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).
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
De Vitis Luigi A, Bogani Giorgio, Raspagliesi Francesco, Arencibia Sanchez Octavio, Navarro Beatriz, Multinu Francesco, Zanagnolo Vanna, Baiocchi Glauco, De Brot Louise, Fanfani Francesco, Capasso Ilaria, Piedimonte Sabrina, DeGuerke Lara, Buda Alessandro, Mauro Jessica, Alessio Manuela, Filipello Federica, Beiner Mario, Kadan Yfat, Papadia Andrea, Vizzielli Giuseppe, Restaino Stefano, Grassi Tommaso, Landoni Fabio, Bianchi Tommaso, Grimm Christoph, Polterauer Stephan, Ricotta Giulio, Martinez Alejandra, Buderath Paul, Kimmig Rainer, Chiantera Vito, Zand Behrouz, Zapardiel Ignacio, Hernandez Alicia, Gill Stephanie, Covens Allan, Dagher Christian, Meschini Tommaso, Cucinella Giuseppe, Schivardi Gabriella, Occhiali Tommaso, Lembo Antonio, Palmieri Emilia, Shahi Maryam, Fought Angela J, McGree Michaela E, Suman Vera J, Abu-Rustum Nadeem R, Ramirez Pedro T, Mariani Andrea, Glaser Gretchen E, Low Volume Metastasis in Endometrial Cancer Consortium
Аннотация
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.