Sentinel Lymph Node Sampling Versus Systematic Pelvic Lymphadenectomy on the Prognosis for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus Before Surgery: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- The 2-year progression-free survival (2-year PFS)
研究概览
简要总结
Aim To investigate the effect of sentinel lymph node (SLN) sampling on the prognosis of patients with middle-high risk endometrial cancer obviously confined to the uterus before surgery.
详细描述
Aim to investigate the effect of sentinel lymph node (SLN) sampling on the prognosis of patients with middle-high risk endometrial cancer obviously confined to the uterus before surgery.
Rationale The diagnostic value of sentinel lymph node sampling has been widely approved. NCCN guideline suggested that "SLN mapping can be considered for the surgical staging of apparent uterine-confined malignancy when there is no metastasis demonstrated by imaging studies or no obvious extrauterine disease at exploration". However, the role of SLN in the prognosis of mid-high risk endometrial cancer clinically confined to the uterus is unclear. There are big concerns that SLN sampling only without lymph node dissection might miss isolated para-aortic lymph node metastasis or remain lymph node with metastasis other than SLN unremoved and thus affect the prognosis of patients. NCCN also suggested that "Para-aortic nodal evaluation from the inframesenteric and infraenal regions may also be utilized for staging in women with high-risk tumors such as deeply invasive lesions, high-grade histology, and tumors of serous carcinoma, clear cell carcinoma or carcinosarcoma. Thus, it is necessary to carry out a randomized trail to investigate the role of SLN in the prognosis of middle-high risk endometrial cancer obviously confined to the uterus before surgery.
Ethics This study were approved by the Ethics Committees of Obstetrics and Gynecology Hospital of Fudan University and all other institutes. Before initiation of study procedures, written informed consent will be obtained from each patient regarding risks of treatments and agreement of using their clinical data for research purpose.
Randomization and Treatment This is a multicentered, open-label, randomized clinical trial. Randomization will be carried out in each center. A computer-based procedure of simple randomization (SPSS for Mac, version 22.0; IBM ) will be used for participant enrollment and randomization. Before an individual is successfully enrolled, her treatment assignment will remain concealed. This trial will be open label: patients and study physicians were aware of treatment assignment.
Eligible patients in each center will be randomly assigned (1:1) to receive:
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years old;
- •Clinically diagnosed (by pre-surgical pathology and radiology) as primary endometrial cancer confined to uterus with middle-high risk factors:
- •disease limited to the uterus on image study (MRI, CT or ultrasound);
- •including all histological types of endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma, and undifferentiated carcinoma); not including uterine sarcoma
- •excluding low-risk endometrial cancer (endometrioid G 1-2 with pre-surgical endometrial lesion≤2cm and myometrial invasion <50%);
- •with one or more middle-high risk factors including: endometrioid endometrial cancer G3, myometrial invasion ≥50%, tumor size≥2cm, type II endometrial cancer, molecular classification of p53abn, LVSI;
- •diagnosis should be confirmed by at least two senior clinicians;
- •Be able to undergo staging surgery.
排除标准
- •During pregnancy or perinatal period;
- •With synchronous malignancies or other malignancies than endometrial cancer in 3 years, except for non-melanoma skin cancer;
- •With history of important organs transplantation;
- •With immune diseases requiring taking immunosuppressants
- •With severe mental illness or brain function disorders
- •With history of drug abuse;
- •Allergic to contrast agent;
- •Still participating in other clinical trials;
- •Not willing to accept surgery or trial protocol;
- •Not eligible for surgery;
- •Had hysterectomy, chemotherapy, radiotherapy, or hormone therapy before the trail;
- •Had retroperitoneum lymph node dissection for other reasons.
研究组 & 干预措施
Sentinel lymph node sampling
Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN)
干预措施: sentinel lymph node sampling (SLN) (Procedure)
Pelvic lymphadenectomy
Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling
干预措施: pelvic lymphonodectomy (PLN) (Procedure)
结局指标
主要结局
The 2-year progression-free survival (2-year PFS)
时间窗: 2 years
The percentage of patients who have first relapse within 2 years after surgery (SLN or LND)
次要结局
- The 5-year PFS(5 years)
- The 5-year overall survival (OS)(5 years)
- Adverse effect and quality of life (QOL)(Adverse effect: during the surgery, 30 days after surgery; QQL: 1 month before surgery, 6 months, 12 months after surgery)
研究者
Xiaojun Chen
Vice President of Obstetrics and Gynecology Hospital of Fudan University
Fudan University