Menu
Recruiting NCT05945407

Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

No phase Interventional Endometrial Neoplasms Endometrial Neoplasm Malignant Endometrial Neoplasm Malignant Stage I Carcinoma, Endometrioid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indication-extended Fertility-sparing Therapy.
Who it may be relevant to
Registry conditions: Endometrial Neoplasms, Endometrial Neoplasm Malignant, Endometrial Neoplasm Malignant Stage I, Carcinoma, Endometrioid. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Detailed description

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.

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

Primary outcome measures

  • complete remission rate [Time frame: 9 months after initial treatment]
Secondary outcome measures (12)
  • complete remission rate [Time frame: 6 months after initial treatment]
  • complete remission rate [Time frame: 12 months after initial treatment]
  • complete remission time [Time frame: 12 months after initial treatment]
  • recurrence rate [Time frame: 1 year after complete remission]
  • recurrence rate [Time frame: 2 years after complete remission]
  • recurrence time [Time frame: 2 years after complete remission]
  • pregnancy rate [Time frame: 1 year after complete remission]
  • pregnancy time [Time frame: 1 year after complete remission]
  • live birth rate [Time frame: 1 year after pregnancy]
  • CA125 [Time frame: every 3-6 months until 5 years after initial treatment]
  • HOMA-IR [Time frame: every 3-6 months until 5 years after initial treatment]
  • pathological markers [Time frame: every 3-6 months until 5 years after initial treatment]

Eligibility criteria

Inclusion criteria

  • 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;
  • With a strong desire for fertility preservation；
  • Sign the informed consent.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hosoital — Beijing

Identifiers

NCT: NCT05945407 · 2017ECFerSp

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