NCT04845828Recruiting
Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection 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
Source: ClinicalTrials.gov · Last updated 21 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 810 (estimated)
- First submitted
- 12 Apr 2021
- Start date
- 26 Jan 2022
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Asan Medical Center
- Diseases
- Endometrial cancer
- NCT number
- NCT04845828
What you commit to
- Study type: Interventional
- Planned participants: 810
- From 26 Jan 2022 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Other disease involving lymphatic system
- 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
Other
- Presumed FIGO stage III-IV
- Neuroendocrine tumor histology
- lymphedema of the lower extremity or inguinal area
- a pregnant or breast-feeding woman
Who the study is looking for
- 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.
Age in the registry: 20 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.