NCT05646316|RecruitingPhase 3DMC

Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer

NRG Oncology ClinicalTrials.gov

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3 other identifiers

NRG-CC010NCI-2022-05090UG1CA189867

Study Type

interventional

Target

428

Locations

1 country

Sites

Timeline

RegisteredDec 2022

StartedDec 2022

CompletionOct 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

428

participants targeted

Target at P50-P75 for phase_3

Timeline

5mo left

Started Dec 2022

Typical duration for phase_3

Geographic Reach

1 country

55 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

Study Progress88%

Dec 2022Oct 2026

First Submitted

Initial submission to the registry

December 2, 2022

Completed

5 days until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

December 2, 2022

Last Update Submit

March 23, 2026

Conditions

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Outcome Measures

Primary Outcomes (1)

Incidence of patient-reported lower extremity limb dysfunction
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, 9, 12, and 18 months post-surgery. Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up. The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors. Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.
From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

Secondary Outcomes (4)

The incidence of lymphedema by quantifiable lower extremity limb changes
From enrollment and at 3, 6, 9, 12, and 18 months after surgery
Rate of successful bilateral SLN identification
At time of surgery
Rate of successful identification of lymph node metastasis
At time of surgery
Rate of perioperative complications
At time of surgery

Other Outcomes (4)

Adjuvant therapy decisions
Up to 24 months
Patient characteristic, extent of lymph node dissection, and adjuvant therapy decisions
Up to 24 months
Progression free survival
The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment
+1 more other outcomes

Study Arms (2)

Arm 1 (sentinel lymph node mapping)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionProcedure: Diagnostic Imaging TestingProcedure: Excisional BiopsyDrug: Indocyanine Green SolutionProcedure: Minimally Invasive SurgeryProcedure: Pelvic LymphadenectomyOther: Questionnaire AdministrationProcedure: Sentinel Lymph Node Mapping

Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)

EXPERIMENTAL

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.