Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06468215 |
| Other study ID # |
2023G2ECFerSp |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2024 |
| Est. completion date |
October 2028 |
Study information
| Verified date |
June 2024 |
| Source |
Peking University People's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
Description:
This study aims to explore effective treatment options and pregnancy outcomes for G2 EC
patients who wish to preserve their fertility. It compares the efficacy of monotherapy with
progesterone versus combined therapy to determine the best treatment option.
This study is a multi-center, prospective, randomized controlled trial that collects hospital
and outpatient records of uterine endometrioid adenocarcinoma patients who undergo
fertility-sparing treatment at 10 units from October 2022. The basic items specified in the
study are registered.
Selection criteria: Pathological diagnosis of endometrioid adenocarcinoma G2, MRI or
ultrasound confirmed localization of the lesion within the endometrium, FIGO (FIGO, 2009)
staging IA, age ≤ 45 years, and those who wish to preserve reproductive function, signed
informed consent. Exclusion criteria: Tumor invasion of the muscle layer, FIGO (FIGO, 2009)
staging IB or higher, tumor differentiation as G1, G3, or non-endometrioid adenocarcinoma,
coexistence of malignant tumors in other sites, contraindications or drug prohibitions for
conservative treatment, or judged by the investigator to be unsuitable for childbearing.
Exclusion criteria: Violation of the treatment protocol; failure to take medication as
prescribed, affecting the judgment of drug efficacy; incomplete data affecting the judgment
of efficacy and safety. Withdrawal criteria: Intolerance of the used drugs or the appearance
of serious complications, including venous or arterial thromboembolism, liver failure, renal
failure, anaphylaxis, uterine perforation, etc.; no response to treatment or disease
progression during drug therapy; when the patient requests termination of treatment.
Treatment Plan: The treatment plan was randomly divided into two groups. Group 1 was a
single-drug treatment plan, with oral MPA 500mg/d or MA 320mg/d; Group 2 was a combined
treatment plan, with oral MPA 500mg/d/MA 320mg/d combined with the placement of
levonorgestrel intrauterine system (LNG-IUS) in the uterus.
Since the treatment began, each 3-6 months is a course. At the end of each course, an
endometrial biopsy is performed under hysteroscopy to conduct tissue pathological examination
and evaluate the treatment effect. A vaginal color Doppler ultrasound is performed every
month, and a pelvic MRI is re-evaluated as needed. Additionally, a side effect assessment is
performed for each course, including weight, vaginal bleeding, breast discomfort,
gastrointestinal symptoms, liver and kidney function, and thrombosis.
The efficacy assessment is divided into the following categories: (1) Complete Response (CR),
(2) Partial Response (PR), (3) Disease Unresponsive or Stable Disease (NC/SD), (4) Disease
Progression (PD), and (5) Relapse.
The main measurement indicator is the time required for the first complete remission. The
secondary measurement indicators are the one-year complete remission rate, the two-year
disease recurrence rate, the cumulative pregnancy rate, pregnancy duration, pregnancy
outcomes, changes in serum indicators, and pathological markers.
