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

NCT06677112 | Recruiting DMC

• 1 other identifier: 98450
• Study Type: interventional
• Target: 625
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer

Keywords

selective surgical staging; lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Concordance between selective surgical staging and final pathology Incidence

  5 years

• Progression-free survival

  up to 5 years

• Disease-specific Survival

  up to 5 years

• Overall patient survival rate

  5 years

Other Outcomes (3)

• 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

Study Arms (2)

Selective Surgical Staging with side-specific lymphadenectomy (LAD)

EXPERIMENTAL

Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC).

Procedure: Selective surgical staging

REFLEX side-specific LAD

ACTIVE COMPARATOR

Sentinel node procedure

Procedure: REFLEX

Interventions

Selective surgical staging PROCEDURE

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.

Selective Surgical Staging with side-specific lymphadenectomy (LAD)

REFLEX PROCEDURE

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.

REFLEX side-specific LAD

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rachel Miller: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Reflex

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Neurologic Examination; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rachel Miller, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Miller

CONTACT

859-323-2169; raware00@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)