Brief Title
Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
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
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.
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 Type
Interventional
Primary Outcome
The 3-year disease-free survival (3-year DFS)
Secondary Outcome
Surgery-related morbidity rate
Condition
Endometrial Cancer
Intervention
Sentinel lymph node mapping
Study Arms / Comparison Groups
Sentinel lymph node mapping
Description: The group composed of patients who undergo sentinel lymph node mapping
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
810
Start Date
January 26, 2022
Completion Date
December 1, 2029
Primary Completion Date
December 1, 2027
Eligibility Criteria
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
Gender
Female
Ages
20 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
, +82-2-3010-3646, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT04845828
Organization ID
KGOG 2029
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Study Sponsor
, ,
Verification Date
February 2022