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Sentinel Lymph Node Mapping for Endometrial Cancer
Phase 3
Recruiting
Led By Edward Tanner, MD
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment and at 3, 6, 9, 12, and 18 months after surgery.
Awards & highlights
Study Summary
This trial compares sentinel lymph node mapping vs. standard lymph node dissection to reduce risk of leg swelling in patients undergoing hysterectomy for stage I endometrial cancer.
Who is the study for?
This trial is for adults with stage I endometrial cancer who are planning a hysterectomy and lymphatic assessment. They must be in good general health, not have chronic leg swelling or recent infections, radiation, or surgery that could affect the legs or pelvis. Prior cancers are okay if they don't impact this study's safety.Check my eligibility
What is being tested?
The trial compares sentinel lymph node mapping (using dye and camera to find cancer spread) to standard lymph node dissection during hysterectomy in reducing leg swelling risk. It aims to determine which method better predicts long-term limb dysfunction.See study design
What are the potential side effects?
Potential side effects may include reactions to indocyanine green solution used for mapping, complications from minimally invasive surgery such as infection or bleeding, and discomfort from questionnaire administration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment and at 3, 6, 9, 12, and 18 months after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment and at 3, 6, 9, 12, and 18 months after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of patient-reported lower extremity limb dysfunction
Secondary outcome measures
Rate of perioperative complications
Rate of successful bilateral SLN identification
Rate of successful identification of lymph node metastasis
+2 moreOther outcome measures
Adjuvant therapy decisions
Overall survival
Progression free survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)Experimental Treatment6 Interventions
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. Patients also undergo imaging as clinically indicated.
Group II: Arm 1 (sentinel lymph node mapping)Experimental Treatment6 Interventions
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. Patients also undergo imaging as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine Green Solution
2018
N/A
~150
Minimally Invasive Surgery
2010
N/A
~70
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,220 Total Patients Enrolled
6 Trials studying Uterine Corpus Cancer
7,365 Patients Enrolled for Uterine Corpus Cancer
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,424 Total Patients Enrolled
1 Trials studying Uterine Corpus Cancer
230 Patients Enrolled for Uterine Corpus Cancer
Edward Tanner, MDPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a confirmed diagnosis of endometrial cancer and will have surgery including lymph node assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (sentinel lymph node mapping)
- Group 2: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any more opportunities for participants to join this clinical experiment?
"According to clinicaltrials.gov, this research endeavor is still enrolling participants. It was initially published on September 19th 2022 and underwent the latest revision on December 2nd 2022. The study necessitates 428 individuals at a solitary site for completion."
Answered by AI
Has the sentinel lymph node mapping technique attained FDA approval?
"Our team evaluated the safety of Arm 1 (sentinel lymph node mapping) to be a 3 due to existing evidence from Phase 3 trials that suggest it is both efficacious and safe."
Answered by AI
How many participants are recruited for this research?
"Affirmative. On clinicaltrials.gov, it is stated that this research project began recruitment on September 19th 2022 and was recently updated December 2nd of the same year. The aim is to gather 428 study participants from a single medical site."
Answered by AI
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