title: 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 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.
authors.affiliation: Department of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: mfrumovitz@mdanderson.org.
authors.forename: Michael
authors.initials: M
authors.lastname: Frumovitz
authors.affiliation: Department of Surgical Oncology, Claudius Regaud Comprehensive Cancer Center, Toulouse, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Querleu
authors.affiliation: Department of Gynecologic Oncology, Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Gil-Moreno
authors.affiliation: Department of Surgery, Institut Gustave Roussy, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Morice
authors.affiliation: Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Anuja
authors.initials: A
authors.lastname: Jhingran
authors.affiliation: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Mark F
authors.initials: MF
authors.lastname: Munsell
authors.affiliation: Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Homer A
authors.initials: HA
authors.lastname: Macapinlac
authors.affiliation: Department of Gynecologic Oncology, Oscar Lambret Cancer Center, Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Leblanc
authors.affiliation: Department of Surgical Oncology, Claudius Regaud Comprehensive Cancer Center, Toulouse, France.
authors.forename: Alejandra
authors.initials: A
authors.lastname: Martinez
authors.affiliation: Department of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Pedro T
authors.initials: PT
authors.lastname: Ramirez
mesh_terms: D002985:Clinical Protocols; D018572:Disease-Free Survival; D005260:Female; D019788:Fluorodeoxyglucose F18; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods*; D008207:Lymphatic Metastasis / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000473:pathology; D012107:Research Design; D014055:Tomography, Emission-Computed; D002583:Uterine Cervical Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*
chemical_list: D019788:Fluorodeoxyglucose F18
keywords: Cervix; Laparoscopy; PET/CT; Surgical staging
references.citation: Int J Gynecol Cancer. 2012 Sep;22(7):1203-7
references.pmid: 22810967
references.citation: Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1015-23
references.pmid: 9869224
references.citation: N Engl J Med. 1999 Apr 15;340(15):1137-43
references.pmid: 10202164
references.citation: Gynecol Oncol. 2004 Feb;92(2):525-9
references.pmid: 14766243
references.citation: Eur J Nucl Med Mol Imaging. 2010 Jan;37(1):181-200
references.pmid: 19915839
references.citation: Oncologist. 2011;16(7):1021-7
references.pmid: 21659610
references.citation: J Clin Oncol. 2004 Mar 1;22(5):872-80
references.pmid: 14990643
references.citation: Gynecol Oncol. 2010 Dec;119(3):422-5
references.pmid: 20837355
references.citation: Gynecol Oncol. 2012 May;125(2):312-4
references.pmid: 22333995
references.citation: Gynecol Oncol. 2005 May;97(2):468-75
references.pmid: 15863146
references.citation: Cancer. 2011 May 1;117(9):1928-34
references.pmid: 21509770
references.citation: JAMA. 1995 Aug 2;274(5):387-93
references.pmid: 7616634
references.citation: Gynecol Oncol. 2007 May;105(2):304-11
references.pmid: 17258799
references.citation: Gynecol Oncol. 2005 Dec;99(3):536-44
references.pmid: 16126259
references.citation: Cancer. 2000 Apr 15;88(8):1883-91
references.pmid: 10760766
references.citation: Int J Gynecol Cancer. 2010 Nov;20(8):1300
references.pmid: 21051965
references.citation: Gynecol Oncol. 2005 Apr;97(1):183-91
references.pmid: 15790456
references.citation: Gynecol Oncol. 1999 Sep;74(3):436-42
references.pmid: 10479506
references.citation: JAMA. 1997 Oct 1;278(13):1096-101
references.pmid: 9315770
references.citation: Gynecol Oncol. 2010 Oct;119(1):76-80
references.pmid: 20667586
references.citation: Gynecol Oncol. 1988 Jun;30(2):209-15
references.pmid: 3371746
references.citation: J Nucl Med. 2006 May;47(5):885-95
references.pmid: 16644760