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

ConditionEndometrial Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorRachel Miller

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Selective surgical staging
Procedure/Surgery
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 according to institutional standard-of-care practice.
REFLEX
Procedure/Surgery
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.

Treatment groups

625 Participants

are divided into 2 treatment groups

Group A: Selective Surgical Staging with side-specific lymphadenectomy (LAD)Experimental treatment 1 intervention

Group B: REFLEX side-specific LADActive comparator 1 intervention

Trial outcomes

Primary outcomes

Recurrence free survival

Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact

Time frame

up to 5 years

Secondary outcomes

Concordance between selective surgical staging and final pathology Incidence

Percentage of participants for whom selective surgical staging and final pathology match

Time frame

5 years

Progression-free survival

period from study entry until disease progression, death, or date of the last contact

Time frame

up to 5 years

Disease-specific Survival

period from study entry until death from the disease (endometrial cancer)

Time frame

up to 5 years

Overall patient survival rate

period from study entry until death from any cause

Time frame

5 years

Other outcomes

Location patterns of nodal involvement associated with staging procedures

Time frame

5 years

Location patterns of nodal involvement associated with disease stage

Time frame

5 years

Patterns of nodal involvement associated with histological characteristics

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rachel Miller

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

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