Actively Recruiting
Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
Led by Asan Medical Center · Updated on 2022-02-21
810
Participants Needed
1
Research Sites
409 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 20 to 80 years
- Histologically diagnosed endometrial cancer not previously treated
- Histological types include endometrioid, mucinous, serous, clear cell, undifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed types
- Histological grade of FIGO grade 1, 2, or 3
- Presumed FIGO stage I or II
- Planned laparoscopic or robotic hysterectomy and lymphadenectomy
- Largest pelvic or para-aortic lymph node diameter 15 mm or less on MRI
- ECOG performance status of 0 to 2
- ASA physical status of 0 to 2
- White blood cell count at least 3,000/mm3, platelets at least 100,000/mm3
- Creatinine 2.0 mg/dL or less
- Bilirubin 1.5 times institutional upper limit of normal or less
- SGOT, SGPT, and ALP levels 3 times institutional upper limit of normal or less
- Voluntarily signed a consent document for the study
You will not qualify if you...
- Presumed FIGO stage III or IV
- Neuroendocrine tumor histology
- Other diseases involving the 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 for malignant disease of abdomen or pelvis
- History of cancer treatment within five years except non-melanoma skin cancer, carcinoma in situ of uterine cervix, stomach, or bladder
- Severe or uncontrolled underlying diseases or diseases with complications
- Hypersensitivity to indocyanine green
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
J
Jeong-Yeol Park, M.D Ph.D.,
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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