RECRUITING

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

Conditions

Endometrial Cancer selective surgical staging lymphadenectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-17

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06677112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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	* 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, hormone therapy 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

Inclusion Criteria

Exclusion 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.
* 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

* 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, hormone therapy 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

Contacts and Locations

Study Contact

Rachel Miller

CONTACT

859-323-2169

raware00@uky.edu

Principal Investigator

Rachel Miller, M.D.

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

University of Kentucky

Lexington, Kentucky, 40506

United States

Collaborators and Investigators

Sponsor: Rachel Miller

Rachel Miller, M.D., PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17

Study Completion Date2030-01

Study Record Updates

Study Start Date2025-03-17

Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

selective surgical staging
lymphadenectomy

Additional Relevant MeSH Terms

Endometrial Cancer