Journal
JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY
Volume 21, Issue 1, Pages 3-8Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jmig.2013.07.007
Keywords
Cervix; Laparoscopy; PET/CT; Surgical staging
Categories
Funding
- NCI NIH HHS [P30 CA016672] Funding Source: Medline
- NATIONAL CANCER INSTITUTE [P30CA016672] Funding Source: NIH RePORTER
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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 RI 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. (C) 2014 AAGL. All rights reserved.
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