Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT05454358
Eligibility Criteria:
Inclusion Criteria:
1. Older than 18 years old;
2. Initial diagnosed with stage I-IV(FIGO2009) endometrial epithelial cancer, regardless of pathological types;
3. Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy and sentinel node biopsy; pelvic lymph node sampling and para-aortic lymph node sampling are optional;
4. Life expectancy of 2 or more years.
5. Confirmed NSMP with intermediate or higher prognostic risk according to post-operative clinical pathological assessment and molecular classification;
1. Intermediate prognostic risk group:
* Stage lB endometrioid + Iow-grade\* + LVSI negative or focal
* Stage IA endometrioid + high-grade\*+ LVSI negative or focal
* Stage IA non-endometrioid (serous, clear cell, undifferentiated carcinoma, carcinosarcoma, mixed) without myometrial invasion
2. High-intermediate prognostic risk group:
* Stage I endometrioid + substantial LVSI, regardless of grade and depth of invasion
* Stage lB endometrioid high-grade\*, regardless of LVSI status
* Stage II
3. High prognostic risk group:
* Stage Ill-IVA with no residual disease
* Stage I-IVA non-endometrioid (serous, clear cell, undifferentiated carcinoma, carcinosarcoma, mixed) with myometrial invasion, and with no residual disease
4. Advanced Metastatic:
* Stage III-IVA with residual disease
* Stage IVB Low grade: G1-2; High grade:G3;
6. Received conventional adjuvant therapy after surgery according to the latest version of NCCN or ESGO/ESTRO/ESP guidelines;
7. Patients with residual tumor after surgery (any single site) must have achieved complete response or partial response after post-operative adjuvant therapy;
8. Expected start of letrozole maintenance within 3 months after adjuvant therapy;
9. Adequate organ function as defined by the following criteria:
* White blood cell (WBC) ≥ 3000/μL or Absolute neutrophil count (ANC) ≥1500/μL
* Platelets ≥100,000/μL
* Serum Aspartate transaminase (AST) and/or serum alanine transaminase (ALT) ≤ 2 times upper limit of normal (ULN)
* Serum creatinine ≤2 times ULN
10. Karnofsky score ≥60;
11. Eastern Cooperative Oncology Group (ECOG) Performance status ≤2;
12. Ability to take anti-thyroid drugs, calcium, vitamin D or bisphosphonates together.
Exclusion Criteria:
1. Endometrial stromal tumor;
2. Recurrent endometrial cancers;
3. Patients with low prognostic risk according to post-operative clinical pathological assessment ( Stage IA endometrioid + low-grade\* +LVSI negative or focal);
4. Patients require no adjuvant therapy after surgery;
5. Negative expression in estrogen receptor or progesterone receptor according to post-operative Immunohistochemistry;
6. Received other adjuvant therapy within 6 months before surgery: including neoadjuvant therapy, hormone therapy, targeted therapy, immunotherapy and biotherapy, etc;
7. Patients with contraindications for letrozole;
8. Patients with other malignant tumors;
9. History of vital organ transplantation;
10. History of immune disease and need to take immunosuppressor;
11. Uncontrolled psychiatric illness or other situations that would limit compliance with study requirements;
12. History of drug abuse;
13. Participated in other clinical trials;
14. No ability or intention to receive letrozole maintenance/sign the consent/obey the study requirements.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05454358
Study Brief:
Protocol Section:
NCT05454358