Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Myometrial invasion group Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor invades less than one half of the myometrium. |
Combination Product: Indication-extended Fertility-sparing Therapy
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.
|
| Other: No myometrial invasion group Pelvic enhanced magnetic resonance imaging or transvaginal color Doppler ultrasound suggests that the tumor is limited to the endometrium. |
Combination Product: Indication-extended Fertility-sparing Therapy
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.
|
Outcome Measures
Primary Outcome Measures
- complete remission rate [9 months after initial treatment]
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
Secondary Outcome Measures
- complete remission rate [6 months after initial treatment]
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
- complete remission rate [12 months after initial treatment]
No endometrioid carcinoma or any proliferative lesion is found by pathology; imaging examination shows no evidence of a tumor.
- complete remission time [12 months after initial treatment]
Time required to achieve complete remission.
- recurrence rate [1 year after complete remission]
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
- recurrence rate [2 years after complete remission]
After complete remission, there is evidence of recurrence in pathology, and the imaging examination shows that the lesion recurs.
- recurrence time [2 years after complete remission]
Time of recurrence after complete remission.
- pregnancy rate [1 year after complete remission]
A pregnancy test shows pregnancy after complete remission.
- pregnancy time [1 year after complete remission]
Time of pregnancy.
- live birth rate [1 year after pregnancy]
The live birth rate is defined as the ratio of live births to pregnancies.
- CA125 [every 3-6 months until 5 years after initial treatment]
Used as a tumor marker for disease monitoring.
- HOMA-IR [every 3-6 months until 5 years after initial treatment]
Homeostasis model assessment of insulin resistance is used as an indicator to evaluate the level of insulin resistance.
- pathological markers [every 3-6 months until 5 years after initial treatment]
Immunohistochemical analysis is used to assess the expression of Ki-67, ER/PR, p53, PTEN, and mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6).
- adverse reactions [every 3-6 months until 5 years after initial treatment]
Harmful reactions unrelated to the purpose of treatment occur during normal prevention, diagnosis, and treatment of diseases.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hosoital | Beijing | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
- Peking University Third Hospital
- Peking Union Medical College Hospital
- Third Military Medical University
- Tianjin Medical University General Hospital
- Tongji Hospital
- Qilu Hospital of Shandong University
- Shengjing Hospital
- Beijing Chao Yang Hospital
- Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences
Investigators
- Study Director: Jianliu Wang, Professor, Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017ECFerSp