Endometrial CancerPhase 2NCT01594879
Treatment With Medroxyprogesterone Acetate Plus LNG-IUS in Young Women With Early Stage Endometrial Cancer
A Phase 2 study testing MIrena(LNG-IUS), oral MPA in people with Endometrial Cancer, run by Korean Gynecologic Oncology Group at 1 site in South Korea.
Trial summary
A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone Acetate(MPA) in Young Women with Early Stage Endometrial Cancer. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- MIrena(LNG-IUS), oral MPA
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Dec 2014
- 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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients younger than 40 years
- Patients who are histological confirmed as endometrial adenocarcinoma grade I that is presumably confined to the endometrium based on the MRI evaluation
- Patients who desire to preserve fertility potential
- Patients signed the written informed consent voluntarily
Who cannot join
- Patients who have severe underlying disease or complication
- Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
- Acute liver disease or kidney disease
- Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam CHA medical center
Seoul, Gamnamgu
seok ju Seong, sjseongcheil@yahoo.co.kr
About this study
Official title: Treatment With Medroxyprogesterone Acetate(MPA) Plus Levonorgestrel-releasing Intrauterine System(LNG-IUS) in Young Women With Early Stage Endometrial Cancer: Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2009)
A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone Acetate(MPA) in Young Women with Early Stage Endometrial Cancer.
The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young patients who desire to preserve their potential for fertility may find this standard treatment difficult to accept. Therefore, the conservative treatment for these patients has remained a challenge. A number of studies have reported the effectiveness of hormonal therapy using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma at stage IA, grade 1, who want to maintain reproductive potential. In addition, several recent studies reported the use of LNG-IUS to treat patients at a high risk of perioperative complications who cannot tolerate systemic progesterone because of its adverse effects. Nevertheless, there has been no prospective multicenter trial that investigated the effectiveness of treatment with systemic progesterone in combination with intrauterine progesterone in young women with endometrial cancer.
Read more
Therefore, the investigators conducted a prospective trial of the treatment of the presumably early-stage grade 1 endometrial cancer in young women who desire to preserve fertility by using oral MPA in combination with LNG-IUS.
Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve fertility potential go through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after removal of LNG-IUS.
The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D\&C) procedure.
Read the detailed description
PURPOSE: This prospective study aims to analyze the treatment efficacy of LNG-IUS plus MPA in Young Women with Early Stage Endometrial Cancer and to analyze the diagnostic accuracy of office endometrial aspiration biopsy with LNG-IUS in place compared with dilatation and curettage after removal of LNG-IUS.
ENDPOINTS: The primary endpoints of this study is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D\&C) procedure.
STUDY SETTING AND PROTOCOL REVIEW: This study is a single arm, prospective multi-institutional study. Its protocol was approved by the Institutional Review Board of each clinical trial institution.
PLANNED CLINICAL TRIAL PERIOD: Patient Selection and Enrollment: 24 month after IRB approval of clinical trial Institution.
TREATMENT METHODS: Patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium went through LNG-IUS insertion and were administered MPA at a dosage of 500 mg/day concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with transvaginal ultrasonography, endometrial aspiration biopsy with LNG-IUS in place and D\&C after removal of LNG-IUS. The biopsy findings are compared.
INVESTIGATIONAL PRODUCT
- General Name/Brand name: Mirena - SCHERING Active ingredient: levonorgestrel 52mg Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body.
- General Name/Brand name:Farlutal tab. 500mg/ Pfizer
Active ingredient: Medroxyprogesterone Acetate
PLANNED NUMBER OF SUBJECT 39 patients with biopsy proven grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium.
STATISTICAL CONSIDERATIONS The primary objective of this study is to estimate the treatment efficacy of the oral MPA in combination with LNG-IUS in early stage endometrial cancer in terms of their response rate. The sample size needed for this estimation would be 39 patients after considering 10% of follow-up loss. The Secondary objective is to estimate the consistency of the office endometrial aspiration biopsy and D\&C. Kappa statistics will be used
- Conditions
- Endometrial Cancer
- Being tested
- MIrena(LNG-IUS), oral MPA
- Keywords
- Endometrial cancer, LNG-IUS, oral MPA
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIrena(LNG-IUS), oral MPADevice
Also called Mirena, Farlutal
- General Name/Brand name: Mirena - SCHERING Active ingredient: levonorgestrel 52mg Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body.
- General Name/Brand name:Farlutal tab. 500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate
| Study group | Role | What they receive |
|---|---|---|
| Endometrial cancer, LNG-IUS with MPA | Experimental | Not described Receives: Device: MIrena(LNG-IUS), oral MPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve fertility potential go through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently.
Follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after removal of LNG-IUS.
Measured: 24months after LNG-IUS insertion with taking oral MPA
Secondary outcomes (1)
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D\&C) procedure.
Measured: every 3 month after LNG-IUS insertion with taking oral MPA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Gynecologic Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok Ju Seong, MD, Principal investigator, Gangnam CHA medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594879
- Sponsor's protocol ID
- KGOG2009
- Status last verified
- May 2012
- First submitted
- 7 May 2012
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim MK, Seong SJ, Kang SB, Bae DS, Kim JW, Nam JH, Lim MC, Lee TS, Kim S, Paek J. Six months response rate of combined oral medroxyprogesterone/levonorgestrel-intrauterine system for early-stage endometrial cancer in young women: a Korean Gynecologic-Oncology Group Study. J Gynecol Oncol. 2019 Mar;30(2):e47. doi: 10.3802/jgo.2019.30.e47. Epub 2019 Jan 7.
