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Comparison of Nodal Sampling in Endometrial Cancer

This study is looking at the best way to check lymph nodes during surgery for endometrial cancer. It compares two surgical methods: selective surgical staging, where doctors carefully check the uterus and surrounding areas, and REFLEX, which involves removing lymph nodes if initial mapping doesn't work. The goal is to see which method leads to a longer time without the cancer returning (recurrence-free survival) for women with endometrial cancer that is still contained within the uterus. You may be able to join if you are a woman aged 18 or older, need a complete hysterectomy and removal of ovaries and fallopian tubes, and your endometrial cancer is confirmed and hasn't spread outside the uterus. The study is currently unclear about its recruitment status.

Study design
This interventional study plans to include 625 women with endometrial cancer. It compares two different surgical approaches for checking lymph nodes.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to see how long they remain recurrence-free after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06677112

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

Recruiting
NAAges 18+InterventionalTreatment
Rachel Miller
~625 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Selective surgical stagingREFLEX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence free survival
Measured over up to 5 years

Conditions

Endometrial Cancer

Explore related trials

Endometrial Carcinoma

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

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

Who to contact

Rachel Miller
[email protected]
859-323-2169
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Recurrence free survivalup to 5 years

    Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact