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

Rachel Miller

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Procedure: REFLEX; Procedure: Selective surgical staging

Study type: Interventional

Funder types: Other

Identifiers

NCT06677112

98450

Details and patient eligibility

About

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.

Enrollment: 625 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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625 participants in 2 patient groups

Selective Surgical Staging with side-specific lymphadenectomy (LAD)

Experimental group

Description:

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

Treatment:

Procedure: Selective surgical staging

REFLEX side-specific LAD

Active Comparator group

Description:

Sentinel node procedure

Treatment:

Procedure: REFLEX