Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04276532 |
Other study ID # |
V01 2019-12 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 13, 2020 |
Est. completion date |
February 12, 2028 |
Study information
Verified date |
April 2024 |
Source |
Fudan University |
Contact |
Xiaojun Chen, Ph.D |
Phone |
862163455050 |
Email |
cxjlhjj[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Rationale The diagnostic value of sentinel lymph node sampling has been widely approved. NCCN
guideline suggested that "SLN mapping can be considered for the surgical staging of apparent
uterine-confined malignancy when there is no metastasis demonstrated by imaging studies or no
obvious extrauterine disease at exploration". However, the role of SLN in the prognosis of
mid-high risk endometrial cancer clinically confined to the uterus is unclear. There are big
concerns that SLN sampling only without lymph node dissection might miss isolated para-aortic
lymph node metastasis or remain lymph node with metastasis other than SLN unremoved and thus
affect the prognosis of patients. NCCN also suggested that "Para-aortic nodal evaluation from
the inframesenteric and infraenal regions may also be utilized for staging in women with
high-risk tumors such as deeply invasive lesions, high-grade histology, and tumors of serous
carcinoma, clear cell carcinoma or carcinosarcoma. Thus, it is necessary to carry out a
randomized trail to investigate the role of SLN in the prognosis of middle-high risk
endometrial cancer obviously confined to the uterus before surgery.
Ethnics This study were approved by the Ethics Committees of Obstetrics and Gynecology
Hospital of Fudan University and all other institutes. Before initiation of study procedures,
written informed consent will be obtained from each patient regarding risks of treatments and
agreement of using their clinical data for research purpose.
Randomization and Treatment This is a multicentered, open-label, randomized clinical trial.
Randomization will be carried out in each center. A computer-based procedure of simple
randomization (SPSS for Mac, version 22.0; IBM ) will be used for participant enrollment and
randomization. Before an individual is successfully enrolled, her treatment assignment will
remain concealed. This trial will be open label: patients and study physicians were aware of
treatment assignment.
Eligible patients in each center will be randomly assigned (1:1) to receive:
1. Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic
lymphonodectomy (PLN) with para-aortic sampling, or 2. 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.
4. Postoperative adjuvant treatments are carried out following the latest NCCN guidelines
according to doctors' choice.
Statistical analyses On the basis of data from previous studies (GOG249, FRACOGYN), the
2-year PFS is expected to be 88% in the PLN group and 87% in SLN group. SLN would be
considered as inferior to PLN if the 2-year PFS in SLN group is higher than 80%. 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 lost follow up rate ≤10% . Analyses will be done firstly by
intention to treat.