Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

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.

Conditions

• Endometrial Neoplasms
• Endometrial Neoplasm Malignant
• Endometrial Neoplasm Malignant Stage I
• Carcinoma, Endometrioid
• Fertility 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.

Sponsors & Collaborators

• Peking University Third Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Third Military Medical University

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Peking University People's Hospital

  lead OTHER

Principal Investigators

• Jianliu Wang, Professor · Peking University People's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-01

Primary Completion

2023-12-31

Completion

2027-12-31

Countries

• China

Study Locations