Peking University People's Hosoital
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
NCT Number: NCT05945407
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Beijing, Beijing Municipality, 100044, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months after initial treatment
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
Time frame: 12 months after initial treatment
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
Time frame: 12 months after initial treatment
Time required to achieve complete remission.
Time frame: 1 year after complete remission
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
Time frame: 2 years after complete remission
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
Time frame: 2 years after complete remission
Time of recurrence after complete remission.
Time frame: 1 year after complete remission
A pregnancy test shows pregnancy after complete remission.
Time frame: 1 year after complete remission
Time of pregnancy.
Time frame: 1 year after pregnancy
The live birth rate is defined as the ratio of live births to pregnancies.
Time frame: every 3-6 months until 5 years after initial treatment
Used as a tumor marker for disease monitoring.
Time frame: every 3-6 months until 5 years after initial treatment
Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.
Time frame: every 3-6 months until 5 years after initial treatment
Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6).
Time frame: every 3-6 months until 5 years after initial treatment
Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.
Contact information is provided by the study sponsor or research team.
Peking University People's Hospital
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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