Sentinel Lymph Node Sampling for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus

NCT04276532 | Active Not Recruiting

• 1 other identifier: V01 2019-12
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Middle-high Risk Endometrial Cancer; Sentinel Lymph Node Sampling; Prognosis

Keywords

Middle-high risk endometrial cancer; Sentinel lymph node sampling; Pelvic lymphadenectomy; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Secondary Outcomes (3)

• The 5-year PFS

  5 years

• The 5-year overall survival (OS)

  5 years

• Adverse effect and quality of life (QOL)

  Adverse effect: during the surgery, 30 days after surgery; QQL: 1 month before surgery, 6 months, 12 months after surgery

Study Arms (2)

Sentinel lymph node sampling

EXPERIMENTAL

Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN)

Procedure: sentinel lymph node sampling (SLN)

Pelvic lymphadenectomy

ACTIVE COMPARATOR

Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with para-aortic sampling

Procedure: pelvic lymphonodectomy (PLN)

Interventions

sentinel lymph node sampling (SLN) PROCEDURE

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.

Sentinel lymph node sampling

pelvic lymphonodectomy (PLN) PROCEDURE

Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with para-aortic sampling

Pelvic lymphadenectomy

Eligibility Criteria

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

You may qualify if:

• 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; LVSI
• diagnosis should be confirmed by at least two senior clinicians.
• Be able to undergo staging surgery.

You may not qualify if:

• During pregnancy or perinatal period;
• With malignancies other than endometrial 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;
• 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.

Sponsors & Collaborators

• Xiaojun Chen: lead
• Fudan University: collaborator
• Tongji Hospital: collaborator
• West China Second University Hospital: collaborator
• Sun Yat-sen University: collaborator
• Chongqing University Cancer Hospital: collaborator

Study Sites (1)

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• 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.

  PMID: 34085796 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of Obstetrics and Gynecology Hospital of Fudan University

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 19, 2020
• Study Start: February 13, 2020
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): February 12, 2030
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CN (1)