RecruitingNot ApplicableNCT03366051

Sentinel Node Mapping in High Risk Endometrial Cancer

Sentinel Node Mapping Versus Sentinel Node Mapping With Systematic Lymphadenectomy in High Risk Endometrial Cancer: a Open Label, Non-inferiority, Randomized Trial.


Sponsor

AC Camargo Cancer Center

Enrollment

178 participants

Start Date

Dec 22, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the role of systematic lymphadenectomy after sentinel node (SLN) mapping in high risk endometrial cancer (high grade histologies or deep myometrial invasion). The participants will be randomized in a non-inferiority controlled trial in 2 groups: SLN mapping or SLN mapping followed by systematic lymphadenectomy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating a technique called sentinel node mapping — a method to identify the specific lymph nodes most likely to contain cancer cells — in women with high-risk uterine cancer (endometrial cancer), to see if it can accurately replace the more extensive removal of large numbers of lymph nodes. **You may be eligible if...** - You have been diagnosed with a high-grade type of uterine cancer (including grade 3 endometrioid, serous, clear cell, or carcinosarcoma) - You have lower-grade endometrial cancer but with deep invasion into the uterine wall (50% or more) or cancer involving the cervix - You are medically suitable for a full lymph node removal procedure - You have signed informed consent **You may NOT be eligible if...** - You previously had a hysterectomy at a different institution - The cancer has spread outside the uterus (to the abdomen, organs, or lymph nodes) - You previously had pelvic lymph node removal surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESentinel Node Mapping

At least one sentinel node should be retrieved in both hemipelvis. If no sentinel node is found in one hemipelvis, a side specific lymphadenectomy will be performed.

PROCEDURELymphadenectomy

Systematic Pelvic and Para-Aortic Lymphadenectomy


Locations(5)

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Hospital do Cancer de Barretos

Barretos, São Paulo, Brazil

AC Camargo Cancer Center

São Paulo, São Paulo, Brazil

Albert Einstein Hospital

São Paulo, São Paulo, Brazil

Sao Camilo Oncologia

São Paulo, São Paulo, Brazil

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NCT03366051


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