Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: A prospective, multi-center, single-arm, observational study (ENDO-ITC study) Journal Article
| Authors: | De Vitis, L. A.; Bogani, G.; Raspagliesi, F.; Arencibia Sanchez, O.; Navarro, B.; Multinu, F.; Zanagnolo, V.; Baiocchi, G.; De Brot, L.; Fanfani, F.; Capasso, I.; Piedimonte, S.; DeGuerke, L.; Buda, A.; Mauro, J.; Alessio, M.; Filipello, F.; Beiner, M.; Kadan, Y.; Papadia, A.; Vizzielli, G.; Restaino, S.; Grassi, T.; Landoni, F.; Bianchi, T.; Grimm, C.; Polterauer, S.; Ricotta, G.; Martinez, A.; Buderath, P.; Kimmig, R.; Chiantera, V.; Zand, B.; Zapardiel, I.; Hernandez, A.; Gill, S.; Covens, A.; Dagher, C.; Meschini, T.; Cucinella, G.; Schivardi, G.; Occhiali, T.; Lembo, A.; Palmieri, E.; Shahi, M.; Fought, A. J.; McGree, M. E.; Suman, V. J.; Abu-Rustum, N. R.; Ramirez, P. T.; Mariani, A.; Glaser, G. E.; Low Volume Metastasis in Endometrial Cancer Consortium |
| Article Title: | Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: A prospective, multi-center, single-arm, observational study (ENDO-ITC study) |
| Abstract: | Background: It is unclear whether isolated tumor cells (ITCs) in sentinel lymph nodes (SLNs) adversely affect prognosis, especially in low-risk endometrial cancer. In a retrospective study, we showed a worse recurrence-free survival for low-risk endometrial cancer with ITCs than the node-negative group. Primary Objective: Our aim is to evaluate whether the likelihood of disease recurrence differs between a prospective cohort of patients with low-risk endometrial cancer with ITCs and an historical cohort with negative SLNs. Study Hypothesis: We hypothesize that patients with low-risk endometrial cancer and ITCs will have a worse recurrence-free survival than patients who are node-negative. Trial Design: This is a prospective, multi-center, single-arm observational study. Consecutive patients with low-risk endometrial cancer with ITCs in the SLNs will be accrued. Observation only will be suggested after surgery. Major Inclusion/Exclusion Criteria: We will include patients with endometrial cancer undergoing pelvic SLN biopsy and ultra-staging with the following characteristics: endometrioid histology, grades 1 to 2, <50% myometrial invasion, without substantial/extensive lympho-vascular space invasion. ITCs in SLNs are defined as tumor cell aggregates ≤0.2 mm or <200 cells. Primary End Point: The primary end point is recurrence-free survival, measured from the date of surgery to the date of recurrence, death, or last disease evaluation. Sample Size: With a sample size of 132 women with low-risk endometrial cancer and ITCs, a 1-sided log-rank test achieves 85% power at a 0.05 significance level to detect an HR of 2.1. The expected number of events during the study is 17.3. Estimated Dates for Completing Accrual and Presenting Results: The study duration will be 60 months: 24 for enrollment and 36 for follow-up. The results are expected in 2029. Trial Registration: ClinicalTrials.gov: NCT06689956. © 2025 European Society of Gynaecological Oncology and the International Gynecologic Cancer Society |
| Keywords: | endometrial cancer; sentinel lymph nodes; isolated tumor cells |
| Journal Title: | International Journal of Gynecological Cancer |
| Volume: | 35 |
| Issue: | 8 |
| ISSN: | 1048-891X |
| Publisher: | Lippincott Williams & Wilkins |
| Publication status: | Published |
| Date Published: | 2025-08-01 |
| Online Publication Date: | 2025-03-07 |
| Start Page: | 101764 |
| Language: | English |
| DOI: | 10.1016/j.ijgc.2025.101764 |
| PROVIDER: | scopus |
| PUBMED: | 40148176 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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