학술논문
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).
Document Type
Academic Journal
Author
Yun BS; Department of Obstetrics and Gynecology, CHA Ilsan Medical Center, CHA University, Goyang, Korea.; Lee KB; Department of Obstetrics and Gynecology, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.; Lee KH; Department of Obstetrics and Gynecology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.; Chang HK; Department of Obstetrics and Gynecology, Korea University Ansan Hospital, Korea University School of Medicine, Ansan, Korea.; Kim JY; Department of Radiation Oncology, Research Institute and Hospital, National Cancer Center, Goyang, Korea.; Lim MC; Center for Gynecologic Cancer & Center for Clinical Trials, Research Institute and Hospital, National Cancer Center, Goyang, Korea.; Choi CH; Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.; Cho H; Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.; Kim DY; Department of Obstetrics and Gynecology, Seoul Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.; Kim YH; Department of Obstetrics and Gynecology, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, Korea.; Choi JS; Division of Gynecologic Oncology and Gynecologic Minimally Invasive Surgery, Department of Obstetrics and Gynecology, Hanyang University College of Medicine, Seoul, Korea.; Lee CH; Department of Obstetrics and Gynecology, Dongguk University Ilsan Hospital, Goyang, Korea.; Kim JW; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Korea.; Kim SW; Department of Obstetrics and Gynecology, Women's Cancer Center, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.; Kim YB; Department of Radiation Oncology, Women's Cancer Center, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.; Cho CH; Department of Obstetrics and Gynecology, Keimyung University School of Medicine, Daegu, Korea.; Hong DG; Department of Obstetrics and Gynecology, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Korea.; Song YJ; Department of Obstetrics and Gynecology, Pusan National University College of Medicine, Yangsan, Korea.; Jeon S; Department of Obstetrics and Gynecology, College of Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.; Kim MK; Department of Obstetrics and Gynecology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.; Jeong DH; Department of Obstetrics and Gynecology, Inje University Busan Paik Hospital, Busan, Korea.; Park H; Comprehensive Gynecologic Cancer Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea.; Kim SM; Department of Obstetrics and Gynecology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea.; Park SI; Department of Obstetrics and Gynecology, Dongnam Institute of Radiological & Medical Sciences, Busan, Korea.; Song JY; Department of Obstetrics and Gynecology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.; Mukhopadhyay A; Kolkata Gynecological Oncology Trials and Translational Research Group, Chittaranjan National Cancer Institute, Kolkata, India.; Thinh DHQ; Department of Radiation Oncology, Ho Chi Minh City Oncology Hospital, Ho Chi Minh City, Vietnam.; Kampan NC; Department of Obstetrics and Gynaecology, Faculty of Medicine, University Kebangsaan Malaysia, Kuala Lumpur, Malaysia.; Lee GJ; Department of Linguistics, Dartmouth College, Hanover, NH, USA.; Kim JH; Department of Obstetrics and Gynecology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.; Eom KY; Department of Radiation Oncology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.; Roh JW; Department of Obstetrics and Gynecology, CHA Ilsan Medical Center, CHA University, Goyang, Korea. rohjuwon@hanmail.net.
Source
Publisher: Asian Society of Gynecologic Oncology Country of Publication: Korea (South) NLM ID: 101483150 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2005-0399 (Electronic) Linking ISSN: 20050380 NLM ISO Abbreviation: J Gynecol Oncol Subsets: MEDLINE
Subject
Language
English
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, well-planned 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/m²), 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.
Trial Registration: ClinicalTrials.gov Identifier: NCT05421650; Clinical Research Information Service Identifier: KCT0007137.
Competing Interests: Yong Bae Kim received research funding from the National R&D Program for Cancer Control through the National Cancer Center (NCC) funded by the Ministry of Health & Welfare, Republic of Korea (HA22C0021) and 2023 Bio Industry Technology Development Project funded by Ministry of Trade, Industry and Energy (20024089). Asima Mukhopadhyay received honoraria from the National R&D Program for Cancer Control through the National Cancer Center (NCC) funded by the Ministry of Health & Welfare, Republic of Korea (HA22C0083) for her lecture presented at the 2022 Asian Society of Gynecologic Oncology (ASGO) webinar. Nirmala Chandralega Kampan received support for attending the meeting from Roche.
(© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)
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/m²), 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.
Trial Registration: ClinicalTrials.gov Identifier: NCT05421650; Clinical Research Information Service Identifier: KCT0007137.
Competing Interests: Yong Bae Kim received research funding from the National R&D Program for Cancer Control through the National Cancer Center (NCC) funded by the Ministry of Health & Welfare, Republic of Korea (HA22C0021) and 2023 Bio Industry Technology Development Project funded by Ministry of Trade, Industry and Energy (20024089). Asima Mukhopadhyay received honoraria from the National R&D Program for Cancer Control through the National Cancer Center (NCC) funded by the Ministry of Health & Welfare, Republic of Korea (HA22C0083) for her lecture presented at the 2022 Asian Society of Gynecologic Oncology (ASGO) webinar. Nirmala Chandralega Kampan received support for attending the meeting from Roche.
(© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.)