دورية أكاديمية
أعرض في EDS

Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial).

التفاصيل البيبلوغرافية
العنوان: Sentinel lymph node mapping versus sentinel lymph node mapping with systematic lymphadenectomy in endometrial cancer: an open-label, non-inferiority, randomized trial (ALICE trial).
المؤلفون: Baiocchi G; Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil glauco.baiocchi@accamargo.org.br., Andrade CEMC; Gynecology Oncology, Barretos Cancer Hospital, Barretos, Brazil., Ribeiro R; Gynecologic Oncology, Erasto Gaertner Hospital, Curitiba, Brazil., Moretti-Marques R; Gynecologic Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil., Tsunoda AT; Gynecologic Oncology, Erasto Gaertner Hospital, Curitiba, Brazil.; PPGTS, Universidade Positivo, Curitiba, Brazil., Alvarenga-Bezerra V; Gynecologic Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil., Lopes A; Gynecology, São Camilo Oncologia, São Paulo, Brazil., Costa RLR; Gynecology, São Camilo Oncologia, São Paulo, Brazil., Kumagai LY; Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil., Badiglian-Filho L; Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil., Faloppa CC; Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil., Mantoan H; Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil., De Brot L; Pathology, AC Camargo Cancer Center, São Paulo, Brazil., Dos Reis R; Gynecology Oncology, Barretos Cancer Hospital, Barretos, Brazil., Goncalves BT; Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil.
المصدر: International journal of gynecological cancer : official journal of the International Gynecological Cancer Society [Int J Gynecol Cancer] 2022 May 03; Vol. 32 (5), pp. 676-679. Date of Electronic Publication: 2022 May 03.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: BMJ Country of Publication: England NLM ID: 9111626 Publication Model: Electronic Cited Medium: Internet ISSN: 1525-1438 (Electronic) Linking ISSN: 1048891X NLM ISO Abbreviation: Int J Gynecol Cancer Subsets: MEDLINE
أسماء مطبوعة: Publication: 2019- : [London] : BMJ
Original Publication: Cambridge, MA, USA : Blackwell Scientific Publications, c1991-
مواضيع طبية MeSH: Endometrial Neoplasms*/surgery , Sentinel Lymph Node*/surgery, Female ; Humans ; Lymph Node Excision ; Prospective Studies ; Quality of Life
مستخلص: Background: Growing evidence suggest that sentinel lymph node (SLN) biopsy in endometrial cancer accurately detects lymph node metastasis. However, prospective randomized trials addressing the oncological outcomes of SLN biopsy in endometrial cancer without lymphadenectomy are lacking.
Primary Objectives: The present study aims to confirm that SLN biopsy without systematic node dissection does not negatively impact oncological outcomes.
Study Hypothesis: We hypothesized that there is no survival benefit in adding systematic lymphadenectomy to sentinel node mapping for endometrial cancer staging. Additionally, we aim to evaluate morbidity and impact in quality of life (QoL) after forgoing systematic lymphadenectomy.
Trial Design: This is a collaborative, multicenter, open-label, non-inferiority, randomized trial. After total hysterectomy, bilateral salpingo-oophorectomy and SLN biopsy, patients will be randomized (1:1) into: (a) no further lymph node dissection or (b) systematic pelvic and para-aortic lymphadenectomy.
Major Inclusion and Exclusion Criteria: Inclusion criteria are patients with high-grade histologies (endometrioid G3, serous, clear cell, and carcinosarcoma), endometrioid G1 or G2 with imaging concerning for myometrial invasion of ≥50% or cervical invasion, clinically suitable to undergo systematic lymphadenectomy.
Primary Endpoints: The primary objective is to compare 3-year disease-free survival and the secondary objectives are 5-year overall survival, morbidity, incidence of lower limb lymphedema, and QoL after SLN mapping ± systematic lymphadenectomy in high-intermediate and high-risk endometrial cancer.
Sample Size: 178 participants will be randomized in this study with an estimated date for completing accrual of December 2024 and presenting results in 2027.
Trial Registration Number: NCT03366051.
Competing Interests: Competing interests: None declared.
(© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
فهرسة مساهمة: Keywords: endometrial neoplasms; postoperative complications; quality of life (pro)/palliative care; sentinel lymph node
سلسلة جزيئية: ClinicalTrials.gov NCT03366051
تواريخ الأحداث: Date Created: 20220303 Date Completed: 20220505 Latest Revision: 20220527
رمز التحديث: 20240628
DOI: 10.1136/ijgc-2022-003378
PMID: 35236752
قاعدة البيانات: MEDLINE
الوصف
تدمد:1525-1438
DOI:10.1136/ijgc-2022-003378