Fertility Sparing Therapy for Patients With Stage IA G2 Endometrial Cancer

NCT06468215 | Not Yet Recruiting

• 1 other identifier: 2023G2ECFerSp
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endometrial cancer (EC) is a prevalent gynecological cancer with an escalating global incidence and a decreasing age of onset. In the era of precision medicine, there is an increasing emphasis on tailoring treatments to different populations to optimize the positive impact of clinical interventions. Fertility-sparing therapies (FST) are gaining popularity for early-stage, low-grade endometrial cancer due to mounting evidence supporting favorable oncologic and pregnancy outcomes. However, consensus regarding the feasibility of fertility-sparing therapy for similar low-risk grade-2 (G2) endometrioid adenocarcinoma remains elusive. Given the uncertainties surrounding fertility-preserving therapy in patients with moderately differentiated endometrial cancer, this study aims to investigate the optimal regimen of fertility-preserving therapy for patients with IAG2.

Conditions

Carcinoma, Endometrioid; Fertility Preservation

Keywords

endometrial cancer; fertility-sparing treatment; grade 2

Outcome Measures

Primary Outcomes (1)

• The Time Required for Complete Remission for the First Time

  The time from the diagnosis of G2 endometrioid carcinoma to the first complete remission after fertility-preserving treatment.（year）

  5 years

Secondary Outcomes (4)

• One-year complete remission rate

  5 years

• two-year disease recurrence rate

  5 years

• cumulative pregnancy rate

  5 years

• pregnancy outcome

  5 years

Study Arms (2)

Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients

EXPERIMENTAL

Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.

Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.

The Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients

EXPERIMENTAL

Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD).

Drug: Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d.

Interventions

Treatment Option 1 is a single-drug regimen, with oral medroxyprogesterone acetate (MPA) 500mg/d or MA 320mg/d. DRUG

Compare the efficacy of mono-therapy with progesterone versus combined therapy to determine the best treatment option.

Also known as: Treatment Option 2 is a combination therapy, consisting of oral MPA 500mg/d/MA 320mg/d combined with the intrauterine insertion of the levonorgestrel intrauterine system (LNG-IUS, Mirena IUD).

Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients; The Study on Fertility Sparing Therapy in IA Stage G2 Endometrial Cancer Patients

Eligibility Criteria

• Age: Up to 45 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Endometrioid adenocarcinoma G2, diagnosis by pathological.
• The lesion is limited to the endometrium.
• FIGO (2009) staging is IA.
• Age less than 45.
• Strongly request to preserve fertility.
• Sign informed consent.

You may not qualify if:

• The tumor has invaded the muscle layer.
• FIGO (2009) stage IB or higher.
• Endometrioid adenocarcinoma G1, G3, or non-endometrioid cancer
• There are malignant tumors in other systems.
• Have contraindications for conservative treatment or drug use.
• Have been judged by the researcher to be unsuitable for childbearing.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Carcinoma, Endometrioid; Endometrial Neoplasms; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Uterine Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deaprtment of Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share