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Trial Title:
Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
NCT ID:
NCT05945407
Condition:
Endometrial Neoplasms
Endometrial Neoplasm Malignant
Endometrial Neoplasm Malignant Stage I
Carcinoma, Endometrioid
Fertility Preservation
Conditions: Official terms:
Neoplasms
Endometrial Neoplasms
Carcinoma, Endometrioid
Conditions: Keywords:
Fertility-sparing
Fertility-preserving
Endometrial Carcinoma
Endometrial Cancer
Indication Extension
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Indication-extended Fertility-sparing Therapy
Description:
Patients will receive medroxyprogesterone acetate ("FARLUTAL") 250-500mg/d or megestrol
acetate ("YiLiZhi") 160-320mg/d orally. If there is no response after 6 months of
treatment, change the regimen to levonorgestrel intrauterine system ("Mirena") and
gonadotropin-releasing hormone agonist ("Leuprorelin", "Goserelin" or "Triptorelin")
3.75mg/28d injection subcutaneously. After complete remission, the same regimen will be
used for consolidation treatment for another 1-3 months. Subsequently, if the patient has
no intention of pregnancy, render maintenance treatment ("Mirena", "Progesterone",
"Dydrogesterone", or combined oral contraceptive). Otherwise, the patient will be
encouraged to conceive either by an expectation for 3-6 months, or by assisted
reproductive technology. Indications for stopping fertility-sparing therapy: 1) disease
progression; 2) no response after 9 months of treatment; 3) repeated recurrence; 4) no
longer require sparing fertility; 5) serious adverse reactions.
Arm group label:
Myometrial invasion group
Arm group label:
No myometrial invasion group
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
Based on biological sex.
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hosoital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianliu Wang, Professor
Phone:
0086-010-88324381
Email:
wangjianliu@pku.edu.cn
Start date:
August 1, 2016
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Third Military Medical University
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University General Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
Shengjing Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Chao Yang Hospital
Agency class:
Other
Collaborator:
Agency:
Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05945407
