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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2029
  • participants needed
    810
  • sponsor
    Asan Medical Center
Updated on 12 March 2022
cancer
hysterectomy
uterine disease
adenocarcinoma
carcinosarcoma

Summary

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.

Description

The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. Pelvic lymph node dissection helps to set accurate staging and adjuvant therapy group, but it has never been proven to have therapeutic effects by itself. According to the results of two recent randomized clinical trials, routine pelvic lymph node dissection in early stage endometrial cancer doesn't improve survival rates.

Routine pelvic lymph node detection can cause complications in a large number of patients and is associated with poor quality of life. Therefore, it is important to develop a method that can check the status of the lymph node in a less invasive way. Efforts have been made to preserve other lymph nodes with significantly less potential for metastasis through less invasive methods, reducing lymph edema and complications such as bleeding and nerve damage caused by excessive surgery.

Sentinel lymph node dissection is used as a standard treatment for breast cancer and malignant melanoma, and efforts to develop it have recently continued in endometrial cancer and cervical cancer. A SENTICOL study conducted in cervical cancer patients showed a false-negative rate of 0% when both were monitored lymph node dissection. In addition, unlike routine pelvic lymph node dissection, ultra-staging through 0,2mm gas intercepts allow additional detection of less than 2mm of microtransfer or less than 0.2mm of independent tumor cells that have not been found before. In a recent large-scale prospective study of endometrial cancer, sentinel lymph node mapping using indocyanine green and fluorescent imaging was successful at 86%, and sensitivity (patient-by-patient analysis) reported 100% in diagnosis of lymph node metastasis.

As laparoscopic and robotic surgery account for most of the treatment of endometrial cancer patients, a good environment is created for monitoring lymph node exploration using ICG, and sensitivity and detection rate seem to have improved compared to the previous method. However, there has been no prospective study on the effects of patient clinical prognosis, such as a standard treatment, pelvic lymph node resection, and disease-free survival rate, and overall survival rate, so a prospective study is essential. The investigators compare survival rates in the group that does sentinel lymph node mapping and routine pelvic lymph node detection in endometrial cancer in clinical stage I-II.

Details
Condition Endometrial Cancer
Treatment Sentinel lymph node mapping, Routine lymph node dissection
Clinical Study IdentifierNCT04845828
SponsorAsan Medical Center
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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