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Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium

ConditionsEndometrial CancerAtypical HyperplasiaFertility Perservation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-41
SponsorGynOncTrials

About this trial

The incidence of endometrial cancer is increasing at an alarming rate. This trend parallels the rising rate of obesity, the most significant risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility are treated with progestin therapy, such as progestin intra-uterine device (pIUD), which is associated with a mediocre response rate and high recurrence rate, and does not address the underlying cause, obesity. Therefore, the investigators want to assess whether the addition of a weight-loss drug to pIUD will improve their oncologic, reproductive and metabolic outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≥ 27

Diagnosis of grade 1 endometrioid endometrial cancer or atypical hyperplasia made by either endometrial biopsy or dilation and curettage

For those with endometrial cancer, clinical FIGO 2009 stage 1A disease without evidence of metastatic disease beyond the uterus and no myometrial invasion by MRI or CT

ECOG status <2

Disqualifiers

Evidence of myometrial invasion or extra-uterine disease on imaging

High grade or p53 mutated (p53mut) endometrial cancer

Estrogen receptor negative endometrial cancer (positivity defined as moderate/strong staining>10%)

Mismatch repair deficient (MMRd) endometrial cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Wegovy

    Drug

    Weekly subcutaneous injection of 0.25 mg semaglutide at baseline with dose escalation every 4 weeks to reach 2.4 mg or the maximum tolerated dose, by Week 16

  • Mirena

    Drug

    Levonorgestrel-releasing Intrauterine System (52mg) to deliver up to 20 mcg levonorgestrel per day

Treatment groups

71 Participants
are divided into 1 treatment group
Group A: Semaglutide and Progestin Intrauterine DeviceExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Assessment of Complete Pathologic Response

Proportion of patients (%) who achieve pathological complete response at 48 weeks after initiation of pIUD and semaglutide.

Time frame
48 weeks

Secondary outcomes

1

Assessment of Safety and Tolerability

Adverse events during treatment period

Time frame
48 weeks
2

Assessment of Feasibility

Rate of accrual; patient compliance; retention

Time frame
1.5 years
3

Assessment of Secondary Oncologic Outcomes

Time to achieve complete response; duration of response; recurrence rate; time to recurrence; progression/persistence rate

Time frame
6 years
4

Assessment of Reproductive Outcomes

Rate of pregnancy; live birth; miscarriage; pregnancy complications

Time frame
6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GynOncTrials

Lead sponsor

University Health Network, Toronto

Sponsor institution

Source ClinicalTrials.gov
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