Endometrial CancerSELYENCT04845828
Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
A study testing Sentinel lymph node mapping and Routine lymph node dissection in people with Endometrial Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Sentinel lymph node mapping and Routine lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jan 2022to 1 Dec 2029
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Jeong-Yeol Park
About this study
Official title: Prospective Randomized Comparison of Sentinel Lymph Node Mapping Using Indocyanine Green and Conventional Pelvic Lymph Node Dissection in Clinical Stage I-II Endometrial Cancer
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.
Read the detailed description
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.
- Conditions
- Endometrial Cancer
- Being tested
- Sentinel lymph node mapping, Routine lymph node dissection
- Keywords
- Sentinel lymph node mapping, Indocyanine green, Fluorescent camera, Lymph node dissection, Endometrial cancer
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node mappingProcedure or surgery
Also called Indocyanine green, Fluorescent camera
Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock.
- Sentinel lymph node is excised
Routine lymph node dissectionProcedure or surgery
- Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy
- Lymph node detection is performed.
| Study group | Role | What they receive |
|---|---|---|
| Sentinel lymph node mapping | Experimental | The group composed of patients who undergo sentinel lymph node mapping Receives: Procedure: Sentinel lymph node mapping |
| Routine lymph node dissection | Active comparator | The group composed of patients who undergo routine pelvic lymph node dissection Receives: Procedure: Routine lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 3-year disease-free survival (3-year DFS)
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.
Measured: 3 years
Secondary outcomes (6)
Surgery-related morbidity rate
Compare the surgery-related morbidity rate after one month of surgery.
Measured: One month
Incidence of lymphocele and lymphedema
After 3 years of surgery, the incidence of lymphocele and lymphedema are compared.
Measured: 3 years
The 3-year overall survival (3-year OS)
The time interval between the date of surgery and the date of death of disease 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.
Measured: 3 years
The 5-year disease free survival (5-year DFS)
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.
Measured: 5 years
The 5-year overall survival (5-year OS)
The time interval between the date of surgery and the date of death of disease 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.
Measured: 5-years
The pattern of recurrence
Anatomic location of first recurrence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start26 Jan 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Yeol Park, MD, PhD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845828
- Sponsor's protocol ID
- KGOG 2029
- Acronym
- SELYE
- Status last verified
- Feb 2022
- First submitted
- 12 Apr 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lecuru F, Mathevet P, Querleu D, Leblanc E, Morice P, Darai E, Marret H, Magaud L, Gillaizeau F, Chatellier G, Dargent D. Bilateral negative sentinel nodes accurately predict absence of lymph node metastasis in early cervical cancer: results of the SENTICOL study. J Clin Oncol. 2011 May 1;29(13):1686-91. doi: 10.1200/JCO.2010.32.0432. Epub 2011 Mar 28.
PubMed 21444878Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.
PubMed 21489874Bae HS, Lim MC, Lee JS, Lee Y, Nam BH, Seo SS, Kang S, Chung SH, Kim JY, Park SY. Postoperative Lower Extremity Edema in Patients with Primary Endometrial Cancer. Ann Surg Oncol. 2016 Jan;23(1):186-95. doi: 10.1245/s10434-015-4613-1. Epub 2015 May 19.
PubMed 25986870Tanner EJ, Sinno AK, Stone RL, Levinson KL, Long KC, Fader AN. Factors associated with successful bilateral sentinel lymph node mapping in endometrial cancer. Gynecol Oncol. 2015 Sep;138(3):542-7. doi: 10.1016/j.ygyno.2015.06.024. Epub 2015 Jun 19.
PubMed 26095896Park JY, Kim JH, Baek MH, Park E, Kim SW. Randomized comparison between sentinel lymph node mapping using indocyanine green plus a fluorescent camera versus lymph node dissection in clinical stage I-II endometrial cancer: a Korean Gynecologic Oncology Group trial (KGOG2029/SELYE). J Gynecol Oncol. 2022 Nov;33(6):e73. doi: 10.3802/jgo.2022.33.e73. Epub 2022 Jul 25.
PubMed 36047376
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Sentinel Lymph Node Mapping Using Indocyanine Green and Conventional Pelvic Lymph Node Dissection in Clinical Stage I-II Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04845828
- Acronym / sponsor ID
- SELYE / KGOG 2029
- Conditions
- Endometrial Cancer
- Keywords
- Sentinel lymph node mapping, Indocyanine green, Fluorescent camera, Lymph node dissection, Endometrial cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 15 Apr 2021 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel lymph node mapping | Experimental | Procedure: Sentinel lymph node mappingThe group composed of patients who undergo sentinel lymph node mapping |
| Routine lymph node dissection | Active comparator | Procedure: Routine lymph node dissectionThe group composed of patients who undergo routine pelvic lymph node dissection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 mappingAlso: Indocyanine green, Fluorescent cameraLaparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock. 3. Sentinel lymph node is excised | Procedure or surgery | Sentinel lymph node mapping |
| Routine lymph node dissection1. Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Lymph node detection is performed. | Procedure or surgery | Routine lymph node dissection |
Primary outcome
The 3-year disease-free survival (3-year DFS)
Time frame: 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.
6 secondary outcomes
Surgery-related morbidity rate
Time frame: One month
Incidence of lymphocele and lymphedema
Time frame: 3 years
The 3-year overall survival (3-year OS)
Time frame: 3 years
The 5-year disease free survival (5-year DFS)
Time frame: 5 years
The 5-year overall survival (5-year OS)
Time frame: 5-years
The pattern of recurrence
Time frame: 3 years
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 21 Feb 2022.
- Background: PubMed 21444878Lecuru F, Mathevet P, Querleu D, Leblanc E, Morice P, Darai E, Marret H, Magaud L, Gillaizeau F, Chatellier G, Dargent D. Bilateral negative sentinel nodes accurately predict absence of lymph node metastasis in early cervical cancer: results of the SENTICOL study. J Clin Oncol. 2011 May 1;29(13):1686-91. doi: 10.1200/JCO.2010.32.0432. Epub 2011 Mar 28.
- Background: PubMed 21489874Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.
- Background: PubMed 25986870Bae HS, Lim MC, Lee JS, Lee Y, Nam BH, Seo SS, Kang S, Chung SH, Kim JY, Park SY. Postoperative Lower Extremity Edema in Patients with Primary Endometrial Cancer. Ann Surg Oncol. 2016 Jan;23(1):186-95. doi: 10.1245/s10434-015-4613-1. Epub 2015 May 19.
- Background: PubMed 26095896Tanner EJ, Sinno AK, Stone RL, Levinson KL, Long KC, Fader AN. Factors associated with successful bilateral sentinel lymph node mapping in endometrial cancer. Gynecol Oncol. 2015 Sep;138(3):542-7. doi: 10.1016/j.ygyno.2015.06.024. Epub 2015 Jun 19.
- Derived from this study: PubMed 36047376Park JY, Kim JH, Baek MH, Park E, Kim SW. Randomized comparison between sentinel lymph node mapping using indocyanine green plus a fluorescent camera versus lymph node dissection in clinical stage I-II endometrial cancer: a Korean Gynecologic Oncology Group trial (KGOG2029/SELYE). J Gynecol Oncol. 2022 Nov;33(6):e73. doi: 10.3802/jgo.2022.33.e73. Epub 2022 Jul 25.
- Individual participant dataSharing planned: No
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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.
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 mapping and Routine lymph node dissection in people with Endometrial Cancer, run by Asan Medical Center at 1 site in South Korea.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Feb 2022. 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 South Korea. 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?
Contact Jeong-Yeol Park, M.D Ph.D., (+82-2-3010-3646, obgyjypark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 3-year disease-free survival (3-year DFS) (time frame: 3 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 NCT04845828, which also lists 5 linked publications.
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 21 Feb 2022.