Endometrial CancerPhase 3NCT04970368
Comparison of Nodal Staging in Endometrial Cancer
A Phase 3 study testing Sentinel node procedure and Selective staging in people with Endometrial Cancer, run by Frederick R. Ueland, M.D. 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. 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?
- Sentinel node procedure and Selective staging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2021to 13 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 endometrioid-type endometrial cancer confined to the uterine corpus
- No clinical evidence of extra-uterine disease on pre-operative evaluation.
- 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.
- Age ≥18 years.
- 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/ECOG Performance Status greater than 2
- Non-endometrioid cell type
- 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, hormone therapy or immunotherapy directed at the present disease
- Previous pelvic lymphadenectomy or retroperitoneal surgery
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- 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
- Known allergy to iodine or indigocyanine 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging 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.
- Conditions
- Endometrial Cancer
- Being tested
- Sentinel node procedure, Selective staging
- Keywords
- Sentinel node, Cancer, Endometrial, Intraoperative Consultation
- Medical subject headings
- Endometrial Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node procedureProcedure or surgery
Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
Selective stagingProcedure or surgery
Intraoperative consultation (IOC)
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Node Surgical Staging | Experimental | Not described Receives: Procedure: Sentinel node procedure |
| Selective Surgical Staging | Experimental | Not described Receives: Procedure: Selective staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival rate
Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Measured: 5 years
Secondary outcomes (6)
Progression-free survival rate
Progress-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Measured: 5 years
Disease-specific survival rate
Disease-specific survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Measured: 5 years
Overall patient survival rate
Overall survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
Measured: 5 years
Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology
Percentage of participants for whom selective surgical staging and final pathology match. Match incorporates grade, lesion size, depth of invasion, and low-risk (no lymphadenectomy) versus high-risk (lymphadenectomy).
Measured: 5 years
Patient morbidity
Measured: 5 years
Patient mortality
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 posted21 Jul 2021
- Study start5 Nov 2021
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Why it stopped: Slow accrual
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederick R. Ueland, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frederick R. Ueland, M.D., University of Kentucky
- Investigators
- Frederick Ueland, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970368
- Sponsor's protocol ID
- MCC-21-GYN-210
- Status last verified
- Jan 2024
- First submitted
- 25 Jun 2021
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 3 Study of Selective Versus Sentinel Node Surgical Staging for the Treatment of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04970368
- Acronym / sponsor ID
- MCC-21-GYN-210
- Conditions
- Endometrial Cancer
- Keywords
- Sentinel node, Cancer, Endometrial, Intraoperative Consultation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Frederick R. Ueland, M.D.University, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 21 Jul 2021 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel Node Surgical Staging | Experimental | Procedure: Sentinel node procedure |
| Selective Surgical Staging | Experimental | Procedure: Selective staging |
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 endometrioid-type endometrial cancer confined to the uterine corpus
- No clinical evidence of extra-uterine disease on pre-operative evaluation.
- 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.
- Age ≥18 years.
Key exclusion criteria (11 listed)
- GOG/ECOG Performance Status greater than 2
- Non-endometrioid cell type
- 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, hormone therapy 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 |
|---|---|---|
| Sentinel node procedureExcision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location | Procedure or surgery | Sentinel Node Surgical Staging |
| Selective stagingIntraoperative consultation (IOC) | Procedure or surgery | Selective Surgical Staging |
Primary outcome
Recurrence-free survival rate
Time frame: 5 years
Recurrence-free survival rate in women with endometrial cancer treated with selective versus sentinel node surgical staging
6 secondary outcomes
Progression-free survival rate
Time frame: 5 years
Disease-specific survival rate
Time frame: 5 years
Overall patient survival rate
Time frame: 5 years
Concordance of SELECTIVE and SENTINEL NODE surgical staging with final pathology
Time frame: 5 years
Patient morbidity
Time frame: 5 years
Patient mortality
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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. This study is not recruiting at the moment.
Frederick Ueland, MD 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 Phase 3 study testing Sentinel node procedure and Selective staging in people with Endometrial Cancer, run by Frederick R. Ueland, M.D. 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival rate (time frame: 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 5 Jan 2024.