Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II).

BACKGROUND

Pelvic and para-aortic lymphadenectomy remains the standard procedure for nodal staging in apparent early-stage ovarian cancer, but it is associated with considerable morbidity and lacks clear evidence of improving survival. Sentinel lymph node mapping may offer a less invasive alternative while still enabling accurate upstaging in a sub-set of patients with occult lymph node metastasis.

PRIMARY

OBJECTIVE

This study aims to evaluate the negative predictive value of the sentinel lymph node technique for detecting lymphatic metastases in early-stage ovarian cancer compared with systematic pelvic and para-aortic lymphadenectomy (gold standard).

STUDY HYPOTHESIS: The sentinel lymph node technique is non-inferior to systematic lymphadenectomy for detecting lymphatic metastasis.

TRIAL

DESIGN

This is a multi-center phase III clinical trial. Eligible patients with confirmed early-stage ovarian cancer will undergoing sentinel lymph node mapping and a subsequently complete staging surgery, including systematic lymphadenectomy. The concordance between both methods will be analyzed.

MAJOR INCLUSION/EXCLUSION CRITERIA: Inclusion: Women aged ≥18 years, with histologically confirmed epithelial ovarian malignancy in apparent International Federation of Gynecology and Obstetrics I to II stage, planned for staging surgery either at the time of initial surgery (after intra-operative frozen section confirmation) or after a deferred histologic diagnosis.

EXCLUSION: Age <18 years, previous vascular or lymphatic pelvic/aortic surgery, previous lymphoma or abdominopelvic tumors, allergy to Technetium-99m or indocyanine green, pregnancy/lactation.

PRIMARY ENDPOINT: Negative predictive value of the sentinel lymph node technique compared to systematic lymphadenectomy for lymph node metastasis.

SAMPLE SIZE: The planned sample size is 100 patients with negative sentinel lymph node results to ensure adequate statistical power (80%) to detect a negative predictive value for the sentinel lymph node technique above 95%. An interim analysis will be performed once 50% of the recruitment has been reached to adjust the exact total sample size. Recruitment period is estimated at 24 to 36 months in 11 high-volume Spanish centers.

ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING

RESULTS

Patient accrual: November 2025 to November 2028.

FINAL RESULTS EXPECTED: January 2029.

TRIAL REGISTRATION: NCT06963268.