Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer

Endometrial Cancer Clinical Trial

— SELYE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04845828
• Other study ID #: KGOG 2029
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: December 1, 2029

Study information

• Verified date: February 2022
• Source: Asan Medical Center
• Contact: Jeong-Yeol Park, M.D Ph.D.,
• Phone: +82-2-3010-3646
• Email: obgyjypark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 20 ~ 80 years old female

2. histologically diagnosed endometrial cancer that has never been treated before.

3. histological type :endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type

4. histological grade : FIGO grade 1, 2, 3

5. Presumed FIGO stage I-II

6. Planed for laparoscopic or robotic hystererctomy and lymph adenectomy

7. Largest pelvic or para-aortic lymph node diameter = or < 15 mm in short axis on MRI

8. ECOG performance status 0-2

9. ASA PS 0-2

10. 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

11. A patient who voluntarily signed a document for the study.

Exclusion Criteria:

1. Presumed FIGO stage III-IV

2. Neuroendocrine tumor histology

3. Other disease involving lymphatic system

4. lymphedema of the lower extremity or inguinal area

5. previous pelvic or paraaortic lymph node dissection

6. previous radiation or concurrent chemoradiation therapy of abdomen or pelvis

7. previous chemotherapy due to malignant disease of abdomen or pelvis

8. 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

9. severe, uncontrolled underlying diseases or underlying disease with complications

10. hypersensitivity to indocyanine green

11. a pregnant or breast-feeding woman

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• Sentinel lymph node mapping
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. 3. Sentinel lymph node is excised
• Routine lymph node dissection
Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy Lymph node detection is performed.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Bae 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. — View Citation

Ballester M, Dubernard G, Lécuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Daraï 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. — View Citation

Lécuru F, Mathevet P, Querleu D, Leblanc E, Morice P, Daraï 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. — View Citation

Tanner 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Secondary	Surgery-related morbidity rate	Compare the surgery-related morbidity rate after one month of surgery.	One month
Secondary	Incidence of lymphocele and lymphedema	After 3 years of surgery, the incidence of lymphocele and lymphedema are compared.	3 years
Secondary	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.	3 years
Secondary	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.	5 years
Secondary	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.	5-years
Secondary	The pattern of recurrence	Anatomic location of first recurrence	3 years