Prospective Randomized Comparison of Sentinel Lymph Node Mapping Using Indocyanine Green and Conventional Pelvic Lymph Node Dissection in Clinical Stage I-II Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 810
- 试验地点
- 2
- 主要终点
- The 3-year disease-free survival (3-year DFS)
研究概览
简要总结
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.
详细描述
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 accurate staging and adjuvant therapy group, but it has never been proven to have therapeutic effects by itself. According to the results of two recent randomized clinical trials, routine pelvic lymph node dissection in early stage endometrial cancer doesn't improve survival rates.
Routine pelvic lymph node detection can cause complications in a large number of patients and is associated with poor quality of life. Therefore, it is important to develop a method that can check the status of the lymph node in a less invasive way. Efforts have been made to preserve other lymph nodes with significantly less potential for metastasis through less invasive methods, reducing lymph edema and complications such as bleeding and nerve damage caused by excessive surgery.
Sentinel lymph node dissection is used as a standard treatment for breast cancer and malignant melanoma, and efforts to develop it have recently continued in endometrial cancer and cervical cancer. A SENTICOL study conducted in cervical cancer patients showed a false-negative rate of 0% when both were monitored lymph node dissection. In addition, unlike routine pelvic lymph node dissection, ultra-staging through 0,2mm gas intercepts allow additional detection of less than 2mm of microtransfer or less than 0.2mm of independent tumor cells that have not been found before. In a recent large-scale prospective study of endometrial cancer, sentinel lymph node mapping using indocyanine green and fluorescent imaging was successful at 86%, and sensitivity (patient-by-patient analysis) reported 100% in diagnosis of lymph node metastasis.
As laparoscopic and robotic surgery account for most of the treatment of endometrial cancer patients, a good environment is created for monitoring lymph node exploration using ICG, and sensitivity and detection rate seem to have improved compared to the previous method. However, there has been no prospective study on the effects of patient clinical prognosis, such as a standard treatment, pelvic lymph node resection, and disease-free survival rate, and overall survival rate, so a prospective study is essential. The investigators compare survival rates in the group that does sentinel lymph node mapping and routine pelvic lymph node detection in endometrial cancer in clinical stage I-II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
结局指标
主要结局
The 3-year disease-free survival (3-year DFS)
时间窗: 3 years
The time interval between the date of surgery and the date of recurrence will be caculated as month. The survival curve will be calculated suing Kaplan-Meir method, and survival difference will be compared using Log-rank test.
次要结局
- The pattern of recurrence(3 years)
- Surgery-related morbidity rate(One month)
- The 5-year overall survival (5-year OS)(5-years)
- Incidence of lymphocele and lymphedema(3 years)
- The 5-year disease free survival (5-year DFS)(5 years)
- The 3-year overall survival (3-year OS)(3 years)
研究者
Jeong-Yeol Park, MD, PhD
Professor
Asan Medical Center