MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer

Randomized Phase 3 Study of SELECTIVE SURGICAL STAGING Versus REFLEX Lymphadenectomy in Non-mappers Undergoing Sentinel Lymph Node Sampling for the Treatment of Endometrial Cancer

This study aims to estimate the recurrence-free survival rates in women with endometrial cancer treated with selective versus sentinel node surgical staging. This study will gather information to help determine the best way to evaluate lymph nodes during surgery for endometrial cancer.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Procedure: Selective surgical staging; Procedure: REFLEX

• Study Type: Interventional
• Enrollment (Estimated): 625
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Miller; Phone Number: 859-323-2169; Email: raware00@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University Of Kentucky
      • Contact: Rachel Miller, M.D.; Phone Number: 859-323-2169; Email: raware00@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Surgical candidate for complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy
• Histologically or cytologically confirmed carcinoma of the endometrium confined to the uterine corpus
• No clinical evidence of extra-uterine disease on pre-operative evaluation. Preoperative evaluation to rule-out extra-uterine disease may include a CT scan, MRI or ultrasound. Note: preoperative imaging is not mandatory for study enrollment.
• Prior systemic chemotherapy is allowed so long as it was at least five years prior to study enrollment, and there is no evidence of disease after such therapy.

Neoadjuvant chemotherapy for this endometrial cancer is not allowed.

• Life expectancy (estimated survival) of at least 6 months.
• AST(SGOT)/ALT(SGPT) < 3.0X upper limit of normal
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• GOG Performance Status greater than 2 (Appendix II)
• Uterine sarcoma
• Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
• Previous vaginal, pelvic or abdominal irradiation
• Chemotherapy or immunotherapy directed at the present disease
• Previous pelvic lymphadenectomy or retroperitoneal surgery
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen should be excluded
• Known allergy to iodine or indocyanine green (ICG) tracer, or allergic reactions to compounds of similar chemical or biologic composition
• Patients with uncontrolled intercurrent illness
• Patients with psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or lactating women. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective Surgical Staging with side-specific lymphadenectomy (LAD); Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC).	Procedure: Selective surgical staging; Intraoperative Consultation, performed by pathologist and surgeon jointly. The uterus is inspected for extra-corpus spread (cervix, parametria, adnexa, distant). The surgical pathologist will evaluate the uterus according to the IOC Worksheet and promptly notify the surgeon of the results. The IOC will include evaluation for extra-corpus disease, lesion measurement, frozen section (to confirm measured lesion is malignant, cell type, and re-grading of tumor). Non-sentinel nodes will be handled according to institutional standard-of-care practice.
Active Comparator: REFLEX side-specific LAD; Sentinel node procedure	Procedure: REFLEX; The surgeon will perform a side-specific lymphadenectomy when there is no mapping on a hemipelvis (no tracer uptake in nodes). If neither side has successful Sentinel Node mapping, the surgeon performs a complete pelvic lymphadenectomy. Surgeons will remove the para-aortic lymph nodes at their discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence free survival	Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between selective surgical staging and final pathology Incidence	Percentage of participants for whom selective surgical staging and final pathology match	5 years
Progression-free survival	period from study entry until disease progression, death, or date of the last contact	up to 5 years
Disease-specific Survival	period from study entry until death from the disease (endometrial cancer)	up to 5 years
Overall patient survival rate	period from study entry until death from any cause	5 years

Other Outcome Measures

Outcome Measure	Time Frame
Location patterns of nodal involvement associated with staging procedures	5 years
Location patterns of nodal involvement associated with disease stage	5 years
Patterns of nodal involvement associated with histological characteristics	5 years

Collaborators and Investigators

• Sponsor: Rachel Miller
• Investigators: Principal Investigator: Rachel Miller, M.D., University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: lymphadenectomy; selective surgical staging
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Musculoskeletal and Neural Physiological Phenomena; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Physical Examination; Nervous System Physiological Phenomena; Neurologic Examination; Reflex
• Other Study ID Numbers: 98450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No