Status:
RECRUITING
Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
20-80 years
Phase:
NA
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 accur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT04845828
Start Date
January 26 2022
End Date
December 1 2029
Last Update
February 21 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea