NCT06677112Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 625 (estimated)
- First submitted
- 4 Nov 2024
- Start date
- 17 Mar 2025
- Primary completion date
- Jan 2030
- Lead sponsor
- Rachel Miller
- Diseases
- Endometrial cancer
- NCT number
- NCT06677112
What you commit to
- Study type: Interventional
- Planned participants: 625
- From 17 Mar 2025 to the primary completion date, Jan 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous vaginal, pelvic or abdominal irradiation
- 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
Other illness
- Clinical evidence of disease that extends beyond the uterus, including the presence of suspicious aortic or inguinal nodes on imaging or clinical exam
- Chemotherapy or immunotherapy directed at the present disease
- 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
Lab values
- Pregnant or lactating women. Women of child-bearing potential will be excluded if they have a positive serum/urine pregnancy test
Other
- GOG Performance Status greater than 2 (Appendix II)
- Uterine sarcoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.