Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
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.
1 other identifier
interventional
57
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedJuly 14, 2023
July 1, 2023
7.4 years
March 26, 2023
July 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
9 months after initial treatment
Secondary Outcomes (13)
complete remission rate
6 months after initial treatment
complete remission rate
12 months after initial treatment
complete remission time
12 months after initial treatment
recurrence rate
1 year after complete remission
recurrence rate
2 years after complete remission
- +8 more secondary outcomes
Study Arms (2)
Myometrial invasion group
EXPERIMENTALPelvic 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
OTHERPelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium.
Interventions
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
You may qualify if:
- 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；
- years old ≤ Age ≤ 45 years old;
- With a strong desire for fertility preservation；
- Sign the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University People's Hospitallead
- Peking University Third Hospitalcollaborator
- Peking Union Medical College Hospitalcollaborator
- Third Military Medical Universitycollaborator
- Tianjin Medical University General Hospitalcollaborator
- Tongji Hospitalcollaborator
- Qilu Hospital of Shandong Universitycollaborator
- Shengjing Hospitalcollaborator
- Beijing Chao Yang Hospitalcollaborator
- Guang'anmen Hospital of China Academy of Chinese Medical Sciencescollaborator
Study Sites (1)
Peking University People's Hosoital
Beijing, Beijing Municipality, 100044, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jianliu Wang, Professor
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
March 26, 2023
First Posted
July 14, 2023
Study Start
August 1, 2016
Primary Completion
December 31, 2023
Study Completion (Estimated)
December 31, 2027
Last Updated
July 14, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share