Comparing surgical methods for endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to estimate recurrence-free survival rates in women with endometrial cancer by comparing selective surgical staging to sentinel node surgical staging. It will gather data to determine the most effective approach for evaluating lymph nodes during surgery. Participants will undergo complete hysterectomy and bilateral salpingooophorectomy with pelvic and aortic lymphadenectomy. The study will assess the outcomes of these surgical techniques to improve treatment strategies for endometrial cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Rachel Miller, M.D. — University of Kentucky
• Study coordinator: Rachel Miller
• Email: raware00@uky.edu
• Phone: 859-323-2169

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.