GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients
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 in obese progestin-insensitive EEC patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove 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 GnRHa or Letrozole
Trial design
Design model
Single group
Treatments tested in this trial
GnRH antagonist
DrugGonadotropin-releasing hormone analogue, intramuscular injection of 3.75mg will be given every 4 weeks, and the maximum treatment courses will be 6. If the patient get CR within 6 courses, another 2 courses will be used as consolidation therapy.
Letrozole 2.5mg
Drug2.5mg po qd.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Obese EEC groupExperimental 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 to 16 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
Up to 28 weeksSecondary 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
Through study completion, an average of 28 weeks2
Time to achieve complete response
The median CR time will be calculated.
Time frame
Up to 28 weeks3
Relapse rates
Time frame
Through study completion, an average of 2 years4
Rates of fertility outcomes
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaojun Chen
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov