Carcinoma, EndometrioidNCT06468215
Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer
A study testing Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d. in people with Carcinoma, Endometrioid and Fertility Preservation, run by Peking University People's Hospital at 1 site in China.
Trial summary
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Read more about this study
- Who is it for?
- Ages Up to 45 years, women only
- Conditions the study is for
- Carcinoma, Endometrioid, Fertility Preservation
- What is being tested?
- Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Endometrioid adenocarcinoma G2, diagnosis by pathological.
- The lesion is limited to the endometrium.
- FIGO (2009) staging is IA.
- Age less than 45.
- Strongly request to preserve fertility.
- Sign informed consent.
Who cannot join
- The tumor has invaded the muscle layer.
- FIGO (2009) stage IB or higher.
- Endometrioid adenocarcinoma G1, G3, or non-endometrioid cancer
- There are malignant tumors in other systems.
- Have contraindications for conservative treatment or drug use.
- Have been judged by the researcher to be unsuitable for childbearing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yiqin Wang, 008688324380, emily_wang92@163.com
Jianliu Wang, PhD, MD
About this study
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Fertility-sparing therapies (FST) are gaining popularity for early-stage, low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes. However, consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 (G2) endometrioid adenocarcinoma remains elusive. Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer, this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2.
Read the detailed description
This study aims to explore effective treatment options and pregnancy outcomes for G2 EC patients who wish to preserve their fertility. It compares the efficacy of monotherapy with progesterone versus combined therapy to determine the best treatment option.
This study is a multi-center, prospective, randomized controlled trial that collects hospital and outpatient records of uterine endometrioid adenocarcinoma patients who undergo fertility-sparing treatment at 10 units from October 2022. The basic items specified in the study are registered.
Selection criteria: Pathological diagnosis of endometrioid adenocarcinoma G2, MRI or ultrasound confirmed localization of the lesion within the endometrium, FIGO (FIGO, 2009) staging IA, age ≤ 45 years, and those who wish to preserve reproductive function, signed informed consent. Exclusion criteria: Tumor invasion of the muscle layer, FIGO (FIGO, 2009) staging IB or higher, tumor differentiation as G1, G3, or non-endometrioid adenocarcinoma, coexistence of malignant tumors in other sites, contraindications or drug prohibitions for conservative treatment, or judged by the investigator to be unsuitable for childbearing. Exclusion criteria: Violation of the treatment protocol; failure to take medication as prescribed, affecting the judgment of drug efficacy; incomplete data affecting the judgment of efficacy and safety. Withdrawal criteria: Intolerance of the used drugs or the appearance of serious complications, including venous or arterial thromboembolism, liver failure, renal failure, anaphylaxis, uterine perforation, etc.; no response to treatment or disease progression during drug therapy; when the patient requests termination of treatment.
Treatment Plan: The treatment plan was randomly divided into two groups. Group 1 was a single-drug treatment plan, with oral medroxyprogesterone acetate (MPA) 500mg/d or megestrol acetate (MA) 320mg/d; Group 2 was a combined treatment plan, with oral MPA 500mg/d/MA 320mg/d combined with the placement of levonorgestrel intrauterine system (LNG-IUS) in the uterus.
Since the treatment began, each 3-6 months is a course. At the end of each course, an endometrial biopsy is performed under hysteroscopy to conduct tissue pathological examination and evaluate the treatment effect. A vaginal color Doppler ultrasound is performed every month, and a pelvic MRI is re-evaluated as needed. Additionally, a side effect assessment is performed for each course, including weight, vaginal bleeding, breast discomfort, gastrointestinal symptoms, liver and kidney function, and thrombosis.
The efficacy assessment is divided into the following categories: (1) Complete Response (CR), (2) Partial Response (PR), (3) Disease Unresponsive or Stable Disease (NC/SD), (4) Disease Progression (PD), and (5) Relapse.
The main measurement indicator is the time required for the first complete remission. The secondary measurement indicators are the one-year complete remission rate, the two-year disease recurrence rate, the cumulative pregnancy rate, pregnancy duration, pregnancy outcomes, changes in serum indicators, and pathological markers.
- Conditions
- Carcinoma, Endometrioid, Fertility Preservation
- Being tested
- Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.
- Keywords
- endometrial cancer, fertility-sparing treatment, grade 2
- Medical subject headings
- Carcinoma, Endometrioid, Endometrial Neoplasms, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.Drug
Also called Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD).
Compare the efficacy of mono-therapy with progesterone versus combined therapy to determine the best treatment option.
| Study group | Role | What they receive |
|---|---|---|
| Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients | Experimental | Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d. Receives: Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d. |
| The Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients | Experimental | Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD). Receives: Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Time Required for Complete Remission for the First Time
The time from the diagnosis of G2 endometrioid carcinoma to the first complete remission after fertility-preserving treatment.（year）
Measured: 5 years
Secondary outcomes (4)
One-year complete remission rate
The percentage of patients who achieved complete remission after one year of fertility preservation treatment.
Measured: 5 years
two-year disease recurrence rate
The probability of recurrence within 2 years for patients who underwent treatment for preserving fertility and achieved complete remission.
Measured: 5 years
cumulative pregnancy rate
The percentage of pregnancies that occurred during the observation period.
