Clinical trial NCT04972682: [SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer
Official title: Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Endometrial Neoplasms
Endometrial Adenocarcinoma
Endometrial Cancer Stage I
Endometrial Cancer Stage II
Endometrial Endometrioid Adenocarcinoma
Sentinel Lymph Node
Hysterectomy
Laparoscopic Hysterectomy
Keywords: Endometrial Cancer
Endometrial Adenocarcinoma
Sentinel Lymph Node Biopsy
Laparoscopic Hysterectomy
Adjuvant Therapy
FIGO
Lead sponsor: Moscow City Oncology Hospital No. 62
Sponsor class: OTHER_GOV
First posted: 2021-07-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-center prospective open-label single-arm clinical trial
Primary purpose: TREATMENT

Brief summary: While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
* FIGO stage IA
* FIGO stage IB and II when LND is contraindicated
* No contraindications for surgery
* Signed informed consent

Exclusion Criteria:

* • Age \<18 years
* Presence of tumor spread outside the corpus uteri
* Absence of tumor invasion into the myometrium
* High-grade tumor (G3)
* Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
* Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy
* Prior pelvic or retroperitoneal LND
* History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization
* Allergy to iodine-containing drugs
* Contraindications to surgical treatment
* Lack of signed informed consent

Primary outcomes:
measure: Change in postoperative treatment strategy
timeFrame: Up to 3 weeks after surgery
Secondary outcomes:
measure: Adjustments in FIGO staging
timeFrame: Up to 3 weeks after surgery
measure: Bilateral SLN detection
timeFrame: At the end of the surgery - 1 day
measure: Details of intraoperative complications of SLN biopsy
timeFrame: At the end of the surgery - 1 day
measure: The rate of intraoperative complications of SLN biopsy
timeFrame: At the end of the surgery - 1 day
measure: Major postoperative morbidity
timeFrame: Up to 30 days after surgery
measure: Postoperative mortality
timeFrame: Up to 30 days after surgery
measure: Incidence of lymphedema
timeFrame: Up to 24 months after surgery
measure: Pelvic recurrence rate
timeFrame: 24 months after surgery
measure: Time to pelvic recurrence
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: Istra
country: Russian Federation
facility: 1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62
state: Moskovskaya Oblast
Study officials:
References:
citation: Sorokin P, Novozhilov M, Utkin D, Abduragimova Z, Dudina I, Nikiforchin A, Kulikova S. Tailoring postoperative management through sentinel lymph node biopsy in low- and intermediate-risk endometrial cancer - the SENTRY clinical trial. Klin Onkol. 2024;38(2):126-133. doi: 10.48095/ccko2024126.