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)

• Published in: Journal of gynecologic oncology Vol. 35; no. 5; pp. e57 - 11
• Main Authors: Yun, Bo Seong, Lee, Kwang-Beom, Lee, Keun Ho, Chang, Ha Kyun, Kim, Joo-Young, Lim, Myong Cheol, Choi, Chel Hun, Cho, Hanbyoul, Kim, Dae-Yeon, Kim, Yun Hwan, Choi, Joong Sub, Lee, Chae Hyeong, Kim, Jae-Weon, Kim, Sang Wun, Kim, Yong Bae, Cho, Chi-Heum, Hong, Dae Gy, Song, Yong Jung, Jeon, Seob, Kim, Min Kyu, Jeong, Dae Hoon, Park, Hyun, Kim, Seok Mo, Park, Sang-Il, Song, Jae-Yun, Mukhopadhyay, Asima, Thinh, Dang Huy Quoc, Kampan, Nirmala Chandralega, Lee, Grace J, Kim, Jae-Hoon, Eom, Keun-Yong, Roh, Ju-Won
• Format: Journal Article
• Language: English
• Published: Korea (South) Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology; Japan Society of Gynecologic Oncology 01.09.2024; 대한부인종양학회
• Subjects: Adult; Aged; Chemoradiotherapy - methods; Clinical Trial Protocol; Cytoreduction Surgical Procedures - methods; Female; Humans; Lymph Node Excision - methods; Lymph Nodes - pathology; Lymphatic Metastasis; Middle Aged; Randomized Controlled Trials as Topic; Uterine Cervical Neoplasms - pathology; Uterine Cervical Neoplasms - therapy; 산부인과학; Lymph Node Excision; Concurrent Chemoradiotherapy; Cervical Cancer; Lymph Node Metastasis; Bulky Lymph Node; Progression-Free Survival
• ISSN: 2005-0380; 2005-0399; 2005-0399
• DOI: 10.3802/jgo.2024.35.e57

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. 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. ClinicalTrials.gov Identifier: NCT05421650; Clinical Research Information Service Identifier: KCT0007137.