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Sentinel Lymph Node Mapping for Endometrial Cancer

New Orleans, LA
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
No Placebo-Only Group
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~from enrollment and at 3, 6, 9, 12, and 18 months after surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment and at 3, 6, 9, 12, and 18 months after surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of patient-reported lower extremity limb dysfunction
Secondary study objectives
Rate of perioperative complications
Rate of successful bilateral SLN identification
Rate of successful identification of lymph node metastasis
+2 more
Other study objectives
Adjuvant therapy decisions
Overall survival
Progression free survival
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)Experimental Treatment8 Interventions
Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Group II: Arm 1 (sentinel lymph node mapping)Experimental Treatment8 Interventions
Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~1810
Excisional Biopsy
2017
N/A
~50
Indocyanine Green Solution
2018
N/A
~150
Minimally Invasive Surgery
2010
N/A
~140

Find a Location

Closest Location:University Medical Center New Orleans· New Orleans, LA· 800 miles

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,070 Total Patients Enrolled
5 Trials studying Uterine Corpus Cancer
913 Patients Enrolled for Uterine Corpus Cancer
NRG OncologyLead Sponsor
241 Previous Clinical Trials
104,559 Total Patients Enrolled
1 Trials studying Uterine Corpus Cancer
230 Patients Enrolled for Uterine Corpus Cancer
Edward Tanner, MDPrincipal InvestigatorNRG Oncology
Edward J TannerPrincipal InvestigatorNRG Oncology

Media Library

Minimally Invasive Surgery Clinical Trial Eligibility Overview. Trial Name: NCT05646316 — Phase 3
Uterine Corpus Cancer Research Study Groups: Arm 1 (sentinel lymph node mapping), Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)
Uterine Corpus Cancer Clinical Trial 2023: Minimally Invasive Surgery Highlights & Side Effects. Trial Name: NCT05646316 — Phase 3
Minimally Invasive Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646316 — Phase 3
~88 spots leftby Oct 2025