The SENTIX trial was a prospective observational study that evaluated the safety of sentinel lymph node (SLN) biopsy as a less radical surgical approach for patients with early-stage cervical cancer.

The study aimed to determine whether SLN biopsy was non-inferior to systematic pelvic lymphadenectomy in terms of recurrence rates while reducing postoperative complications such as lower limb lymphedema.

Primary endpoint

Recurrence rate (RR) at 24th month of follow-up

(not counting cervix recurrences after fertility-sparing procedures)

Reference recurrence rate: 7% (at the 24th month follow-up) in patients after systematic pelvic lymphadenectomy.

Margin of non-inferiority: 3%.

Additional endpoints

• Disease-Free Survival

• Pelvic Disease-Free Survival

• Overall Survival

• Prevalence of lower limb lymphedema

• Quality of Life

*Only few relevant examples shown.

Reference recurrence rate

Reference RR was based on historical cohorts of patients (IB1, no LN+ or low proportion of LN+)

• 27 manuscripts

• Data on more than 8700 patients (approx. 100-1400/study)

• RR in the range of 3-29%, median RR between 7%-13%

Sample size: 600

Non-inferiority margin at 24. months: 3%

Power: 90%

Significance: 0.05

Non-inferiority (P0) was determined using a one-sided Z-test.

Study protocol