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.
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;
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.
Parallel
Indication-extended Fertility-sparing Therapy
Combination productPatients 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.
complete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
complete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
complete remission rate
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
complete remission time
Time required to achieve complete remission.
recurrence rate
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
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Peking University People's Hospital
Lead sponsor
Peking University Third Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
Third Military Medical University
Collaborator
Tianjin Medical University General Hospital
Collaborator
Tongji Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Shengjing Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator
