Endometrial CancerPhase 2NCT02990728
Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer
A Phase 2 study testing Metformin and Mirena® in people with Endometrial Cancer, run by Chang Gung Memorial Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Metformin and Mirena®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Endometrial Cancer
- Being tested
- Metformin, Mirena®
- Keywords
- Endometrial Cancer.Mirena®
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
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
Mirena®Device
| Study group | Role | What they receive |
|---|---|---|
| Mirena® + metformin | Experimental | 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 Receives: Drug: Metformin; Device: Mirena® |
| Mirena® | Active comparator | 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 Receives: Device: Mirena® |
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin
Measured: the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin about 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Chang Chang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990728
- Sponsor's protocol ID
- CTC-184
- Status last verified
- Dec 2016
- First submitted
- 16 Nov 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02990728
- Acronym / sponsor ID
- CTC-184
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer.Mirena®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirena® + metformin | Experimental | Drug: Metformin, Device: Mirena®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 |
| Mirena® | Active comparator | Device: Mirena®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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminThe 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 | Drug | Mirena® + metformin |
| Mirena® | Device | Mirena®, Mirena® + metformin |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Mirena® in people with Endometrial Cancer, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.