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

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 that aims to determine if pretherapeutic laparoscopic surgical staging followed by tailored chemoradiation improves survival compared to PET/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 imaging showing fluorodeoxyglucose (FDG)-avid pelvic nodes and FDG-negative paraaortic nodes. Eligible patients will be randomized to 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 endpoint is overall survival. Secondary endpoints are disease-free survival, short- and long-term morbidity of pretherapeutic surgical staging, and determination of anatomic locations of metastatic paraaortic nodes in relationship to the inferior mesenteric artery. We believe this study will show that tailored chemoradiation after pretherapeutic surgical staging improves survival compared to chemoradiation based on PET/CT in women with stages IB2-IVA cervical cancer.

Perioperative morbidity and rate of upstaging after laparoscopic staging for patients with locally advanced cervical cancer: results of a prospective randomized trial

“…A definitive answer about the value of PET-CT in patients suffering from locally advanced cervical cancer will be provided at the completion of a prospective randomized trial, Lymphadenectomy in Locally Advanced Cervical Cancer Study, which is currently recruiting participants. 29 At present, only surgical staging allows the accurate evaluation of the most important prognostic and therapeutic factors in patients with locally advanced cervical cancer, including peritoneal spread, lymph node involvement, and tumor spread into adjacent organs. 12 Benedetti Panici et al 30 demonstrated a significant association between tumor stage and peritoneal spread in a retrospective study of 162 patients with locally advanced cervical cancer.…”

Lack of Survival Benefit of Para-Aortic Lymphadenectomy in Advanced Cervical Cancer

“…To the author's knowledge, there is no strong evidence at this moment on the survival benefit of the para-aortic lymphadenectomy that increases the survival; however, there are retrospective studies that showed better oncological results in patients who underwent lymphadenectomy compared to patients' assessment with imaging test [2,3].…”

“…Although the Federation of Gynecology and Obstetrics (FIGO) classification [1] does not include the assessment of para-aortic region, the presence of positive para-aortic lymph nodes remains the most important prognostic factor for survival in pa- Hernandez tients with cervical cancer [2,3]. In addition, the presence or absence of lymph node metastases leads to change of the treatment, from primary surgery to chemoradiation therapy.…”

Tailored Radiotherapy Treatment in Advanced Cervical Cancer. Early Experience of Robotics in Surgical Innovation

“…A randomized trial is needed to resolve these questions. The multicenter international study LiLACS (Lymphadenectomy in Locally Advanced Cervical Cancer) directed by Frumovitz at MD Anderson [9], is a phase 3 clinical trial comparing surgical tailored chemoradiation versus PET/CT tailored chemoradiation, with…”