Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Early-stage Endometrial Cancer Patients With Conservative Treatment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

• Using progestin, any of the following therapy, as first-line treatment:

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

⁃ Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not

⁃ LNG-IUS inserted

• Progestin-insensitive:

‣ remained with stable disease after 7 months of progestin use

⁃ did not achieve CR after 10 months of progestin use

• Have a desire for remaining reproductive function or uterus

• Good compliance with adjunctive treatment and follow-up

Locations
Other Locations
China
Obstetrics and Gynecology Hospital, Fudan University
RECRUITING
Shanghai
Tenth People's Hospital of Tongji University
RECRUITING
Shanghai
Contact Information
Primary
Xiaojun Chen, PhD
cxjlhjj@163.com
8602133189900
Backup
Pengfei Wu
leofinger@163.com
8602133189900
Time Frame
Start Date: 2022-07-13
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 29
Treatments
Experimental: Obese EEC group
This group including 29 EEC cases. Interventional Study Model was Simon two-stage optimal design. Eleven patients were needed for the first stage, and if eight or more patients achieved CR at 28 weeks, the trial can enter into the second stage.~Then every 12 to 16 weeks, an hysteroscope will be used to evaluate the endometrial condition, and the pathological findings will be recorded.
Related Therapeutic Areas
Sponsors
Leads: Xiaojun Chen

This content was sourced from clinicaltrials.gov

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