Measured: 5 years
pregnancy outcome
The pregnancy outcomes in women who successfully conceived after undergoing fertility-sparing treatment. They can be categorized as: full-term delivery; premature delivery; miscarriage; stillbirth.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start21 Jun 2024
- Primary completionJul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, EndometrioidStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jianliu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468215
- Sponsor's protocol ID
- 2023G2ECFerSp
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06468215
- Acronym / sponsor ID
- 2023G2ECFerSp
- Conditions
- Carcinoma, Endometrioid, Fertility Preservation
- Keywords
- endometrial cancer, fertility-sparing treatment, grade 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 21 Jun 2024 (actual)
- 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.
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Fertility-sparing therapies (FST) are gaining popularity for early-stage, low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes. However, consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 (G2) endometrioid adenocarcinoma remains elusive. Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer, this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2.
Detailed description
This study aims to explore effective treatment options and pregnancy outcomes for G2 EC patients who wish to preserve their fertility. It compares the efficacy of monotherapy with progesterone versus combined therapy to determine the best treatment option.
This study is a multi-center, prospective, randomized controlled trial that collects hospital and outpatient records of uterine endometrioid adenocarcinoma patients who undergo fertility-sparing treatment at 10 units from October 2022. The basic items specified in the study are registered.
Selection criteria: Pathological diagnosis of endometrioid adenocarcinoma G2, MRI or ultrasound confirmed localization of the lesion within the endometrium, FIGO (FIGO, 2009) staging IA, age ≤ 45 years, and those who wish to preserve reproductive function, signed informed consent. Exclusion criteria: Tumor invasion of the muscle layer, FIGO (FIGO, 2009) staging IB or higher, tumor differentiation as G1, G3, or non-endometrioid adenocarcinoma, coexistence of malignant tumors in other sites, contraindications or drug prohibitions for conservative treatment, or judged by the investigator to be unsuitable for childbearing. Exclusion criteria: Violation of the treatment protocol; failure to take medication as prescribed, affecting the judgment of drug efficacy; incomplete data affecting the judgment of efficacy and safety. Withdrawal criteria: Intolerance of the used drugs or the appearance of serious complications, including venous or arterial thromboembolism, liver failure, renal failure, anaphylaxis, uterine perforation, etc.; no response to treatment or disease progression during drug therapy; when the patient requests termination of treatment.
Treatment Plan: The treatment plan was randomly divided into two groups. Group 1 was a single-drug treatment plan, with oral medroxyprogesterone acetate (MPA) 500mg/d or megestrol acetate (MA) 320mg/d; Group 2 was a combined treatment plan, with oral MPA 500mg/d/MA 320mg/d combined with the placement of levonorgestrel intrauterine system (LNG-IUS) in the uterus.
Since the treatment began, each 3-6 months is a course. At the end of each course, an endometrial biopsy is performed under hysteroscopy to conduct tissue pathological examination and evaluate the treatment effect. A vaginal color Doppler ultrasound is performed every month, and a pelvic MRI is re-evaluated as needed. Additionally, a side effect assessment is performed for each course, including weight, vaginal bleeding, breast discomfort, gastrointestinal symptoms, liver and kidney function, and thrombosis.
The efficacy assessment is divided into the following categories: (1) Complete Response (CR), (2) Partial Response (PR), (3) Disease Unresponsive or Stable Disease (NC/SD), (4) Disease Progression (PD), and (5) Relapse.
The main measurement indicator is the time required for the first complete remission. The secondary measurement indicators are the one-year complete remission rate, the two-year disease recurrence rate, the cumulative pregnancy rate, pregnancy duration, pregnancy outcomes, changes in serum indicators, and pathological markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients | Experimental | Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d. |
| The Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients | Experimental | Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD). |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Endometrioid adenocarcinoma G2, diagnosis by pathological.
- The lesion is limited to the endometrium.
- FIGO (2009) staging is IA.
- Age less than 45.
- Strongly request to preserve fertility.
Key exclusion criteria (6 listed)
- The tumor has invaded the muscle layer.
- FIGO (2009) stage IB or higher.
- Endometrioid adenocarcinoma G1, G3, or non-endometrioid cancer
- There are malignant tumors in other systems.
- Have contraindications for conservative treatment or drug use.
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 |
|---|---|---|
| Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.Also: Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD).Compare the efficacy of mono-therapy with progesterone versus combined therapy to determine the best treatment option. | Drug | Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients, The Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients |
Primary outcome
The Time Required for Complete Remission for the First Time
Time frame: 5 years
The time from the diagnosis of G2 endometrioid carcinoma to the first complete remission after fertility-preserving treatment.（year）
4 secondary outcomes
One-year complete remission rate
Time frame: 5 years
two-year disease recurrence rate
Time frame: 5 years
cumulative pregnancy rate
Time frame: 5 years
pregnancy outcome
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d. in people with Carcinoma, Endometrioid and Fertility Preservation, run by Peking University People's Hospital at 1 site in China.
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 6 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiqin Wang (008688324380, emily_wang92@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Time Required for Complete Remission for the First Time (time frame: 5 years). 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 21 Aug 2026.