GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia 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 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
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
Treatments tested in this trial
- GnRHa
- Letrozole 2.5mg
- Diane-35
- MET
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Xiaojun Chen
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov