Article Text
PDF
Abstract
Introduction/Background Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer. The size or number of LN metastasis is not yet reflected in both the staging system and the treatment modality of cervical cancer. 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.
Methodology 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 ≥ 2cm or ≥ 3 LNs with a short-axis diameter ≥ 1cm and for whom CCRT is scheduled. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of 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.
Results 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 the accuracy of radiological diagnosis of bulky or multiple LNs.
Conclusion Currently, 23 institutions in Korea and 4 oversea institutions in India, Malaysia, Vietnam, and China, are participating in this trial. The KGOG 1047/DEBULK trial is expected to develop the best strategy for treating stage IIIC cervical cancer by providing prospective results of the efficacy of surgical resection of metastatic LNs.
Disclosures This study was supported by the National R&D Program for Cancer Control through the National Cancer Center funded by the Ministry of Health & Welfare, Republic of Korea.
