Recruiting NCT06677112
MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selective surgical staging, REFLEX.
- Who it may be relevant to
- Registry conditions: Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Procedure Selective surgical staging
Intraoperative Consultation, performed by pathologist and surgeon jointly. The uterus is inspected for extra-corpus spread (cervix, parametria, adnexa, distant). The surgical pathologist will evaluate the uterus according to the IOC Worksheet and promptly notify the surgeon of the results. The IOC will include evaluation for extra-corpus disease, lesion measurement, frozen section (to confirm measured lesion is malignant, cell type, and re-grading of tumor). Non-sentinel nodes will be handled ac - Procedure REFLEX
The surgeon will perform a side-specific lymphadenectomy when there is no mapping on a hemipelvis (no tracer uptake in nodes). If neither side has successful Sentinel Node mapping, the surgeon performs a complete pelvic lymphadenectomy. Surgeons will remove the para-aortic lymph nodes at their discretion.
Primary outcome measures
- Recurrence free survival [Time frame: up to 5 years]
Secondary outcome measures (4)
- Concordance between selective surgical staging and final pathology Incidence [Time frame: 5 years]
- Progression-free survival [Time frame: up to 5 years]
- Disease-specific Survival [Time frame: up to 5 years]
- Overall patient survival rate [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT06677112 · 98450