Clinical trial NCT05945407: Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
Official title: Establishment of a Network Platform for Fertility-sparing in Patients With Endometrial Cancer and Study on Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Neoplasms
Endometrial Neoplasm Malignant
Endometrial Neoplasm Malignant Stage I
Carcinoma, Endometrioid
Fertility Preservation
Keywords: Fertility-sparing
Fertility-preserving
Endometrial Carcinoma
Endometrial Cancer
Indication Extension
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking Union Medical College Hospital
name: Third Military Medical University
name: Tianjin Medical University General Hospital
name: Tongji Hospital
name: Qilu Hospital of Shandong University
name: Shengjing Hospital
name: Beijing Chao Yang Hospital
name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First posted: 2023-07-14
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.

Detailed description: The study population is patients with Stage IA endometrial adenocarcinoma with no myometrial invasion or less than 1/2 myometrial invasion. The sample size is 57 cases (Myometrial invasion group : No myometrial invasion group = 1 : 2). Follow up every 3-6 months until the end of the fifth year of treatment. The primary outcome measure is the complete remission rate after 9 months of treatment. Secondary outcome measures include complete remission rate (6 months/12 months after initial treatment), complete remission time, recurrence rate (1 year/2 years after complete remission), recurrence time, pregnancy rate (1 year after complete remission), pregnancy outcome, blood molecular biomarkers, pathological markers, adverse reactions, etc.

Eligibility criteria: Inclusion Criteria:

* Stage IA (FIGO 2009) ;
* Pathological diagnosis: endometrial adenocarcinoma G1-G2;
* MRI or ultrasound: tumor limited to endometrium or invading less than 1/2 of myometrium；
* 18 years old ≤ Age ≤ 45 years old;
* With a strong desire for fertility preservation；
* Sign the informed consent.

Exclusion Criteria:

* Complicated with any other malignancy；
* Contraindications to conservative treatment；
* Contraindications to progestin use;
* Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.

Primary outcomes:
measure: complete remission rate
timeFrame: 9 months after initial treatment
Secondary outcomes:
measure: complete remission rate
timeFrame: 6 months after initial treatment
measure: complete remission rate
timeFrame: 12 months after initial treatment
measure: complete remission time
timeFrame: 12 months after initial treatment
measure: recurrence rate
timeFrame: 1 year after complete remission
measure: recurrence rate
timeFrame: 2 years after complete remission
measure: recurrence time
timeFrame: 2 years after complete remission
measure: pregnancy rate
timeFrame: 1 year after complete remission
measure: pregnancy time
timeFrame: 1 year after complete remission
measure: live birth rate
timeFrame: 1 year after pregnancy
measure: CA125
timeFrame: every 3-6 months until 5 years after initial treatment
measure: HOMA-IR
timeFrame: every 3-6 months until 5 years after initial treatment
measure: pathological markers
timeFrame: every 3-6 months until 5 years after initial treatment
measure: adverse reactions
timeFrame: every 3-6 months until 5 years after initial treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hosoital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jianliu Wang, Professor
role: STUDY_DIRECTOR
References: