Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer

Recruiting now · Not applicable

Conditions studied: Endometrial Cancer

In brief

Through this clinical trial, the investigators aim to verify the usefulness and stability of sentinel lymph node mapping in endometrial cancer of clinical stage I-II.

Key facts

Study ID

NCT04845828

Run by

Asan Medical Center

People needed

810

Starts

2022-01-26

Expected to finish

2029-12-01

Last updated by the study team

2022-02-21

Who can join

Age: 20 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 20 \~ 80 years old female
• histologically diagnosed endometrial cancer that has never been treated before.
• histological type :endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type
• histological grade : FIGO grade 1, 2, 3
• Presumed FIGO stage I-II
• Planed for laparoscopic or robotic hystererctomy and lymph adenectomy
• Largest pelvic or para-aortic lymph node diameter = or < 15 mm in short axis on MRI
• ECOG performance status 0-2
• ASA PS 0-2
• WBC ≥ 3,000/mm3, Platelets ≥ 100,000/mm3, Creatinine ≤ 2.0 mg/dL ,Bilirubin ≤ 1.5 x institutional upper limit normal ,SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normal
• A patient who voluntarily signed a document for the study.

You may not qualify if…

• Presumed FIGO stage III-IV
• Neuroendocrine tumor histology
• Other disease involving lymphatic system
• lymphedema of the lower extremity or inguinal area
• previous pelvic or paraaortic lymph node dissection
• previous radiation or concurrent chemoradiation therapy of abdomen or pelvis
• previous chemotherapy due to malignant disease of abdomen or pelvis
• Patients who have had or have been treated for cancer within five years, other than non-melanoma skin cancer, carcinoma in situ of uterine cervix, stomach or bladder
• severe, uncontrolled underlying diseases or underlying disease with complications
• hypersensitivity to indocyanine green
• a pregnant or breast-feeding woman

Where it is running

• Asan Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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