Proposal of a concept and design of a randomized phase III trial investigating the survival effect of para-aortic lymphadenectomy in endometrial cancer.
Although prospective studies have failed to show the therapeutic effect of lymphadenectomy in the surgical treatment of endometrial cancer, several retrospective studies including the SEPAL study revealed the survival effect of lymphadenectomy. To prospectively investigate the survival benefit of para-aortic lymphadenectomy shown in the SEPAL study, we are proposing a new concept of a randomized phase III trial. An appropriate study population will be selected according to the preoperative assessments (evaluation of myometrial invasion and cervical invasion with magnetic resonance imaging, extrauterine spread with computed tomography, and histological type and grade by pathological evaluation) to estimate the risk of lymph node metastasis. Patients relevant to potential International Federation of Gynecology and Obstetrics (2008) stage IB, II and III diseases will be eligible, and randomly assigned to two arms: pelvic lymphadenectomy alone (control), or pelvic and para-aortic lymphadenectomy (experimental). After initial surgery, patients with postoperative pathological risk factors for recurrence will receive adjuvant chemotherapy. Because we aim to investigate the therapeutic significance of primary treatments, including surgery and adjuvant chemotherapy, the primary end-point could be recurrence-free survival. One of the most important issues to successfully perform this prospective study is to assure the quality of lymphadenectomy (extent and area), which could be evaluated based on the number of harvested nodes and objective evaluation of dissected area by videos and/or photos.
Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Hidemichi
H
Watari
Yukiharu
Y
Todo
Sokbom
S
Kang
Tetsuji
T
Odagiri
Noriaki
N
Sakuragi
D000970:Antineoplastic Agents / Q000627:therapeutic use; D001011:Aorta; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy / Q000473:pathology* / Q000601:surgery*; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000592:standards; D008207:Lymphatic Metastasis; D009367:Neoplasm Staging; D018579:Patient Selection; D010388:Pelvis; D012107:Research Design; D015996:Survival Rate
D000970:Antineoplastic Agents
SEPAL study; endometrial cancer; lymphadenectomy; prospective study; survival