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New treatment option for Endometrial Cancer
Official title Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
ClinicalTrials.gov ID: NCT04845828
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80, women only
You may be able to join if
- 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...
- histological grade : FIGO grade 1, 2, 3
- Presumed FIGO stage I-II
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.