Actively Recruiting
Establishment of a Network Platform for Fertility-sparing Therapy in Patients With Stage IA Endometrial Cancer
Led by Peking University People's Hospital · Updated on 2023-07-14
57
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
P
Peking University Third Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on patients with Stage IA endometrial adenocarcinoma who have either no myometrial invasion or less than half myometrial invasion. The goal is to explore the feasibility and outcomes of fertility-sparing therapy in these patients, comparing those with myometrial invasion to those without. The study aims to see if fertility-sparing treatment can be safely extended to patients with limited myometrial invasion. Participants will receive an indication-extended fertility-sparing therapy that begins with oral medroxyprogesterone acetate or megestrol acetate. If there is no response after 6 months, treatment can be changed to a levonorgestrel intrauterine system combined with monthly injections of gonadotropin-releasing hormone agonists. After complete remission, consolidation treatment continues for 1 to 3 months. Depending on pregnancy intentions, patients may receive maintenance treatment or be encouraged to conceive naturally or with assisted reproductive technology. The study groups include those with less than half myometrial invasion and those with no invasion. Participants will be followed every 3 to 6 months for up to five years. Researchers will monitor remission rates at various time points, recurrence rates, pregnancy rates, and pregnancy outcomes. Blood tests and pathological markers will be assessed regularly alongside monitoring for any adverse reactions. The primary outcome is the complete remission rate after 9 months of treatment. This long-term follow-up will help evaluate safety and effectiveness of fertility-sparing treatment in this patient group.
CONDITIONS
Brief Title
Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage IA (FIGO 2009)
- Pathological diagnosis of endometrial adenocarcinoma grade 1 or 2
- Tumor limited to the endometrium or invading less than half of the myometrium as shown by MRI or ultrasound
- Female aged between 18 and 45 years
- Strong desire to preserve fertility
- Signed informed consent
You will not qualify if you...
- Having any other malignancy
- Contraindications to conservative treatment
- Contraindications to progestin use
- Contraindications to pregnancy or judged unfit for pregnancy or delivery by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months or until disease progression or treatment discontinuation
Participants receive fertility-sparing therapy with oral medroxyprogesterone acetate or megestrol acetate. If no response after 6 months, treatment changes to levonorgestrel intrauterine system and gonadotropin-releasing hormone agonist injections. After complete remission, consolidation treatment continues for 1 to 3 months. Maintenance treatment or attempts to conceive follow based on participant's pregnancy intentions.
Visits every 3 to 6 months during treatment
Duration - Up to 5 years after initial treatment
Participants are monitored every 3 to 6 months for up to 5 years after initial treatment to assess remission status, recurrence, pregnancy outcomes, blood molecular biomarkers, pathological markers, and adverse reactions.
Visits every 3 to 6 months for follow-up assessments
Trial Site Locations
Total: 1 location
1
Peking University People's Hosoital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
J
Jianliu Wang, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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