Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation

Not Applicable

Active, not recruiting

• Conditions: Endometrial Cancer
• Interventions: Procedure: Lymphadenectomy

• Registration Number: NCT02658565
• Lead Sponsor: Frederick R. Ueland, M.D.

Brief Summary

Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-20
• Study Start: 2016-01-29
• Primary Completion: 2023-12-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 401

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 CT scan, 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 GOG performance status 0, 1, or 2.
• Patients must have an estimated survival greater than or equal to 3 months
• Patients must have signed an approved informed consent and 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-risk for nodal involvement	Lymphadenectomy	Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	24 months	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 Outcome Measures

Name	Time	Method
Progression-free survival	5 years	Progression-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)
Disease-specific Survival	5 years	Disease-specific survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
Concordance between IOC and final pathology Incidence	5 years
Perioperative morbidity and mortality	5 years	Perioperative morbidity and mortality outcome will be assessed as the number of participants with Adverse Events/death which are related to treatment/surgery .
Overall patient survival	5 years	Overall survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States