Int J Gynecol Cancer. 2025 Nov 21:102821. doi: 10.1016/j.ijgc.2025.102821. Online ahead of print.
ABSTRACT
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.
PMID:41763980 | DOI:10.1016/j.ijgc.2025.102821
