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

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.

Author information

1
Department of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: mfrumovitz@mdanderson.org.
2
Department of Surgical Oncology, Claudius Regaud Comprehensive Cancer Center, Toulouse, France.
3
Department of Gynecologic Oncology, Hospital Vall d'Hebron, Barcelona, Spain.
4
Department of Surgery, Institut Gustave Roussy, Paris, France.
5
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
6
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
7
Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
8
Department of Gynecologic Oncology, Oscar Lambret Cancer Center, Lille, France.
9
Department of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

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

PMID:
23911560
PMCID:
PMC4283493
DOI:
10.1016/j.jmig.2013.07.007
[Indexed for MEDLINE]
Free PMC Article

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