Endometrial NeoplasmsNCT05945407
Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
A study testing Indication-extended Fertility-sparing Therapy in people with Endometrial Neoplasms and Endometrial Neoplasm Malignant, run by Peking University People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Neoplasms, Endometrial Neoplasm Malignant, Endometrial Neoplasm Malignant Stage I
- What is being tested?
- Indication-extended Fertility-sparing Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 31 Dec 2027
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Stage IA (FIGO 2009) ;
- Pathological diagnosis: endometrial adenocarcinoma G1-G2;
- MRI or ultrasound: tumor limited to endometrium or invading less than 1/2 of myometrium；
- 18 years old ≤ Age ≤ 45 years old;
- With a strong desire for fertility preservation；
- Sign the informed consent.
Who cannot join
- Complicated with any other malignancy；
- Contraindications to conservative treatment；
- Contraindications to progestin use;
- Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.
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 Hosoital
Beijing, Beijing Municipality, 100044
Jianliu Wang, Professor, 0086-010-88324381, wangjianliu@pku.edu.cn
About this study
Official title: Establishment of a Network Platform for Fertility-sparing in Patients With Endometrial Cancer and Study on Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer.
The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.
Read the detailed description
The study population is patients with Stage IA endometrial adenocarcinoma with no myometrial invasion or less than 1/2 myometrial invasion. The sample size is 57 cases (Myometrial invasion group : No myometrial invasion group = 1 : 2). Follow up every 3-6 months until the end of the fifth year of treatment. The primary outcome measure is the complete remission rate after 9 months of treatment. Secondary outcome measures include complete remission rate (6 months/12 months after initial treatment), complete remission time, recurrence rate (1 year/2 years after complete remission), recurrence time, pregnancy rate (1 year after complete remission), pregnancy outcome, blood molecular biomarkers, pathological markers, adverse reactions, etc.
- Conditions
- Endometrial Neoplasms, Endometrial Neoplasm Malignant, Endometrial Neoplasm Malignant Stage I, Carcinoma, Endometrioid, Fertility Preservation
- Being tested
- Indication-extended Fertility-sparing Therapy
- Keywords
- Fertility-sparing, Fertility-preserving, Endometrial Carcinoma, Endometrial Cancer, Indication Extension
- Medical subject headings
- Endometrial Neoplasms, Carcinoma, Endometrioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indication-extended Fertility-sparing TherapyCombination product
Patients will receive medroxyprogesterone acetate ("FARLUTAL") 250-500mg/d or megestrol acetate ("YiLiZhi") 160-320mg/d orally. If there is no response after 6 months of treatment, change the regimen to levonorgestrel intrauterine system ("Mirena") and gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin") 3.75mg/28d injection subcutaneously. After complete remission, the same regimen will be used for consolidation treatment for another 1-3 months. Subsequently, if the patient has no intention of pregnancy, render maintenance treatment ("Mirena", "Progesterone", "Dydrogesterone", or combined oral contraceptive). Otherwise, the patient will be encouraged to conceive either by an expectation for 3-6 months, or by assisted reproductive technology. Indications for stopping fertility-sparing therapy: 1) disease progression; 2) no response after 9 months of treatment; 3) repeated recurrence; 4) no longer require sparing fertility; 5) serious adverse reactions.
| Study group | Role | What they receive |
|---|---|---|
| Myometrial invasion group | Experimental | Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium. Receives: Combination Product: Indication-extended Fertility-sparing Therapy |
| No myometrial invasion group | Other | Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium. Receives: Combination Product: Indication-extended Fertility-sparing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
Measured: 9 months after initial treatment
Secondary outcomes (13)
complete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
Measured: 6 months after initial treatment
complete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
Measured: 12 months after initial treatment
complete remission time
Time required to achieve complete remission.
Measured: 12 months after initial treatment
recurrence rate
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
Measured: 1 year after complete remission
recurrence rate
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
Measured: 2 years after complete remission
recurrence time
Time of recurrence after complete remission.
Measured: 2 years after complete remission
pregnancy rate
A pregnancy test shows pregnancy after complete remission.
Measured: 1 year after complete remission
pregnancy time
Time of pregnancy.
Measured: 1 year after complete remission
live birth rate
The live birth rate is defined as the ratio of live births to pregnancies.
Measured: 1 year after pregnancy
CA125
Used as a tumor marker for disease monitoring.
Measured: every 3-6 months until 5 years after initial treatment
HOMA-IR
Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.
Measured: every 3-6 months until 5 years after initial treatment
pathological markers
Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6).
Measured: every 3-6 months until 5 years after initial treatment
adverse reactions
Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.
