This phase III trial compares the effectiveness of selective surgical staging versus reflex side specific lymphadenectomy (LAD) in evaluating sentinel lymph nodes in non-mappers undergoing surgery for endometrial cancer. Standard surgical treatment for endometrial cancer is a removal of the uterus, ovaries and fallopian tubes, and possible lymph node removal (lymphadenectomy). Currently there is no standard approach on the extent of lymph node removal or whether it is necessary. Often, the individual surgeon determines the extent of the surgical treatment rather than using criteria that relate to the extent of the disease and risk factors. Mapping the sentinel lymph node, the first lymph node affected by cancer spread, is used to detect lymph node disease prior to surgery. However, sentinel lymph node mapping may not completely identify all lymph nodes, and it is suggested that high-risk patients may benefit from LAD even with negative mapping. Selective surgical staging involves the inspection of the uterus and pelvis by the surgeon and the pathologist during surgery to determine whether the cancer has spread and if removal of lymph nodes is needed. Reflex side-specific LAD relies on the results of the lymph node mapping to determine lymph node removal. Selective surgical staging with side-specific LAD as indicated, may be as effective as reflex side-specific LAD in non-mappers undergoing surgery for endometrial cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06677112.
Locations matching your search criteria
United States
Kentucky
Lexington
University of Kentucky/Markey Cancer CenterStatus: Active
Contact: Rachel Ware Miller
Phone: 859-323-2169
PRIMARY OBJECTIVE:
I. To estimate recurrence-free survival rates in women with endometrial cancer treated with sentinel lymph node sampling in whom non-mapping sides are approached with SELECTIVE SURGICAL STAGING with side-specific lymphadenectomy as indicated versus REFLEX side-specific lymphadenectomy.
SECONDARY OBJECTIVES:
I. To evaluate frequency and location of mapping in patients undergoing cervical injection for sentinel lymph node sampling for surgical staging of endometrial cancer.
II. To compare concordance of SELECTIVE SURGICAL STAGING with final pathology.
III. To estimate the progression-free, disease-specific, and overall patient survival rates in the study groups up to 5-years from study enrollment.
IV. To assess patterns of nodal involvement associated with staging procedures, disease stage, and histological characteristics.
V. To assess patient morbidity (adverse events) and mortality related to the surgical management of endometrial cancer treated with sentinel lymph node sampling in whom non-mapping sides are approached with SELECTIVE SURGICAL STAGING versus REFLEX surgical staging, including operative time, estimated blood loss, length of stay, infection, deep venous thrombosis, and other adverse events.
OUTLINE:
Patients undergo hysterectomy and bilateral salpingo-oophorectomy, and receive indocyanine green (ICG) tracer injection for lymph node mapping. Patients with successful lymph node mapping during surgery undergo LAD for all mapped lymph nodes. Patients with unsuccessful lymph node mapping during surgery are randomized to Arm I or II.
ARM I (SELECTIVE SURGICAL STAGING): Patients undergo an intraoperative consultation (IOC) during surgery to determine risk. Patients may or may not undergo a side specific LAD per result of IOC risk assessment. Patients with unsuccessful mapping of both sides may undergo a complete LAD during surgery.
ARM II (REFLEX SIDE-SPECIFIC LAD): Patients undergo side-specific LAD. Patients with unsuccessful mapping of both sides may undergo a complete LAD during surgery.
After completion of study treatment, patients are followed up at 6, 12, 24, 36, 48 and 60 months.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorRachel Ware Miller
