Unique Protocol ID | SGOG UC1 |
Registration ID | ClinicalTrials.gov Identifier: NCT04276532 |
Protocol Version Number | V03 2022-01 |
IRB ID | 2019-138-C2 |
Data Monitoring Committee: | Yes |
Brief Title: | Sentinel Lymph Node Sampling for Patients With Intermediate-high-Risk Endometrial Cancer Confined to the Uterus |
Official Title： | 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: a non-inferiority randomized controlled trial |
Study Type： | Interventional(Clinical Trial) |
Secondary IDs | SNEC |
Responsible Party： | Shanghai Gynecologic Oncology Group |
Sponsor： | Shanghai Gynecologic Oncology Group |
Collaborators: | Obstetrics and Gynecology Hospital of Fudan University, Fudan University Shanghai Cancer Center, West China Second University Hospital, Sichuan University, Sun Yat-sen University Cancer Center, Zhongshan Hospital of Fudan University, Chongqing University Cancer Hospital, Shanghai First Maternity and Infant Hospital. |
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. |
Study Start Date: | February 13, 2020 |
Primary Completion Date： | January 10, 2025 |
Study Completion Date: | January 10, 2028 |
Study Design: | Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Outcome Measures: | Primary Outcome: · The 2-year progression-free survival (2-year PFS) [ Time Frame: 2 years ] The percentage of patients who have first relapse within 2 years after surgery (SLN or LND) Secondary Outcome: · The 5-year PFS [ Time Frame: 5 years ] The percentage of patients who have first relapse within 5 years after surgery (SLN or LND) · The 5-year overall survival (OS) [ Time Frame: 5 years ] The percentage of patients who die within 5 years after surgery (SLN or LND) · Adverse effect and quality of life (QOL) [ Time Frame: Adverse effect: during the surgery, 30 days after surgery; QQL: 1 month before surgery, 6 months, 12 months after surgery ] The occurence rate of each adverse effects related to surgery (SLN or LND, the scores of each QOL survay |
Keywords: | Middle-high risk endometrial cancer; Sentinel lymph node sampling; Pelvic lymphadenectomy; Prognosis |
Arms: | 1.Experimental: Sentinel lymph node sampling Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN) Interventions: Procedure: sentinel lymph node sampling (SLN) 2.Active Comparator: Pelvic lymphadenectomy Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with para-aortic sampling Intervention: Intervention: Procedure: pelvic lymphonodectomy (PLN) |
Intervention Description: | 1. Procedure: sentinel lymph node sampling (SLN) Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN). The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines； Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted； Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted. 2. Procedure: pelvic lymphonodectomy (PLN) Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with para-aortic sampling |
Inclusion Criteria | 1.Older than 18 years old; 2.Clinically diagnosed (by pre-surgical pathology and radiology) as primary endometrial cancer confined to uterus with middle-high risk factors: a. Disease limited to the uterus on image study (MRI, CT or ultrasound); b. including all histological types of endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma, and undifferentiated carcinoma); not including uterine sarcoma c. excluding low-risk endometrial cancer (endometrioid G 1-2 with pre-surgical endometrial lesion≤2cm and myometrial invasion <50%); d. with one or more middle-high risk factors including: endometrioid endometrial cancer G3, myometrial invasion ≥50%, tumor size≥2cm, type II endometrial cancer; LVSI e. diagnosis should be confirmed by at least two senior clinicians. 3. Be able to undergo staging surgery. |
Exclusion Criteria | 1. During pregnancy or perinatal period; 2. With malignancies other than endometrial cancer; 3. With history of important organs transplantation; 4. With immune diseases requiring taking immunosuppressants 5. With severe mental illness or brain function disorders 6. With history of drug abuse; 7. Allergic to contrast agent; 8. Still participating in other clinical trials; 9. Not willing to accept surgery or trial protocol; 10. Not eligible for surgery; 11. Had hysterectomy, chemotherapy, radiotherapy, or hormone therapy before the trail; 12. Had retroperitoneum lymph node dissection for other reasons. |
Minimum Age: | 18-year-old |
Maximum Age: | 80-year-old |
Accepts Healthy Volunteers: | No |
Sample size | 780 participants |
Sample size consideration | This is a multi-center, open label, non-inferiority randomized controlled trial. On the basis of data from previous studies [19], the 2-year PFS is expected to be 88% in the PLN group and 87% in SLN group. SLN would be considered as non-inferior to PLN if the 2-year PFS in SLN group is higher than 80%. The aim of the trial is to estimate the difference in 2-year PFS with sufficient precision and to exclude a clinically relevant absolute difference in efficacy. An accrual of 780 patients in 3 years will provide the study with adequate power (80%) to detect a clinically relevant absolute difference of 8% in 2-year PFS (88% vs. 80%) between both groups (one-sided test, a=0.025), with a rate of ≤10% including lost follow-up and withdrawal. |
Central Contact： | Xiaojun Chen, Ph.D 862163455050 cxjlhjj@163.comJun Guan, M.D 862163455050 junguan2018@163.com |
Principal Investigators | Xiaojun Chen |
Locations: | Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China, 200011 |
Recruitment Status: | Recruiting |
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