Could less surgery be better for endometrial cancer?
NCT ID NCT02658565
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether doctors can safely remove fewer lymph nodes during surgery for endometrial cancer by using a quick lab test during the operation. The goal is to reduce side effects like pain and swelling while still catching cancer that has spread. About 400 women with endometrial cancer will take part, and researchers will track how well they do over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lymphadenectomy (surgical removal of lymph nodes)
- What this could lead to
- If successful, this could show that a tailored surgical approach is safe and effective, potentially reducing unnecessary lymph node removal and its side effects for many women.
- What could go wrong
- This is an observational validation study, not a randomized trial, so results may not prove cause and effect. The approach may not work for all patients or could miss cancer spread.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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401 people
The number who actually took part.
- Started
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Jan 2016
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 must have signed an approved informed consent and HIPAA authorization. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Kentucky
Lexington, Kentucky, 40506, United States
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Other studies related to the condition(s) this trial covers.
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