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NCT05646316 · ClinicalTrials.gov registry record · Phase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
A Phase 3 study of Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 428
- Enrollment target
- 20
- Study locations
NCT05646316: Recruiting Phase 3 study of Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, sponsored by NRG Oncology.
NCT05646316 is a Phase 3 study of Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 428 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05646316, a Phase 3 study of Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 428 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy. The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire. Surveys will be performed at enrollment (pre-surgery) and at 3, 6,
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Diagnostic Imaging Testing
- PROCEDURE Excisional Biopsy
- DRUG Indocyanine Green Solution
- PROCEDURE Minimally Invasive Surgery
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Louisiana
- West Jefferson Medical Center - Marrero
- East Jefferson General Hospital - Metairie
- LSU Healthcare Network / Metairie Multi-Specialty Clinic - Metairie
- Louisiana State University Health Science Center - New Orleans
- University Medical Center New Orleans - New Orleans
Illinois
- Northwestern University - Chicago
- Northwestern Medicine Cancer Center Warrenville - Warrenville
Indiana
- IU Health North Hospital - Carmel
- Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- UM Upper Chesapeake Medical Center - Bel Air
District of Columbia
- George Washington University Medical Center - Washington D.C.
Georgia
- Augusta University Medical Center - Augusta
Michigan
- Wayne State University/Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2022-12-07 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 3 |
What NCT05646316 shows while recruiting
NCT05646316 is an interventional study that assigns participants to a tested intervention. The registered 428 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05646316 names 20 study sites across 8 states, led by Florida, Louisiana, Illinois.
Frequently Asked Questions
What is clinical trial NCT05646316 about?
NCT05646316 is a clinical study titled "Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer". 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 uter...
What is the current status of trial NCT05646316?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 428 participants. The study started on 2022-12-07. Estimated completion is 2026-10-31.
What conditions does trial NCT05646316 study?
This clinical trial studies the following conditions: Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8.
What interventions are being tested in trial NCT05646316?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Diagnostic Imaging Testing (PROCEDURE), Excisional Biopsy (PROCEDURE), Indocyanine Green Solution (DRUG), Minimally Invasive Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05646316?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05646316 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05646316's enrollment target sits among peer trials
428 879th of 2000 higher than 1,121 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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