A PHASE III TRIAL OF THE IMPACT OF SENTINEL LYMPH NODE MAPPING ON PATIENT REPORTED LOWER EXTREMITY LIMB DYSFUNCTION IN ENDOMETRIAL CANCER
L
Lisa Landrum, MD, PhD, MS
Primary Investigator
Enrolling By Invitation
18-100 years
Female
Phase
3
10 participants needed
2 Locations
Brief description of study
What is this study about?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What is involved in this study?
Patients are randomized to 1 of 2 arms:
After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.
- ARM 1: Patients receive ICG dye via injection and undergo sentinel lymph node mapping during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping cannot be completed. Successful mapping requires no additional removal of lymph nodes.
- ARM 2: Patients receive ICG dye via injection and undergo sentinel lymph node mapping during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.
After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Stage I Uterine Corpus Cancer AJCC v8
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Age: Between 18 Years - 100 Years
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Gender: Female
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
- 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 or Spanish
Updated on
01 Aug 2024.
Study ID: CTO-NRG-CC010, 20357
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