Clinical trial NCT02990728: Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer
Official title: Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer.Mirena®
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective To discover the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin, as fertility-preserving treatment for grade 1 endometrioid adenocarcinoma of endometrium, cT1aN0M0 with presumed no myometrial invasion on image study (MRI preferred).

Secondary objectives

1. To discover the morphological and molecular change in the endometrium tumor before and after treatment
2. To discover the effectiveness of adding oral progestin to subjects who show no good response to assigned
3. To compare (1) the systemic effects, including body weight change, neuropsychiatric alternation, GI disturbance, skin disorder, change in serum metabolic and hepatic markers between the two study patient groups; (2) The rate of long-term success defined as (a) sustained remission of \>= 12 months starts from the histologic documentation of complete remission (b) rate of pregnancy and (c) alive baby delivery, based on time-to-event analysis.
4. Molecular markers and their expression before, during and after treatment, including progesterone B receptor, progesterone A receptor, estrogen receptor, Ki67, PTEN and its related markers, Bcl2 and its related markers and other developing markers. This is to discover prediction markers to medical treatment.


Eligibility criteria: Inclusion Criteria:

1. Women \<= 40 years old with histologic confirmed grade 1 endometrioid adenocarcinoma of the endometrium
2. Tumour is confirmed to the endometrial cavity with no evidence of metastasis on MRI and/or trans-vaginal ultrasonography
3. ECOG 0-1, adequate organ function, with fertility preserving need
4. Immunohistochemical study showed positive progesterone receptor and positive estrogen receptor in the endometrial tumour tissue
5. Serum CA 125 titre is within normal limit
6. Signed informed consent

Exclusion Criteria:

1. Women age \> 40 years or endometrial cancer other than grade 1 endometrioid adenocarcinoma
2. Suspected lymph node metastasis or other metastasis appears in image study
3. Ovarian tumour in image study
4. Blurred junction between the endometrium and the myometrium on image study, with the impression that myometrial invasion of the endometrial tumour cannot be ruled out
5. Ultrasonographic study or MRI show obvious adenomyosis or ovarian endometriosis
6. Women who are contraindicated to receive study treatment because of intolerance to treatment agents, medical co-morbidity or other reason(s)
7. Women with history of or concurrent with malignancy other than skin basal cell carcinoma
8. Women who cannot participate regular follow-up

Primary outcomes:
measure: the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin
timeFrame: the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin about 6 month
Secondary outcomes:
Other outcomes:
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Study officials:
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