Endometrial CancerPhase 2NCT01512810
Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer
A Phase 2 study testing Lymphadenectomy in people with Endometrial Cancer, run by Frederick R. Ueland, M.D. at 1 site in United States.
Trial summary
Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. 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?
- Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 26 Aug 2021
- Phase
- Phase 2
- 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
- All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy.
- Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation.
- Preoperative evaluation to rule-out extra-uterine disease may include CT scan, MRI, or ultrasound. Preoperative imaging is not mandatory for study enrollment.
- Patients may have received prior systemic chemotherapy. Such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy. Patients must not have received neoadjuvant chemotherapy for the present disease.
- Patients must have GOG performance status 0, 1, or 2.
- Patients must have an estimated survival greater than or equal to 3 months
- Patients who have met the pre-entry requirements specified in Section 7.0.
- Patients must have signed an approved informed consent and HIPAA authorization.
Who cannot join
- Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam.
- Patients who have received previous vaginal, pelvic, or abdominal irradiation.
- Patients who received chemotherapy directed at the present disease.
- Patients who have circumstances that will not permit completion of this study or the required follow-up.
- Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments.
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years.
- Patients with GOG Performance Grade of 3 or 4.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: Treatment of Endometrial Cancer Utilizing Pathology Intraoperative Consultation to Determine Extent of Surgical Staging
Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.
- Conditions
- Endometrial Cancer
- Being tested
- Lymphadenectomy
- Keywords
- Endometrial, Cancer, 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.
LymphadenectomyProcedure or surgery
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Low-risk for nodal involvement | No intervention | No lymphadenectomy recommended |
| High-risk for nodal involvement | Experimental | Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes Receives: Procedure: Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completion26 Aug 2021
- Study completion26 Aug 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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, M.D., Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512810
- Sponsor's protocol ID
- 11-GYN-130
- Status last verified
- Nov 2021
- First submitted
- 13 Jan 2012
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Endometrial Cancer Utilizing Pathology Intraoperative Consultation to Determine Extent of Surgical Staging
- ClinicalTrials.gov ID
- NCT01512810
- Acronym / sponsor ID
- 11-GYN-130
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial, Cancer, Intraoperative Consultation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Frederick R. Ueland, M.D.University, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 19 Jan 2012 (estimated)
- 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.
Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-risk for nodal involvement | No intervention | –No lymphadenectomy recommended |
| High-risk for nodal involvement | Experimental | Procedure: LymphadenectomyLymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes |
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)
- All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy.
- Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation.
- Preoperative evaluation to rule-out extra-uterine disease may include CT scan, MRI, or ultrasound. Preoperative imaging is not mandatory for study enrollment.
- Patients may have received prior systemic chemotherapy. Such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy. Patients must not have received neoadjuvant chemotherapy for the present disease.
- Patients must have GOG performance status 0, 1, or 2.
Key exclusion criteria (7 listed)
- Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam.
- Patients who have received previous vaginal, pelvic, or abdominal irradiation.
- Patients who received chemotherapy directed at the present disease.
- Patients who have circumstances that will not permit completion of this study or the required follow-up.
- Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments.
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 |
|---|---|---|
| LymphadenectomyLymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes | Procedure or surgery | High-risk for nodal involvement |
Primary outcome
Recurrence-free survival
Time frame: 24 months
Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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, M.D. principal investigator
Lucille P. Markey Cancer Center at 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 2 study testing Lymphadenectomy 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 7 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: finished, as of the sponsor's last update on 24 Nov 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 24 months). 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 24 Nov 2021.