Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
NCT ID: NCT05945407
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
57 participants
INTERVENTIONAL
2016-08-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Myometrial invasion group
Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium.
Indication-extended Fertility-sparing Therapy
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.
No myometrial invasion group
Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium.
Indication-extended Fertility-sparing Therapy
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.
Interventions
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Indication-extended Fertility-sparing Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Contraindications to conservative treatment；
* Contraindications to progestin use;
* Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.
18 Years
45 Years
FEMALE
No
Sponsors
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Peking University Third Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Third Military Medical University
OTHER
Tianjin Medical University General Hospital
OTHER
Tongji Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Shengjing Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Wang Jianliu
Chief physician
Principal Investigators
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Jianliu Wang, Professor
Role: STUDY_DIRECTOR
Peking University People's Hospital
Locations
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Peking University People's Hosoital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017ECFerSp
Identifier Type: -
Identifier Source: org_study_id
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