For women diagnosed with early-stage ovarian cancer, the surgical burden of standard nodal staging may be disproportionate to its clinical benefit — a tension this trial is designed to resolve. Pelvic and para-aortic lymphadenectomy, the current benchmark procedure, carries meaningful morbidity including lymphedema, vascular injury, and prolonged recovery, yet evidence that it extends survival remains sparse. A less invasive path to equivalent diagnostic accuracy would reshape standard-of-care staging surgery.
The SENTOV II trial is a multi-center phase III clinical trial evaluating whether sentinel lymph node (SLN) mapping achieves non-inferior negative predictive value compared with systematic pelvic and para-aortic lymphadenectomy in women with histologically confirmed FIGO stage I–II epithelial ovarian cancer. Enrolled participants (women aged 18 and older) undergo SLN mapping followed immediately by complete systematic lymphadenectomy, allowing direct concordance analysis between both techniques within the same patient. The primary endpoint targets the technique's ability to correctly rule out occult nodal metastasis — the clinically critical question in early-stage disease.
Sentinel lymph node biopsy is already established in breast cancer and endometrial cancer staging, where it has successfully reduced surgical morbidity without compromising oncologic accuracy. Ovarian cancer has lagged in adopting this approach, partly because lymphatic drainage patterns from the ovary are more variable and complex, traveling via both infundibulopelvic and round ligament routes to pelvic and para-aortic basins. Prior smaller studies, including the original SENTOV pilot, suggested feasibility but were underpowered to confirm non-inferiority. The phase III design here addresses that gap directly. Key limitations to watch: the study population is restricted to apparent early-stage disease, and real-world SLN mapping performance may vary with surgical experience and tracer technique. If the trial confirms non-inferiority, the implications for reducing post-surgical morbidity in this patient population are clinically significant — an incremental but potentially practice-changing step forward.