Middle-high Risk Endometrial CancerNCT04276532
Sentinel Lymph Node Sampling for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus
A study testing sentinel lymph node sampling (SLN) and pelvic lymphonodectomy (PLN) in people with Middle-high Risk Endometrial Cancer and Sentinel Lymph Node Sampling, run by Xiaojun Chen at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Middle-high Risk Endometrial Cancer, Sentinel Lymph Node Sampling, Prognosis
- What is being tested?
- sentinel lymph node sampling (SLN) and pelvic lymphonodectomy (PLN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2020to 12 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tenth People's Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200072
About this study
Official title: 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
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.
Read the detailed description
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:
- Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with para-aortic sampling, or 2. Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN).
- The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines.
- Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted.
- Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted.
- Postoperative adjuvant treatments are carried out following the latest NCCN or ESGO guidelines according to doctors' choice.
Statistical analyses On the basis of data from previous studies (GOG249, FRACOGYN), the 2-year PFS is expected to be 88% in the PLN group and 87% in SLN group. SLN would be considered as inferior to PLN if the 2-year PFS in SLN group is higher than 80%. An accrual of 780 patients in 3 years will provide the study with adequate power (80%) to detect a clinically relevant absolute difference of 8% in 2-year PFS (88% vs 80%) between both groups (one-sided test, a=0.025), with a lost follow up rate ≤10% . Analyses will be done firstly by intention to treat.
- Being tested
- sentinel lymph node sampling (SLN), pelvic lymphonodectomy (PLN)
- Keywords
- Middle-high risk endometrial cancer, Sentinel lymph node sampling, Pelvic lymphadenectomy, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel lymph node sampling (SLN)Procedure or surgery
Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN).
- The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines；
- Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted；
- Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted.
pelvic lymphonodectomy (PLN)Procedure or surgery
Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node sampling | Experimental | Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN) Receives: Procedure: sentinel lymph node sampling (SLN) |
| Pelvic lymphadenectomy | Active comparator | Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling Receives: Procedure: pelvic lymphonodectomy (PLN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 2-year progression-free survival (2-year PFS)
The percentage of patients who have first relapse within 2 years after surgery (SLN or LND)
Measured: 2 years
Secondary outcomes (3)
The 5-year PFS
The percentage of patients who have first relapse within 5 years after surgery (SLN or LND)
Measured: 5 years
The 5-year overall survival (OS)
The percentage of patients who die within 5 years after surgery (SLN or LND)
Measured: 5 years
Adverse effect and quality of life (QOL)
The occurence rate of each adverse effects related to surgery (SLN or LND, the scores of each QOL survay
Measured: Adverse effect: during the surgery, 30 days after surgery; QQL: 1 month after surgery, 6 months, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start13 Feb 2020
- Primary completion26 Jan 2027 (estimated)
- Study completion12 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Middle-high Risk Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaojun Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Tongji Hospital, West China Second University Hospital, Sun Yat-Sen University Cancer Center, Chongqing University Cancer Hospital
- Responsible party
- Sponsor-investigator, Xiaojun Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276532
- Sponsor's protocol ID
- V01 2019-12
- Status last verified
- May 2026
- First submitted
- 13 Feb 2020
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guan J, Xue Y, Zang RY, Liu JH, Zhu JQ, Zheng Y, Wang B, Wang HY, Chen XJ. Sentinel lymph Node mapping versus systematic pelvic lymphadenectomy on the prognosis for patients with intermediate-high-risk Endometrial Cancer confined to the uterus before surgery: trial protocol for a non-inferiority randomized controlled trial (SNEC trial). J Gynecol Oncol. 2021 Jul;32(4):e60. doi: 10.3802/jgo.2021.32.e60.
PubMed 34085796
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04276532
- Acronym / sponsor ID
- V01 2019-12
- Keywords
- Middle-high risk endometrial cancer, Sentinel lymph node sampling, Pelvic lymphadenectomy, Prognosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Xiaojun ChenUniversity, hospital or other
- Collaborators
- Fudan University, Tongji Hospital, West China Second University Hospital, Sun Yat-Sen University Cancer Center, Chongqing University Cancer Hospital
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 26 Jan 2027 (estimated)
- Study completion
- 12 Feb 2030 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with para-aortic sampling, or 2. Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN).
- The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines.
- Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted.
- Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted.
- Postoperative adjuvant treatments are carried out following the latest NCCN or ESGO guidelines according to doctors' choice.
Statistical analyses On the basis of data from previous studies (GOG249, FRACOGYN), the 2-year PFS is expected to be 88% in the PLN group and 87% in SLN group. SLN would be considered as inferior to PLN if the 2-year PFS in SLN group is higher than 80%. An accrual of 780 patients in 3 years will provide the study with adequate power (80%) to detect a clinically relevant absolute difference of 8% in 2-year PFS (88% vs 80%) between both groups (one-sided test, a=0.025), with a lost follow up rate ≤10% . Analyses will be done firstly by intention to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node sampling | Experimental | Procedure: sentinel lymph node sampling (SLN)Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN) |
| Pelvic lymphadenectomy | Active comparator | Procedure: pelvic lymphonodectomy (PLN)Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Be able to undergo staging surgery.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sentinel lymph node sampling (SLN)Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN). 1. The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines； 2. Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted； 3. Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted. | Procedure or surgery | Sentinel lymph node sampling |
| pelvic lymphonodectomy (PLN)Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling | Procedure or surgery | Pelvic lymphadenectomy |
Primary outcome
The 2-year progression-free survival (2-year PFS)
Time frame: 2 years
The percentage of patients who have first relapse within 2 years after surgery (SLN or LND)
3 secondary outcomes
The 5-year PFS
Time frame: 5 years
The 5-year overall survival (OS)
Time frame: 5 years
Adverse effect and quality of life (QOL)
Time frame: Adverse effect: during the surgery, 30 days after surgery; QQL: 1 month after surgery, 6 months, 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 34085796Guan J, Xue Y, Zang RY, Liu JH, Zhu JQ, Zheng Y, Wang B, Wang HY, Chen XJ. Sentinel lymph Node mapping versus systematic pelvic lymphadenectomy on the prognosis for patients with intermediate-high-risk Endometrial Cancer confined to the uterus before surgery: trial protocol for a non-inferiority randomized controlled trial (SNEC trial). J Gynecol Oncol. 2021 Jul;32(4):e60. doi: 10.3802/jgo.2021.32.e60.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sentinel lymph node sampling (SLN) and pelvic lymphonodectomy (PLN) in people with Middle-high Risk Endometrial Cancer and Sentinel Lymph Node Sampling, run by Xiaojun Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 2-year progression-free survival (2-year PFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.