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

Sponsor
Asan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04845828
Collaborator
(none)
810
Enrollment
1
Location
2
Arms
94.2
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sentinel lymph node mapping
  • Procedure: Routine lymph node dissection
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
810 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Comparison of Sentinel Lymph Node Mapping Using Indocyanine Green and Conventional Pelvic Lymph Node Dissection in Clinical Stage I-II Endometrial Cancer
Actual Study Start Date :
Jan 26, 2022
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sentinel lymph node mapping

The group composed of patients who undergo sentinel lymph node mapping

Procedure: Sentinel lymph node mapping
Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock. 3. Sentinel lymph node is excised
Other Names:
  • Indocyanine green
  • Fluorescent camera

    		•
    Active Comparator: Routine lymph node dissection

    The group composed of patients who undergo routine pelvic lymph node dissection

    Procedure: Routine lymph node dissection
    Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy Lymph node detection is performed.

    Outcome Measures

    Primary Outcome Measures

    1. The 3-year disease-free survival (3-year DFS) [3 years]

      The time interval between the date of surgery and the date of recurrence will be caculated as month. The survival curve will be calculated suing Kaplan-Meir method, and survival difference will be compared using Log-rank test.

    Secondary Outcome Measures

    1. Surgery-related morbidity rate [One month]

      Compare the surgery-related morbidity rate after one month of surgery.

    2. Incidence of lymphocele and lymphedema [3 years]

      After 3 years of surgery, the incidence of lymphocele and lymphedema are compared.

    3. The 3-year overall survival (3-year OS) [3 years]

      The time interval between the date of surgery and the date of death of disease will be caculated as month. The survival curve will be calculated suing Kaplan-Meir method, and survival difference will be compared using Log-rank test.

    4. The 5-year disease free survival (5-year DFS) [5 years]

      The time interval between the date of surgery and the date of recurrence will be caculated as month. The survival curve will be calculated suing Kaplan-Meir method, and survival difference will be compared using Log-rank test.

    5. The 5-year overall survival (5-year OS) [5-years]

      The time interval between the date of surgery and the date of death of disease will be caculated as month. The survival curve will be calculated suing Kaplan-Meir method, and survival difference will be compared using Log-rank test.

    6. The pattern of recurrence [3 years]

      Anatomic location of first recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 20 ~ 80 years old female

    2. histologically diagnosed endometrial cancer that has never been treated before.

    3. histological type :endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type

    4. histological grade : FIGO grade 1, 2, 3

    5. Presumed FIGO stage I-II

    6. Planed for laparoscopic or robotic hystererctomy and lymph adenectomy

    7. Largest pelvic or para-aortic lymph node diameter = or < 15 mm in short axis on MRI

    8. ECOG performance status 0-2

    9. ASA PS 0-2

    10. 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

    11. A patient who voluntarily signed a document for the study.

    Exclusion Criteria:

    1. Presumed FIGO stage III-IV

    2. Neuroendocrine tumor histology

    3. Other disease involving lymphatic system

    4. lymphedema of the lower extremity or inguinal area

    5. previous pelvic or paraaortic lymph node dissection

    6. previous radiation or concurrent chemoradiation therapy of abdomen or pelvis

    7. previous chemotherapy due to malignant disease of abdomen or pelvis

    8. 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

    9. severe, uncontrolled underlying diseases or underlying disease with complications

    10. hypersensitivity to indocyanine green

    11. a pregnant or breast-feeding woman

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jeong-Yeol Park, MD, PhD, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT04845828
    Other Study ID Numbers:
    • KGOG 2029
    First Posted:
    Apr 15, 2021
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jeong-Yeol Park, MD, PhD, Professor, Asan Medical Center
    Sentinel lymph node mapping
    Indocyanine green
    Fluorescent camera
    Lymph node dissection
    Endometrial cancer
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Feb 21, 2022