NCT06677112

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 625 (estimated)
• Sponsor: Rachel Miller · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-03-17
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2024-11-06
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States