Endometrial Cancer, Atypical Endometrial Hyperplasia
Conditions
Brief summary
Primary end points: This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome. Second end points: To analyze the appearances of side-effects.
Interventions
DRUGProgesterone
MPA oral 250mg-500mg qd for 3 months per cycle
DEVICEMirena®
levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle
DRUGGnRH agonist
GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle
Sponsors
West China Second University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No
Inclusion criteria
For Patients With Endometrial Cancer： Inclusion Criteria: * ≤40 years of age: * Having a strong desire for fertility preservation; * Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry; * Disease limited to the endometrium (stage 1A) on MRI; * Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary); * Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.
Exclusion criteria
* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs; * Patients have lynch syndrome (LS); * Patients have contraindications for pregnancy; * Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible); * Patients refuse to participate in clinical follow-up or sign the informed consent form. For Patients With Endometrial atypical hyperplasia： Inclusion Criteria: * ≤ 40 years of age * Having a strong desire for fertility preservation * Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists * Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Response | 6-12 months | Pathologic response to medicine treatment is categorized as complete response (CR), partial response (PR), no change (NC), and progressive disease (PD). CR is defined as the absence of any hyperplastic or cancerous lesion. PR is defined as the residual lesion with degeneration and atrophy of endometrial glands. NC is defined as residual lesion without degeneration or atrophy of endometrial glands. PD is defined as the appearance of endometrial cancer for EAH and grade 2 (G2) or 3 for EC. |
| Pregnancy Rate | 7-144 months | The percentage of successful pregnancies in the CR patients. |
| Live Birth Rate | 16-144 months | The percentage of successfully alive baby delivery in the pregnant patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side-Affects Rate | 1-144 months | The appearances of side-effects include weight gain, irregular vaginal bleeding, breast pain, appetite changes, nausea, vomiting, rash, jaundice, thromboembolism, hypertension, liver dysfunction, kidney dysfunction, glucose intolerance, and diabetes. |
Countries
China
Contacts
Primary ContactZHENG Ying, Professor
Backup ContactCHEN Si Jing, postgraduate
Outcome results
None listed