Article Text
Abstract
Objectives Sentinel lymph node (SLN) mapping has been suggested as an alternative surgical technique to lymph node dissection (LND) for early-stage endometrial cancer. However, the survival outcomes of SLN mapping compared with LND have not been established via prospective randomized controlled trials. The primary endpoint of the Gynecologic Oncology Group 2029 trial (KGOG2029/SELYE) is the 3-year disease-free survival (DFS) of SLN mapping versus LND. The secondary endpoints are 3-year overall survival (OS), 5-year DFS, 5-year OS, pattern of recurrence, immediate surgical outcomes, SLN mapping success rate, postoperative lymph-related complications, postoperative QOL, and the cost-effectiveness of SLN mapping versus LND.
Methods The KGOG2029/SEYLE trial is a multi-center, single-blind, randomized controlled trial which has been designed to determine the prognostic value of SLN mapping alone compared with conventional lymphadenectomy for patients with clinical stage I-II endometrial cancer of any histologic type and any histologic grade. Study patients will be classified into low/intermediate-risk and high-risk groups according to the risk of lymph node metastasis. A low/intermediate-risk group will undergo pelvic SLN mapping in SLN group and will undergo pelvic lymph node dissection in LND group. A high-risk group will undergo a 2-step SLN mapping procedure consisting of para-aortic SLN mapping (first step) and pelvic SLN mapping (second step) in SLN group and will undergo pelvic and para-aortic lymph node dissection in LND group. Eighty-one of planned 810 patients have been enrolled at the time of submission.
Results There are no available results at the time of submission.
Conclusions There are no available conclusions at the time of submission.