Back to resultsMirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer
Primary Purpose
Endometrial Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metformin
Mirena®
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial Cancer.Mirena®
Eligibility Criteria
Inclusion Criteria:
- Women <= 40 years old with histologic confirmed grade 1 endometrioid adenocarcinoma of the endometrium
- Tumour is confirmed to the endometrial cavity with no evidence of metastasis on MRI and/or trans-vaginal ultrasonography
- ECOG 0-1, adequate organ function, with fertility preserving need
- Immunohistochemical study showed positive progesterone receptor and positive estrogen receptor in the endometrial tumour tissue
- Serum CA 125 titre is within normal limit
- Signed informed consent
Exclusion Criteria:
- Women age > 40 years or endometrial cancer other than grade 1 endometrioid adenocarcinoma
- Suspected lymph node metastasis or other metastasis appears in image study
- Ovarian tumour in image study
- 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
- Ultrasonographic study or MRI show obvious adenomyosis or ovarian endometriosis
- Women who are contraindicated to receive study treatment because of intolerance to treatment agents, medical co-morbidity or other reason(s)
- Women with history of or concurrent with malignancy other than skin basal cell carcinoma
- Women who cannot participate regular follow-up
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mirena® + metformin
Mirena®
Arm Description
The enrolled patient is allocated to either LNG-IUS only or LNG-IUS + metformin by central randomization with study site allocation. A 90-100 days of continuous treatment before first histologic assessment of treatment response is required. The patient will receive endometrial curettage or hysteroscopic evaluation and resection of suspected lesion after 90-100 days of treatment. Patients with good response to assigned treatment will continue the treatment for another 90-100 days and second histologic assessment will be performed. Patients with poor response to assigned treatment at first assessment will receive additive oral progestin therapy, along with the assigned regimen(s) as, Oral progestin, either medroxyprogesterone acetate 500 mg daily or oral megestrol acetate 160 mg daily After a total of at least 6 months treatment period, the patient with good response at first assessment is suggested to keep the Mirena for maintenance until plan to get pregnant
The enrolled patient is allocated to either LNG-IUS only or LNG-IUS + metformin by central randomization with study site allocation. A 90-100 days of continuous treatment before first histologic assessment of treatment response is required. The patient will receive endometrial curettage or hysteroscopic evaluation and resection of suspected lesion after 90-100 days of treatment. Patients with good response to assigned treatment will continue the treatment for another 90-100 days and second histologic assessment will be performed. Patients with poor response to assigned treatment at first assessment will receive additive oral progestin therapy, along with the assigned regimen(s) as, Oral progestin, either medroxyprogesterone acetate 500 mg daily or oral megestrol acetate 160 mg daily After a total of at least 6 months treatment period, the patient with good response at first assessment is suggested to keep the Mirena for maintenance until plan to get pregnant
Outcomes
Primary Outcome Measures
the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin
Secondary Outcome Measures
Full Information
NCT ID
NCT02990728
First Posted
November 16, 2016
Last Updated
December 8, 2016
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02990728
Brief Title
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
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
To discover the morphological and molecular change in the endometrium tumor before and after treatment
To discover the effectiveness of adding oral progestin to subjects who show no good response to assigned
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial Cancer.Mirena®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mirena® + metformin
Arm Type
Experimental
Arm Description
The enrolled patient is allocated to either LNG-IUS only or LNG-IUS + metformin by central randomization with study site allocation. A 90-100 days of continuous treatment before first histologic assessment of treatment response is required. The patient will receive endometrial curettage or hysteroscopic evaluation and resection of suspected lesion after 90-100 days of treatment. Patients with good response to assigned treatment will continue the treatment for another 90-100 days and second histologic assessment will be performed. Patients with poor response to assigned treatment at first assessment will receive additive oral progestin therapy, along with the assigned regimen(s) as, Oral progestin, either medroxyprogesterone acetate 500 mg daily or oral megestrol acetate 160 mg daily After a total of at least 6 months treatment period, the patient with good response at first assessment is suggested to keep the Mirena for maintenance until plan to get pregnant
Arm Title
Mirena®
Arm Type
Active Comparator
Arm Description
The enrolled patient is allocated to either LNG-IUS only or LNG-IUS + metformin by central randomization with study site allocation. A 90-100 days of continuous treatment before first histologic assessment of treatment response is required. The patient will receive endometrial curettage or hysteroscopic evaluation and resection of suspected lesion after 90-100 days of treatment. Patients with good response to assigned treatment will continue the treatment for another 90-100 days and second histologic assessment will be performed. Patients with poor response to assigned treatment at first assessment will receive additive oral progestin therapy, along with the assigned regimen(s) as, Oral progestin, either medroxyprogesterone acetate 500 mg daily or oral megestrol acetate 160 mg daily After a total of at least 6 months treatment period, the patient with good response at first assessment is suggested to keep the Mirena for maintenance until plan to get pregnant
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
The enrolled patient is allocated to either LNG-IUS only or LNG-IUS + metformin by central randomization with study site allocation. A 90-100 days of continuous treatment before first histologic assessment of treatment response is required. The patient will receive endometrial curettage or hysteroscopic evaluation and resection of suspected lesion after 90-100 days of treatment. Patients with good response to assigned treatment will continue the treatment for another 90-100 days and second histologic assessment will be performed. Patients with poor response to assigned treatment at first assessment will receive additive oral progestin therapy, along with the assigned regimen(s) as, Oral progestin, either medroxyprogesterone acetate 500 mg daily or oral megestrol acetate 160 mg daily After a total of at least 6 months treatment period, the patient with good response at first assessment is suggested to keep the Mirena for maintenance until plan to get pregnant
Intervention Type
Device
Intervention Name(s)
Mirena®
Primary Outcome Measure Information:
Title
the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin
Time Frame
the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin about 6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women <= 40 years old with histologic confirmed grade 1 endometrioid adenocarcinoma of the endometrium
Tumour is confirmed to the endometrial cavity with no evidence of metastasis on MRI and/or trans-vaginal ultrasonography
ECOG 0-1, adequate organ function, with fertility preserving need
Immunohistochemical study showed positive progesterone receptor and positive estrogen receptor in the endometrial tumour tissue
Serum CA 125 titre is within normal limit
Signed informed consent
Exclusion Criteria:
Women age > 40 years or endometrial cancer other than grade 1 endometrioid adenocarcinoma
Suspected lymph node metastasis or other metastasis appears in image study
Ovarian tumour in image study
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
Ultrasonographic study or MRI show obvious adenomyosis or ovarian endometriosis
Women who are contraindicated to receive study treatment because of intolerance to treatment agents, medical co-morbidity or other reason(s)
Women with history of or concurrent with malignancy other than skin basal cell carcinoma
Women who cannot participate regular follow-up
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer
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