PubMed 30740964
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Medroxyprogesterone Acetate(MPA) Plus Levonorgestrel-releasing Intrauterine System(LNG-IUS) in Young Women With Early Stage Endometrial Cancer: Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2009)
- ClinicalTrials.gov ID
- NCT01594879
- Acronym / sponsor ID
- KGOG2009
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial cancer, LNG-IUS, oral MPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Korean Gynecologic Oncology GroupUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 May 2012 (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.
A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of Levonorgestrel-releasing intrauterine system (LNG-IUS) plus Medroxyprogesterone Acetate(MPA) in Young Women with Early Stage Endometrial Cancer.
The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. However, young patients who desire to preserve their potential for fertility may find this standard treatment difficult to accept. Therefore, the conservative treatment for these patients has remained a challenge. A number of studies have reported the effectiveness of hormonal therapy using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma at stage IA, grade 1, who want to maintain reproductive potential. In addition, several recent studies reported the use of LNG-IUS to treat patients at a high risk of perioperative complications who cannot tolerate systemic progesterone because of its adverse effects. Nevertheless, there has been no prospective multicenter trial that investigated the effectiveness of treatment with systemic progesterone in combination with intrauterine progesterone in young women with endometrial cancer.
Therefore, the investigators conducted a prospective trial of the treatment of the presumably early-stage grade 1 endometrial cancer in young women who desire to preserve fertility by using oral MPA in combination with LNG-IUS.
Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve fertility potential go through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after removal of LNG-IUS.
The primary endpoint is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D\&C) procedure.
Detailed description
PURPOSE: This prospective study aims to analyze the treatment efficacy of LNG-IUS plus MPA in Young Women with Early Stage Endometrial Cancer and to analyze the diagnostic accuracy of office endometrial aspiration biopsy with LNG-IUS in place compared with dilatation and curettage after removal of LNG-IUS.
ENDPOINTS: The primary endpoints of this study is response rate. Secondary endpoint is to estimate the consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D\&C) procedure.
STUDY SETTING AND PROTOCOL REVIEW: This study is a single arm, prospective multi-institutional study. Its protocol was approved by the Institutional Review Board of each clinical trial institution.
PLANNED CLINICAL TRIAL PERIOD: Patient Selection and Enrollment: 24 month after IRB approval of clinical trial Institution.
TREATMENT METHODS: Patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium went through LNG-IUS insertion and were administered MPA at a dosage of 500 mg/day concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with transvaginal ultrasonography, endometrial aspiration biopsy with LNG-IUS in place and D\&C after removal of LNG-IUS. The biopsy findings are compared.
INVESTIGATIONAL PRODUCT
- General Name/Brand name: Mirena - SCHERING Active ingredient: levonorgestrel 52mg Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body.
- General Name/Brand name:Farlutal tab. 500mg/ Pfizer
Active ingredient: Medroxyprogesterone Acetate
PLANNED NUMBER OF SUBJECT 39 patients with biopsy proven grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium.
STATISTICAL CONSIDERATIONS The primary objective of this study is to estimate the treatment efficacy of the oral MPA in combination with LNG-IUS in early stage endometrial cancer in terms of their response rate. The sample size needed for this estimation would be 39 patients after considering 10% of follow-up loss. The Secondary objective is to estimate the consistency of the office endometrial aspiration biopsy and D\&C. Kappa statistics will be used
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial cancer, LNG-IUS with MPA | Experimental | Device: MIrena(LNG-IUS), oral MPA |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients younger than 40 years
- Patients who are histological confirmed as endometrial adenocarcinoma grade I that is presumably confined to the endometrium based on the MRI evaluation
- Patients who desire to preserve fertility potential
- Patients signed the written informed consent voluntarily
Key exclusion criteria (4 listed)
- Patients who have severe underlying disease or complication
- Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy
- Acute liver disease or kidney disease
- Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker
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 |
|---|---|---|
| MIrena(LNG-IUS), oral MPAAlso: Mirena, Farlutal1. General Name/Brand name: Mirena - SCHERING Active ingredient: levonorgestrel 52mg Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body. 2. General Name/Brand name:Farlutal tab. 500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate | Device | Endometrial cancer, LNG-IUS with MPA |
Primary outcome
response rate
Time frame: 24months after LNG-IUS insertion with taking oral MPA
Young patients with histologically confirmed grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve fertility potential go through LNG-IUS insertion and are administered MPA at a dosage of 500 mg/d concurrently. Follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with LNG-IUS in place and dilatation and curettage after removal of LNG-IUS.
1 secondary outcome
consistency of the results between office endometrial aspiration biopsy and dilatation and curettage (D&C) procedure.
Time frame: every 3 month after LNG-IUS insertion with taking oral MPA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
- Derived from this study: PubMed 30740964Kim MK, Seong SJ, Kang SB, Bae DS, Kim JW, Nam JH, Lim MC, Lee TS, Kim S, Paek J. Six months response rate of combined oral medroxyprogesterone/levonorgestrel-intrauterine system for early-stage endometrial cancer in young women: a Korean Gynecologic-Oncology Group Study. J Gynecol Oncol. 2019 Mar;30(2):e47. doi: 10.3802/jgo.2019.30.e47. Epub 2019 Jan 7.
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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.
Seok Ju Seong, MD principal investigator
Gangnam CHA medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIrena(LNG-IUS), oral MPA in people with Endometrial Cancer, run by Korean Gynecologic Oncology Group at 1 site in South Korea.
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 4 inclusion and 4 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 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 24months after LNG-IUS insertion with taking oral MPA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594879, which also lists 1 linked publication.
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 9 May 2012.