Comparing two methods for lymph node evaluation in early stage endometrial cancer

Prospective Randomized Comparison of Sentinel Lymph Node Mapping Using Indocyanine Green and Conventional Pelvic Lymph Node Dissection in Clinical Stage I-II Endometrial Cancer

This study tests whether a less invasive method called sentinel lymph node mapping is better than the usual lymph node removal for women with early stage endometrial cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 810 (estimated)
• Ages: 20 Years to 80 Years
• Sex: Female
• Sponsor: Asan Medical Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Seoul)
• Trial ID: NCT04845828 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of sentinel lymph node mapping versus routine lymph node dissection in patients with early stage endometrial cancer. The standard treatment involves total hysterectomy and lymph node dissection, but recent studies suggest that routine dissection may not improve survival rates and can lead to complications. By utilizing sentinel lymph node mapping, the study seeks to provide a less invasive alternative that could reduce complications and improve patient quality of life. Participants will be monitored for lymph node status using advanced imaging techniques and surgical methods.

Who should consider this trial

Good fit: Ideal candidates are females aged 20 to 80 with untreated histologically diagnosed endometrial cancer at FIGO stage I-II.

Not a fit: Patients with advanced stage endometrial cancer (FIGO stage III-IV) or those with neuroendocrine tumor histology will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to a safer and more effective method for evaluating lymph nodes in endometrial cancer patients, potentially improving their quality of life.

How similar studies have performed: Previous studies have shown success with sentinel lymph node mapping in other cancers, suggesting potential for similar outcomes in endometrial cancer.

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

Where this trial is running

Seoul

• Asan Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Jeong-Yeol Park, M.D Ph.D.,

Conditions: Endometrial Cancer, Sentinel lymph node mapping, Indocyanine green, Fluorescent camera, Lymph node dissection, Endometrial cancer