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)
- Author:
Bo Seong YUN
1
;
Kwang-Beom LEE
;
Keun Ho LEE
;
Ha Kyun CHANG
;
Joo-Young KIM
;
Myong Cheol LIM
;
Chel Hun CHOI
;
Hanbyoul CHO
;
Dae-Yeon KIM
;
Yun Hwan KIM
;
Joong Sub CHOI
;
Chae Hyeong LEE
;
Jae-Weon KIM
;
Sang Wun KIM
;
Yong Bae KIM
;
Chi-Heum CHO
;
Dae Gy HONG
;
Yong Jung SONG
;
Seob JEON
;
Min Kyu KIM
;
Dae Hoon JEONG
;
Hyun PARK
;
Seok Mo KIM
;
Sang-Il PARK
;
Jae-Yun SONG
;
Asima MUKHOPADHYAY
;
Dang Huy Quoc THINH
;
Nirmala Chandralega KAMPAN
;
Grace J. LEE
;
Jae-Hoon KIM
;
Keun-Yong EOM
;
Ju-Won ROH
Author Information
- Publication Type:Clinical Trial Protocol
- From:Journal of Gynecologic Oncology 2024;35(5):e57-
- CountryRepublic of Korea
- 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, 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.
