Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

NARecruitingINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

August 1, 2016

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2027

Conditions
Endometrial NeoplasmsEndometrial Neoplasm MalignantEndometrial Neoplasm Malignant Stage ICarcinoma, EndometrioidFertility Preservation
Interventions
COMBINATION_PRODUCT

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."

Trial Locations (1)

100044

RECRUITING

Peking University People's Hosoital, Beijing

All Listed Sponsors
collaborator

Peking University Third Hospital

OTHER

collaborator

Peking Union Medical College Hospital

OTHER

collaborator

Third Military Medical University

OTHER

collaborator

Tianjin Medical University General Hospital

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Shengjing Hospital

OTHER

collaborator

Beijing Chao Yang Hospital

OTHER

collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

lead

Peking University People's Hospital

OTHER