RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Indocyanine Green Solution for Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

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.

Official registry: https://clinicaltrials.gov/study/NCT05646316 · NRG Oncology · enrollment listed as 428

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Diagnostic Imaging Testing, or Excisional Biopsy. The registry lists allocation as randomized. 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.

They plan to enroll about 428 people at 60 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: Biospecimen Collection, Diagnostic Imaging Testing, Excisional Biopsy, Indocyanine Green Solution, Minimally Invasive Surgery, Pelvic Lymphadenectomy, Questionnaire Administration, Sentinel Lymph Node Mapping

Primary outcome (registry wording): Incidence of patient-reported lower extremity limb dysfunction

Who it is for (from inclusion criteria)

Ages 18 Years to any
Women only
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 how well it works assessment of the investigational regimen are eligible for this trial

Who the registry excludes

Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable
History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
Patients with severe, active co-morbidity defined as follows:
History of patient or provider identified lower extremity lymphedema
History of patient or provider identified chronic lower extremity swelling

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

60 listed

George Washington University Medical Center — Washington D.C., District of Columbia (suspended)
UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida (recruiting)
UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida (recruiting)
UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida (recruiting)
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida (recruiting)
UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida (recruiting)
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida (recruiting)
UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida (recruiting)
Augusta University Medical Center — Augusta, Georgia (recruiting)
Northwestern University — Chicago, Illinois (recruiting)
Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois (recruiting)
IU Health North Hospital — Carmel, Indiana (recruiting)

+ 5 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05646316 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05646316?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05646316?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary