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Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer

ConditionEndometrial Neoplasm Malignant Stage I
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFudan University

About this trial

To see if Gonadotropin-releasing hormone analogue (GnRHa) combined with aromatase inhibitors (AIs) will achieve better complete response rate than megestrol acetate or medroxyprogesterone acetate (MA/MPA) alone as fertility-sparing treatment for patients with early endometrial carcinoma.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Consent informed and signed

Primarily have a confirmed diagnosis of early-stage endometrial cancer (endometrioid, grade I, without myometrial inva- sion) ) based upon endometrial biopsy, diagnostic curettage or hysteroscopy

No signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS)

Have a strong desire for remaining reproductive function or uterus

Disqualifiers

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

Recurrent endometrial cancer

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

Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone- dependent tumors that cannot be used with progesterone

Trial design

Design model

Parallel

Treatments tested in this trial

  • Megestrol Acetate 160 MG Oral Tablet

    Drug

    At a dosage of 160 mg/day

  • Medroxyprogesterone Acetate 500 MG

    Drug

    At a dosage of 500 mg/day

  • Triprorelin Acetate

    Drug

    Intramuscular injection of 3.75mg was given 4 weeks apart and the maximum use are 6 courses

  • Letrozole 2.5mg

    Drug

    At a dosage of 2.5mg/day and no more than 24 weeks

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: GnRHa+letrozoleExperimental treatment 2 interventions
Group B: MA/MPAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Complete response rates within 16 weeks of treatment

The cumulative 16-week CR rates will be calculated in two groups

Time frame
From date of treatment initiation until the date of CR, assessed up to 16 weeks.

Secondary outcomes

1

Complete response rates within 28 weeks of treatment

The cumulative 28-week CR rates will be calculated in two groups

Time frame
From date of treatment initiation until the date of CR, 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 treatment initiation until the date of CR or date of hysterectomy,From date of randomization until the date of CR, assessed up to 2 years
3

Adverse events

Adverse events related with Medroxyprogesterone Acetate, Megestrol Acetate, Triprorelin Acetate and Letrozole. 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 treatment initiation until the date of CR, assessed up to 2 years
4

Quality of life during the treatment accessed by WHOQOL-BREF

Quality of life will be assessed at baseline, 4 weeks and every 12-16 weeks of treatment, using WHOQOL-BREF scale including assessment on pain, energy,sleep,mobil,activity,medication,work,positive feeling,think,esteem,body,negtivity,spirit,relationship,support,sex,safety,home,finance,service,information, environment,leisure,transport

Time frame
From date of randomization until 12 weeks after treatment is over.

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Peking Union Medical College Hospital

Collaborator

Source ClinicalTrials.gov
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