GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients

NCT06379113RecruitingPHASE2, PHASE3INTERVENTIONAL

Summary

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

Key Facts

Lead Sponsor

Xiaojun Chen

Enrollment

29

Start Date

2022-07-13

Completion Date

2026-03-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

GnRH antagonistLetrozole 2.5mg

Conditions

Endometrial NeoplasmsAtypical Endometrial HyperplasiaProgesterone ResistanceObesity

Eligibility

Age Range

18 Years – 45 Years

Sex

FEMALE

Inclusion Criteria:

* 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:

  1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
  2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
  3. LNG-IUS inserted
* Progestin-insensitive:

  1. remained with stable disease after 7 months of progestin use
  2. 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

Exclusion Criteria:

* 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
* Strong request for uterine removal or other conservative treatment
* Known or suspected pregnancy
* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
* Smoker(\>15 cigarettes a day)

Outcome Measures

Primary Outcomes

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 weeks

Secondary Outcomes

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 weeks

Time to achieve complete response

The median CR time will be calculated.

Time frame: Up to 28 weeks

Relapse rates

Time frame: Through study completion, an average of 2 years

Rates of fertility outcomes

Time frame: Through study completion, an average of 2 years

Compliance

Data on treatment and hysteroscopy management will be collected, and deviations from study protocol will be recorded in writing. For example, the time of drug interruptions due to related toxicities or AEs, and delay of hysteroscopy for personal reasons.

Time frame: Through study completion, an average of 28 weeks

Locations

Tenth People's Hospital of Tongji University, Shanghai, China

Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China

GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients