International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

SLN biopsy only: In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.

SLN biopsy + PLN dissection: In active comparator arm, SLN dissection + full lymphadenectomy will be performed.

Study summary

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".

Eligibility

Primary outcome measure(s)

• Disease Free Survival (DFS) — Year 3
  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.
• Health-related quality of life (HR-QoL) — Year 3
  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.

Trial sites (106)

+ 66 more sites — see the full list on the official registry below.