Endometrial CancerNCT06677112
MCC-24-GYN-11: Comparison of Nodal Sampling in Endometrial Cancer
A study testing Selective surgical staging and REFLEX in people with Endometrial Cancer, run by Rachel Miller at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Selective surgical staging and REFLEX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Rachel Miller, M.D., 859-323-2169, raware00@uky.edu
About this study
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
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.
- Conditions
- Endometrial Cancer
- Being tested
- Selective surgical staging, REFLEX
- Keywords
- selective surgical staging, lymphadenectomy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective surgical stagingProcedure or 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.
REFLEXProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Selective Surgical Staging with side-specific lymphadenectomy (LAD) | Experimental | Pathologist and surgeon jointly perform the Intraoperative Consultation (IOC). Receives: Procedure: Selective surgical staging |
| REFLEX side-specific LAD | Active comparator | Sentinel node procedure Receives: Procedure: REFLEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact
Measured: up to 5 years
Secondary outcomes (4)
Concordance between selective surgical staging and final pathology Incidence
Percentage of participants for whom selective surgical staging and final pathology match
Measured: 5 years
Progression-free survival
period from study entry until disease progression, death, or date of the last contact
Measured: up to 5 years
Disease-specific Survival
period from study entry until death from the disease (endometrial cancer)
Measured: up to 5 years
Overall patient survival rate
period from study entry until death from any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start17 Mar 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rachel Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rachel Miller, University of Kentucky
- Investigators
- Rachel Miller, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677112
- Sponsor's protocol ID
- 98450
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2024
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06677112
- Acronym / sponsor ID
- 98450
- Conditions
- Endometrial Cancer
- Keywords
- selective surgical staging, lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- Rachel MillerUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective Surgical Staging with side-specific lymphadenectomy (LAD) | Experimental | Procedure: Selective surgical stagingPathologist and surgeon jointly perform the Intraoperative Consultation (IOC). |
| REFLEX side-specific LAD | Active comparator | Procedure: REFLEXSentinel node procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective surgical stagingIntraoperative 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. | Procedure or surgery | Selective Surgical Staging with side-specific lymphadenectomy (LAD) |
| REFLEXThe 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. | Procedure or surgery | REFLEX side-specific LAD |
Primary outcome
Recurrence free survival
Time frame: up to 5 years
Participants with no measurable disease from study entry until disease recurrence, death, or date of the last contact
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Miller, M.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective surgical staging and REFLEX in people with Endometrial Cancer, run by Rachel Miller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Miller (859-323-2169, raware00@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.