Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeUp to 45
SponsorPeking University People's Hospital
About this trial
Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Fertility-sparing therapies (FST) are gaining popularity for early-stage, low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes. However, consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 (G2) endometrioid adenocarcinoma remains elusive. Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer, this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Endometrioid adenocarcinoma G2, diagnosis by pathological.
The lesion is limited to the endometrium.
FIGO (2009) staging is IA.
Age less than 45.
Disqualifiers
The tumor has invaded the muscle layer.
FIGO (2009) stage IB or higher.
Endometrioid adenocarcinoma G1, G3, or non-endometrioid cancer
There are malignant tumors in other systems.
Trial design
Design model
Parallel
Treatments tested in this trial
Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.
DrugCompare the efficacy of mono-therapy with progesterone versus combined therapy to determine the best treatment option.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer PatientsExperimental treatment 1 intervention
Group B: The Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Time Required for Complete Remission for the First Time
The time from the diagnosis of G2 endometrioid carcinoma to the first complete remission after fertility-preserving treatment.（year）
Time frame
5 yearsSecondary outcomes
1
One-year complete remission rate
The percentage of patients who achieved complete remission after one year of fertility preservation treatment.
Time frame
5 years2
two-year disease recurrence rate
The probability of recurrence within 2 years for patients who underwent treatment for preserving fertility and achieved complete remission.
Time frame
5 years3
cumulative pregnancy rate
The percentage of pregnancies that occurred during the observation period.
Time frame
5 years4
pregnancy outcome
The pregnancy outcomes in women who successfully conceived after undergoing fertility-sparing treatment. They can be categorized as: full-term delivery; premature delivery; miscarriage; stillbirth.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov