Lymphadenectomy in locally advanced cervical cancer study (LiLACS): Phase III clinical trial comparing surgical with radiologic staging in patients with stages IB2-IVA cervical cancer

J Minim Invasive Gynecol. Jan-Feb 2014;21(1):3-8. doi: 10.1016/j.jmig.2013.07.007. Epub 2013 Jul 31.

Abstract

Radiation treatment planning for women with locally advanced cervical cancer (stages IB2-IVA) is often based on positron emission tomography (PET). PET, however, has poor sensitivity in detecting metastases in aortocaval nodes. We have initiated a study with the objective of determining whether pre-therapeutic laparoscopic surgical staging followed by tailored chemoradiation improves survival as compared with PET/computed tomography (CT) radiologic staging alone followed by chemoradiation. This international, multicenter phase III trial will enroll 600 women with stages IB2-IVA cervical cancer and PET/CT findings showing fluorodeoxyglucose-avid pelvic nodes and fluorodeoxyglucose-negative para-aortic nodes. Eligible patients will be randomized to undergo either pelvic radiotherapy with chemotherapy (standard-of-care arm) or surgical staging via a minimally invasive extraperitoneal approach followed by tailored radiotherapy with chemotherapy (experimental arm). The primary end point is overall survival. Secondary end points are disease-free survival, short- and long-term morbidity with pre-therapeutic surgical staging, and determination of anatomic locations of metastatic para-aortic nodes in relationship to the inferior mesenteric artery. We believe this study will show that tailored chemoradiation after pre-therapeutic surgical staging improves survival as compared with chemoradiation based on PET/CT in women with stages IB2-IVA cervical cancer.

Keywords: Cervix; Laparoscopy; PET/CT; Surgical staging.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Clinical Protocols
  • Disease-Free Survival
  • Female
  • Fluorodeoxyglucose F18
  • Humans
  • Lymph Node Excision / methods*
  • Lymphatic Metastasis / diagnosis*
  • Lymphatic Metastasis / diagnostic imaging
  • Lymphatic Metastasis / pathology
  • Research Design
  • Tomography, Emission-Computed*
  • Uterine Cervical Neoplasms / diagnostic imaging
  • Uterine Cervical Neoplasms / pathology
  • Uterine Cervical Neoplasms / surgery*

Substances

  • Fluorodeoxyglucose F18