Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Sta… (NCT05646316) | Clinical Trial Compass
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
United States, South Korea428 participantsStarted 2022-12-07
Plain-language summary
This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration
* Clinical stage I endometrial cancer based on the following diagnostic workup:
* History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
* Patients must speak English, Spanish, or Korean
Exclusion Criteria:
* Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
* History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing sentinel lymph node mapping to other approaches in Stage I endometrial cancer — can you help me understand how the lymph node removal method my surgery would use differs from what's being studied here, and whether that difference matters for my specific diagnosis?
2Since the main thing this trial is measuring is lower extremity limb dysfunction — things like leg swelling or lymphedema — how common is that complication after standard lymph node removal, and is that a real risk I should be weighing for my situation?
3This is a Phase 3 trial, which I understand means it's a later-stage study comparing treatments more directly — does that mean there's already enough safety data that participating wouldn't expose me to significantly more unknown risks than standard surgery?
4Given that I have Stage I disease, which is an earlier stage, would my doctor expect my treatment outcomes to be similar whether or not I joined this trial, or is there a meaningful difference in what I might experience?
5What would my follow-up schedule look like if I enrolled in this trial compared to standard care, and are there extra visits, surveys, or procedures I'd need to commit to that might affect my work or daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of patient-reported lower extremity limb dysfunction
Timeframe: From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months