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

NCT04845828 | Recruiting DMC

• 1 other identifier: KGOG 2029
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Cancer

Keywords

Sentinel lymph node mapping; Indocyanine green; Fluorescent camera; Lymph node dissection; Endometrial cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Surgery-related morbidity rate

  One month

• Incidence of lymphocele and lymphedema

  3 years

• The 3-year overall survival (3-year OS)

  3 years

• The 5-year disease free survival (5-year DFS)

  5 years

• The 5-year overall survival (5-year OS)

  5-years

Study Arms (2)

Sentinel lymph node mapping

EXPERIMENTAL

The group composed of patients who undergo sentinel lymph node mapping

Procedure: Sentinel lymph node mapping

Routine lymph node dissection

ACTIVE COMPARATOR

The group composed of patients who undergo routine pelvic lymph node dissection

Procedure: Routine lymph node dissection

Interventions

Sentinel lymph node mapping PROCEDURE

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

Also known as: Indocyanine green, Fluorescent camera

Sentinel lymph node mapping

Routine lymph node dissection PROCEDURE

1. Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Lymph node detection is performed.

Routine lymph node dissection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~ 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Publications (5)

• 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.

  PMID: 21444878 BACKGROUND

• Ballester 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.

  PMID: 21489874 BACKGROUND

• 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.

  PMID: 25986870 BACKGROUND

• 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.

  PMID: 26095896 BACKGROUND

• Park 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.

  PMID: 36047376 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jeong-Yeol Park, M.D Ph.D.,

CONTACT

+82-2-3010-3646; obgyjypark@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: January 26, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)