Selective Surgical Staging in Predicting Lymph Node Removal in Patients with Endometrial Cancer Undergoing Surgery

Status: closed to accrual and intervention

This clinical trial evaluates selective surgical staging in the treatment of women with early stage endometrial cancer (EC). The standard treatment for women with EC includes the surgical removal of the uterus (hysterectomy), both fallopian tubes and ovaries (bilateral salpingo-oophorectomy), and sometimes the lymph nodes (lymph node sampling). Even though this is a common malignancy, gynecologic oncologists still disagree on the best treatment for early EC. Some surgeons choose not to remove any lymph nodes, some perform lymph node sampling, and others remove all related lymph nodes (lymphadenectomy). Since lymph node removal is associated with adverse events, it should only be performed when necessary. By performing a systematic examination of the uterus after its removal (intraoperative consultation, IOC), doctors can better determine whether or not lymphadenectomy should be performed. Using this treatment strategy, the extent of the surgery is tailored to match the risk that the woman’s lymph nodes will be involved by cancer. After completion of the IOC, women with high-risk cancers are treated with lymphadenectomy while women with low-risk cancers are not.

Inclusion Criteria

All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy
Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation
Preoperative evaluation to rule-out extra-uterine disease may include computed tomography (CT) scan, magnetic resonance imaging (MRI), or ultrasound; preoperative imaging is not mandatory for study enrollment
Patients may have received prior systemic chemotherapy; such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present disease
Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria

Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam
Patients who have received previous vaginal, pelvic, or abdominal irradiation
Patients who received chemotherapy directed at the present disease
Patients who have circumstances that will not permit completion of this study or the required follow-up
Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years
Patients with GOG performance grade of 3 or 4

PRIMARY OBJECTIVES:

I. To estimate recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).

SECONDARY OBJECTIVES:

I. To compare concordance between IOC and final pathology.

II. To estimate the progression-free, disease-specific, and overall patient survival rates in both subgroups.

III. To assess patterns of nodal involvement associated with different disease sites, stages, and histological subtypes.

IV. To assess patient morbidity and mortality related to the surgical management of endometrial cancer with IOC, including operative time, estimated blood loss, length of stay, infection, deep venous thrombosis and other pertinent factors.

OUTLINE:

Patients undergo surgery with IOC. Patients found to be high risk for nodal involvement are treated with lymphadenectomy.

After completion of study treatment, patients are followed up for at least 5 years.

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Selective Surgical Staging in Predicting Lymph Node Removal in Patients with Endometrial Cancer Undergoing Surgery

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