
- Park H22
- Kim SM23
- Park SI24
- Song JY25
- Mukhopadhyay A26
- Thinh DHQ27
- Kampan NC28
- Lee GJ29
- Kim JH8
- Eom KY30
- Roh JW1
- Affiliations
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- 1Department of Obstetrics and Gynecology, CHA Ilsan Medical Center, CHA University, Goyang, Korea
- 2Department of Obstetrics and Gynecology, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
- 3Department of Obstetrics and Gynecology, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 4Department of Obstetrics and Gynecology, Korea University Ansan Hospital, Korea University School of Medicine, Ansan, Korea
- 5Department of Radiation Oncology, Research Institute and Hospital, National Cancer Center, Goyang, Korea
- 6Center for Gynecologic Cancer & Center for Clinical Trials, Research Institute and Hospital, National Cancer Center, Goyang, Korea
- 7Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- 8Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- 9Department of Obstetrics and Gynecology, Seoul Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
- 10Department of Obstetrics and Gynecology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea
- 11Division of Gynecologic Oncology and Gynecologic Minimally Invasive Surgery, Department of Obstetrics and Gynecology, Hanyang University College of Medicine, Seoul, Korea
- 12Department of Obstetrics and Gynecology, Dongguk University Ilsan Hospital, Goyang, Korea
- 13Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea
- 14Department of Obstetrics and Gynecology, Women’s Cancer Center, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
- 15Department of Radiation Oncology, Women’s Cancer Center, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
- 16Department of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu, Korea
- 17Department of Obstetrics and Gynecology, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Korea
- 18Department of Obstetrics and Gynecology, Pusan National University College of Medicine, Yangsan, Korea
- 19Department of Obstetrics and Gynecology, College of Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea
- 20Department of Obstetrics and Gynecology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
- 21Department of Obstetrics and Gynecology, Inje University Busan Paik Hospital, Busan, Korea
- 22Comprehensive Gynecologic Cancer Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea
- 23Department of Obstetrics and Gynecology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
- 24Department of Obstetrics and Gynecology, Dongnam Institute of Radiological & Medical Sciences, Busan, Korea
- 25Department of Obstetrics and Gynecology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
- 26Kolkata Gynecological Oncology Trials and Translational Research Group, Chittaranjan National Cancer Institute, Kolkata, India
- 27Department of Radiation Oncology, Ho Chi Minh City Oncology Hospital, Ho Chi Minh City, Vietnam
- 28Department of Obstetrics and Gynaecology, Faculty of Medicine, University Kebangsaan Malaysia, Kuala Lumpur, Malaysia
- 29Department of Linguistics, Dartmouth College, Hanover, NH, USA
- 30Department of Radiation Oncology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
- KMID: 2564946
- DOI: http://doi.org/10.3802/jgo.2024.35.e57
Abstract
- Background
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. 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 of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously. The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
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