Sentinel Lymph Node Sampling vs. Systematic Pelvic Lymphadenectomy Impact on Middle-High Risk Endometrial Cancer Prognosis
This study compares the impact of Sentinel Lymph Node Sampling and Systematic Pelvic Lymphadenectomy on the 2-year progression-free survival rate in patients with middle-high risk endometrial cancer.
sentinel lymph node sampling (SLN)
+ pelvic lymphonodectomy (PLN)
Treatment Study
Summary
Study start date: February 13, 2020
Actual date on which the first participant was enrolled.This study focuses on women with middle to high-risk endometrial cancer that is contained within the uterus before surgery. The main goal is to understand the impact of a procedure called sentinel lymph node (SLN) sampling on the patient's prognosis. This is important because while the diagnostic value of SLN sampling is recognized, its role in the prognosis of this specific type of cancer is unclear. There are concerns that SLN sampling might overlook certain types of cancer spread, which could affect the patient's outcome. This study aims to clarify these uncertainties and potentially improve care for women with this condition. In this trial, participants will be randomly assigned to one of two groups. One group will receive a total hysterectomy with or without the removal of the ovaries and fallopian tubes, along with pelvic lymph node dissection and para-aortic sampling. The other group will receive the same surgery but with sentinel lymph node sampling instead. The surgery can be performed using different methods, and the use of colored dyes to help identify the sentinel lymph nodes is acceptable. After the surgery, any additional treatments will follow the latest guidelines. The study will monitor the patients for two years, looking at how many patients in each group have a relapse within this timeframe. This will help determine if sentinel lymph node sampling is as effective as the more extensive procedure in terms of preventing cancer progression.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.780 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Older than 18 years old; 2. Clinically diagnosed (by pre-surgical pathology and radiology) as primary endometrial cancer confined to uterus with middle-high risk factors: 1. Disease limited to the uterus on image study (MRI, CT or ultrasound); 2. including all histological types of endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma, and undifferentiated carcinoma); not including uterine sarcoma 3. excluding low-risk endometrial cancer (endometrioid G 1-2 with pre-surgical endometrial lesion≤2cm and myometrial invasion \<50%); 4. with one or more middle-high risk factors including: endometrioid endometrial cancer G3, myometrial invasion ≥50%, tumor size≥2cm, type II endometrial cancer; LVSI 5. diagnosis should be confirmed by at least two senior clinicians. 3. Be able to undergo staging surgery. Exclusion Criteria: 1. During pregnancy or perinatal period; 2. With malignancies other than endometrial cancer; 3. With history of important organs transplantation; 4. With immune diseases requiring taking immunosuppressants 5. With severe mental illness or brain function disorders 6. With history of drug abuse; 7. Allergic to contrast agent; 8. Still participating in other clinical trials; 9. Not willing to accept surgery or trial protocol; 10. Not eligible for surgery; 11. Had hysterectomy, chemotherapy, radiotherapy, or hormone therapy before the trail; 12. Had retroperitoneum lymph node dissection for other reasons.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, ChinaOpen Obstetrics and Gynecology Hospital, Fudan University in Google Maps