Clinical trial NCT05565573: Medroxyprogesterone Acetate vs LNG-IUS in Early-stage Endometrioid Carcinoma and Atypical Hyperplasia Patients
Official title: The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Fertility Sparing
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 148
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Advaced studies have confirmed thatfertility preservation therapy has better tumor and pregnancy outcomes in specific patients with early gynecological tumors. Clinically, evidence-based guidelines are urgently needed to guide the screening and treatment of women who are suitable for fertility preservation. Fertility-sparing treatment predominantly involves the use of oral progestins and levonorgestrel-releasing intrauterine devices, which have been shown to be feasible and safe in women with early stage EC and minimal or no myometrial invasion. However, data on the efficacy and safety of conservative management strategies are primarily based on retrospective studies.The present study aims to compared the therapeutic effect of Medroxyprogesterone acetate (MPA) and Levonorgestrel-releasing intrauterine system (LNG-IUS) in early-stage endometrioid carcinoma and atypical hyperplasia patients


Eligibility criteria: Inclusion Criteria:

1. Age ≤ 45 years old;
2. Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma;
3. pelvic augmentation MRI or / and vaginal color ultrasound Doppler examination, tumor confined endometrium;
4. No suspicious metastatic lesions;
5. Endometrial pathological tissue specimens with strong positive expression of estrogen and progesterone receptors;
6. Blood CA125 is normal;
7. no progesterone therapy and contraindications to pregnancy;
8. The patient himself has a strong desire to preserve fertility, and the patient should fully understand that fertility preservation treatment is not the standard treatment method;
9. Conditional acceptance of close follow-up.

Exclusion Criteria:

1. type II endometrial cancer;
2. Patients with abnormal liver and kidney function and other contraindications to progesterone therapy;
3. Other parts of the body are concurrent or successively complicated by other malignant tumors;
4. The patient and his/her family are unable to sign the informed consent form for any reason;
5. Unconditional follow-up.

Primary outcomes:
measure: Complete response rate
timeFrame: 24-week
Secondary outcomes:
measure: Time to achieve complete response
timeFrame: From date of randomization until the date of CR, assessed up to 24 weeks
measure: The pregnancy rate
timeFrame: Up to 2 years after the treatment
measure: The live-birth rate
timeFrame: Up to 2 years after the treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bei Jing Chao-Yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Hua Li, Ph.D
role: STUDY_CHAIR
References: