THERAPEUTIC EFFECT OF SURGICAL DEBULKING OF METASTATIC LYMPH NODES IN CERVICAL CANCER STAGE IIICR: A PHASE III, RANDOMIZED CONTROLLED CLINICAL TRIAL (DEBULK TRIAL)

Abstract

Objectives Bulky or multiple lymph node (LN) metastasis has been reported to have poor prognosis in cervical cancer and the size or number of LN metastasis is not yet reflected in both the staging system and the treatment modality. The therapeutic effect of surgical resection of bulky lymph node before standard treatment has been reported in several retrospective studies. However, there are lack of well-planned randomized clinical study. 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 in cervical cancer IIICr as diagnosed by imaging.

Methods The KGOG 1047/DEBULK trial is a phase III, multi-centre, randomized clinical trial of patients with bulky or multiple LN metastasis in cervical cancer IIICr. This study included patients with a short-axis of a pelvic or paraaortic LN ≥ 2 cm or more than 3 LNs with a short axis ≥ 1 cm and for whom CCRT is planned. The treatment arms will randomly be allocated to undergo either CCRT (control arm) or surgical debulking of bulky or multiple LNs prior to CCRT (experimental arm). Total 234 patients will be included from sixteen Korean institutions (117 patients per each group) within 4 years. The primary endpoint is 3-year progression free survival (PFS) rate.

Results Trial in progress: there are no available results at the time of submission

Conclusions Trial in progress: there are no available conclusions at the time of submission