Comparing surgical methods for 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
This study is testing two different surgical methods for women with endometrial cancer to see which one helps them stay cancer-free longer after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 625 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06677112 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with histologically confirmed endometrial cancer who are surgical candidates for complete hysterectomy and lymphadenectomy.
Not a fit: Patients with advanced disease or those who have undergone recent systemic chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that enhance survival rates for patients with endometrial cancer.
How similar studies have performed: Other studies have shown promise in evaluating lymph node staging techniques in endometrial cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lexington, Kentucky
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.