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GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients

ConditionsEndometrial NeoplasmsAtypical Endometrial HyperplasiaProgesterone Resistance
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorXiaojun Chen

About this trial

To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or well-differentiated EEC G1 without myometrial invasion

BMI<30kg/m2

No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound

Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not

Disqualifiers

Combined with severe medical disease or severely impaired liver and kidney function

Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis

Patients with other types of endometrial cancer or other malignant tumors of the reproductive system

Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with Diane-35, GnRHa, Letrozole or MET

Trial design

Design model

Parallel

Treatments tested in this trial

  • GnRHa

    Drug

    Gonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks , and the maximum using courses will be 6.

  • Letrozole 2.5mg

    Drug

    2.5mg po qd and no more than 24 weeks

  • Diane-35

    Drug

    Periodic use. Patients will receive one pill po qd for 21 days, and next period should be started after 7 days.

  • MET

    Drug

    500mg po tid

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Non-obese EEC group (G)Experimental treatment 2 interventions
Group B: Non-obese EEC group (D)Experimental treatment 2 interventions
Group C: Non-obese EAH group (G)Experimental treatment 2 interventions
Group D: Non-obese EAH group (D)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete response rates within 28 weeks of treatment

The cumulative 28-week CR rates will be calculated in two groups. Patients will be evaluated with an hysteroscopy every 12 weeks. For some may delay the evaluation as personal reasons, we define the primary outcome measure as complete response rates within 28 weeks of treatment.

Time frame
From date of randomization until the date of CR, assessed up to 28 weeks

Secondary outcomes

1

Adverse events

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be recorded, as well as incidence of adverse events.

Time frame
From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks
2

Time to achieve complete response

The median CR time will be calculated in two groups

Time frame
From date of randomization until the date of CR or date of hysterectomy, assessed up to 28 weeks.
3

Relapse rates

Time frame
Up to 2 years after the treatment
4

Rates of fertility outcomes

Including pregnancy and live-birth rates

Time frame
Up to 2 years after the treatment

Other outcomes

Sponsors and contacts

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

Xiaojun Chen

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov
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