SENTICOL III: International validation study of sentinel node biopsy in early cervical cancer: A GINECO, ENGOT and GCIG study.

TPS5602 Background: Sentinel node biopsy (SLN) is an alternative to pelvic lymphadenectomy (PLN). The false negative rate is < 1%) when “MSKCC Algorithm” is fulfilled. The technique can detect isolated tumor cells (ITC) or micrometastases in 15 – 20 % of N0 patients, reveal SLN in unexpected areas in up 30% of cases and reduce short term lymphatic morbidity. However, the long-term prognosis of SLN negative patients is unknown. In 2014, the GCIG brainstorming on cervical cancer pointed out the need for a validation study, taking survival into account, giving birth to SENTICOL III. Methods: SENTICOL III is an international prospective multicenter randomized trial. We use a « co-primary » objective regarding Disease Free Survival (DFS) and Health Related Quality of Life. The hypothesis is that SLN biopsy alone provides similar DFS and better quality of life. Secondary objectives are outcome of patients with ITC and micrometastases, evaluation of mapping with indocyanine green (ICG), overall survival, recurrence free survival. A cost analysis will be undertaken and a tumor tissue bank will be established. Patients with an early stage cervical cancer defined as FIGO stage Ia1 with lymphovascular invasion to IIa1, maximum diameter ≤40mm on MRI and node negative on imaging will be eligible to participate. SLN biopsy will be performed using isotopic detection +/- blue dye or ICG. SLN of patients with an “optimal” mapping will be analyzed by frozen section. SLN negative patients will be randomized intraoperatively 1:1 to SLN only or SLN + PLN. All SLN will be submitted to ultrastaging (200 microns levels). All centers will follow a quality assurance program to ensure surgical competency and a standardized pathological evaluation 900 patients will be recruited in 3 years, with 4 years of follow-up. (3 years-disease free survival of 85%, with a non-inferiority margin of 5% (80 vs 85%, HR = 1.373), a unilateral alpha error of 5%, and a power of 80%) The trial has started in France, and an international collaboration has been developed through GCIG and ENGOT. (NCT03386734). CHU Besançon is the sponsor for France Clinical trial information: ID-RCB : 2017-A00945-48.