SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm). There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
989
In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
In active comparator arm, SLN dissection + full lymphadenectomy will be performed.
CHC MontLégia
Liège, Belgium
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Barretos Cancer Hospital
Campo Grande, Brazil
Brazilian National Cancer Institute
Rio de Janeiro, Brazil
AC Camargo Cancer Center - Sao Paulo
São Paulo, Brazil
Hospital Amaral Carvalho de Jaù
Disease Free Survival (DFS)
Composite outcome: the time interval between randomization and recurrence (local/distant) or second cancer or death (all causes), whichever occurs first. This time interval will be analysed concomitantly with HR-QoL scores as a composite outcome.
Time frame: Year 3
Health-related quality of life (HR-QoL)
Composite outcome: significant deterioration will specifically be assessed through 3 targeted dimensions (pain score, global health score and physical functioning scores) in EORTC QLQ-C30 and QLQ-CX24 questionnaires. These scores will be analysed concomitantly with DFS as a composite outcome.
Time frame: Year 3
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São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
CIUSSS de l'Est-de-I'lle-de-Montreal Hopital Maisonneuve-Rosemont (CAHA)
Montreal, Canada
CHUM Centre Hospitalier de l'Université de Montréal
Montreal, Canada
CHU Québec (Hôtel Dieu)
Québec, Canada
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