Fertility-sparing therapy for early-stage endometrial cancer
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.
This study is testing a new treatment approach for women with early-stage endometrial cancer to see if it can help them keep their ability to have children while also checking how well it works over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05945407 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and outcomes of fertility-sparing therapy in patients with Stage IA endometrial adenocarcinoma, specifically those with less than 1/2 myometrial invasion. The study will involve 57 participants, comparing those with myometrial invasion to those without, to assess the potential for extending fertility-sparing treatment indications. Follow-up assessments will occur every 3-6 months for up to five years, focusing on complete remission rates, recurrence rates, and pregnancy outcomes. The primary goal is to determine the complete remission rate after 9 months of treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 with Stage IA endometrial adenocarcinoma and a strong desire for fertility preservation.
Not a fit: Patients with other malignancies, contraindications to conservative treatment, or those deemed unfit for pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could allow women with early-stage endometrial cancer to preserve their fertility while effectively treating their cancer.
How similar studies have performed: Other studies have shown promising results with fertility-sparing approaches in endometrial cancer, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hosoital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jianliu Wang, Professor
- Email: wangjianliu1203@163.com
- Phone: 0086-010-88324381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.