Measured: every 3-6 months until 5 years after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Aug 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University People's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Peking Union Medical College Hospital, Third Military Medical University, Tianjin Medical University General Hospital, Tongji Hospital, Qilu Hospital of Shandong University, Shengjing Hospital, Beijing Chao Yang Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Wang Jianliu, Peking University People's Hospital
- Investigators
- Jianliu Wang, Professor, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945407
- Sponsor's protocol ID
- 2017ECFerSp
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2023
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Network Platform for Fertility-sparing in Patients With Endometrial Cancer and Study on Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer.
- ClinicalTrials.gov ID
- NCT05945407
- Acronym / sponsor ID
- 2017ECFerSp
- Conditions
- Endometrial Neoplasms, Endometrial Neoplasm Malignant, Endometrial Neoplasm Malignant Stage I, Carcinoma, Endometrioid, Fertility Preservation
- Keywords
- Fertility-sparing, Fertility-preserving, Endometrial Carcinoma, Endometrial Cancer, Indication Extension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Peking Union Medical College Hospital, Third Military Medical University, Tianjin Medical University General Hospital, Tongji Hospital, Qilu Hospital of Shandong University, Shengjing Hospital, Beijing Chao Yang Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jul 2023 (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.
The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.
Detailed description
The study population is patients with Stage IA endometrial adenocarcinoma with no myometrial invasion or less than 1/2 myometrial invasion. The sample size is 57 cases (Myometrial invasion group : No myometrial invasion group = 1 : 2). Follow up every 3-6 months until the end of the fifth year of treatment. The primary outcome measure is the complete remission rate after 9 months of treatment. Secondary outcome measures include complete remission rate (6 months/12 months after initial treatment), complete remission time, recurrence rate (1 year/2 years after complete remission), recurrence time, pregnancy rate (1 year after complete remission), pregnancy outcome, blood molecular biomarkers, pathological markers, adverse reactions, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myometrial invasion group | Experimental | Combination Product: Indication-extended Fertility-sparing TherapyPelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium. |
| No myometrial invasion group | Other | Combination Product: Indication-extended Fertility-sparing TherapyPelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Stage IA (FIGO 2009) ;
- Pathological diagnosis: endometrial adenocarcinoma G1-G2;
- MRI or ultrasound: tumor limited to endometrium or invading less than 1/2 of myometrium；
- 18 years old ≤ Age ≤ 45 years old;
- With a strong desire for fertility preservation；
Key exclusion criteria (4 listed)
- Complicated with any other malignancy；
- Contraindications to conservative treatment；
- Contraindications to progestin use;
- Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.
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 |
|---|---|---|
| Indication-extended Fertility-sparing TherapyPatients will receive medroxyprogesterone acetate ("FARLUTAL") 250-500mg/d or megestrol acetate ("YiLiZhi") 160-320mg/d orally. If there is no response after 6 months of treatment, change the regimen to levonorgestrel intrauterine system ("Mirena") and gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin") 3.75mg/28d injection subcutaneously. After complete remission, the same regimen will be used for consolidation treatment for another 1-3 months. Subsequently, if the patient has no intention of pregnancy, render maintenance treatment ("Mirena", "Progesterone", "Dydrogesterone", or combined oral contraceptive). Otherwise, the patient will be encouraged to conceive either by an expectation for 3-6 months, or by assisted reproductive technology. Indications for stopping fertility-sparing therapy: 1) disease progression; 2) no response after 9 months of treatment; 3) repeated recurrence; 4) no longer require sparing fertility; 5) serious adverse reactions. | Combination product | Myometrial invasion group, No myometrial invasion group |
Primary outcome
complete remission rate
Time frame: 9 months after initial treatment
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
13 secondary outcomes
complete remission rate
Time frame: 6 months after initial treatment
complete remission rate
Time frame: 12 months after initial treatment
complete remission time
Time frame: 12 months after initial treatment
recurrence rate
Time frame: 1 year after complete remission
recurrence rate
Time frame: 2 years after complete remission
recurrence time
Time frame: 2 years after complete remission
pregnancy rate
Time frame: 1 year after complete remission
pregnancy time
Time frame: 1 year after complete remission
live birth rate
Time frame: 1 year after pregnancy
CA125
Time frame: every 3-6 months until 5 years after initial treatment
HOMA-IR
Time frame: every 3-6 months until 5 years after initial treatment
pathological markers
Time frame: every 3-6 months until 5 years after initial treatment
adverse reactions
Time frame: every 3-6 months until 5 years after initial treatment
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 14 Jul 2023.
- 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.
Jianliu Wang, Professor study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indication-extended Fertility-sparing Therapy in people with Endometrial Neoplasms and Endometrial Neoplasm Malignant, 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 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: looking for participants now, as of the sponsor's last update on 14 Jul 2023. 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 Jianliu Wang, Professor (0086-010-88324381, wangjianliu1203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: 9 months after initial treatment). 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 14 Jul 2023.