Value of LNG-IUS as Fertility-preserving Treatment of EAH... | NCT03463252

NCT03463252

Protocol Section

Identification Module

Results Section

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Annotation Section

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No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MPA for EC without progesterone contraindication	Active Comparator	The enrolled patient (endometrial cancer without contraindication of oral high dose progesterone) is allocated to one of three groups, MPA only, MPA+LNG-IUS, LNG-IUS only, by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if endometrial cancer is still present after 3 cycles.	Drug: Progesterone
MPA+Mirena® for EC without contraindication	Experimental	The enrolled patient (endometrial cancer without contraindication of oral high dose progesterone) is allocated to one of three groups, MPA only, MPA+LNG-IUS, LNG-IUS only, by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if endometrial cancer is still present after 3 cycles.	Drug: Progesterone Device: Mirena®
Mirena® for EC without contraindication	Experimental	The enrolled patient (endometrial cancer without contraindication of oral high dose progesterone) is allocated to one of three groups, MPA only, MPA+LNG-IUS, LNG-IUS only, by randomization. Continuous treatment for 3 months is one cycle. Hysteroscopic evaluation and biopsy will procedure every cycle. Patients with partial response or in stable condition, after 2 cycles, will receive continuous treatment for one more cycle again. Patients with complete response after 2 or 3 cycles are encouraged to pregnancy. The consideration of giving up fertility-sparing treatment is recommended: 1) if patient have documented progression on the biopsies; 2) if endometrial cancer is still present after 3 cycles.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Drug	MPA oral 250mg-500mg qd for 3 months per cycle	MPA for EAH without progesterone contraindication MPA for EC without progesterone contraindication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathologic Response	Pathologic response to medicine treatment is categorized as complete response (CR), partial response (PR), no change (NC), and progressive disease (PD). CR is defined as the absence of any hyperplastic or cancerous lesion. PR is defined as the residual lesion with degeneration and atrophy of endometrial glands. NC is defined as residual lesion without degeneration or atrophy of endometrial glands. PD is defined as the appearance of endometrial cancer for EAH and grade 2 (G2) or 3 for EC.	6-12 months
Pregnancy Rate	The percentage of successful pregnancies in the CR patients.	7-144 months
Live Birth Rate	The percentage of successfully alive baby delivery in the pregnant patients.	16-144 months

Secondary Outcomes

Measure	Description	Time Frame
Side-Affects Rate	The appearances of side-effects include weight gain, irregular vaginal bleeding, breast pain, appetite changes, nausea, vomiting, rash, jaundice, thromboembolism, hypertension, liver dysfunction, kidney dysfunction, glucose intolerance, and diabetes.	1-144 months

Eligibility Module

Eligibility Criteria

For Patients With Endometrial Cancer：

Inclusion Criteria:

≤40 years of age:
Having a strong desire for fertility preservation;
Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;
Disease limited to the endometrium (stage 1A) on MRI;
Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);
Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.

Exclusion Criteria:

Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;
Patients have lynch syndrome (LS);
Patients have contraindications for pregnancy;
Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);
Patients refuse to participate in clinical follow-up or sign the informed consent form.

For Patients With Endometrial atypical hyperplasia：

Inclusion Criteria:

≤ 40 years of age
Having a strong desire for fertility preservation
Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists
Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up

Exclusion Criteria:

Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs
Patients have contraindications for pregnancy
Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)
Patients refuse to participate in clinical follow-up or sign the informed consent form.

Name	Role	Phone	Extension	Email
ZHENG Ying, Professor	Contact	+8613018256012		935398163@qq.com
CHEN Si Jing, postgraduate	Contact	+86218380361314		Zhy_chd@126.com

Facility	Status	City	State	ZIP	Country	Contacts
West China Second University Hospital	Recruiting	Chengdu	Sichuan	610000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17602085	Background	Ushijima K, Yahata H, Yoshikawa H, Konishi I, Yasugi T, Saito T, Nakanishi T, Sasaki H, Saji F, Iwasaka T, Hatae M, Kodama S, Saito T, Terakawa N, Yaegashi N, Hiura M, Sakamoto A, Tsuda H, Fukunaga M, Kamura T. Multicenter phase II study of fertility-sparing treatment with medroxyprogesterone acetate for endometrial carcinoma and atypical hyperplasia in young women. J Clin Oncol. 2007 Jul 1;25(19):2798-803. doi: 10.1200/JCO.2006.08.8344.
26186070

ID	Term
D016889	Endometrial Neoplasms
D004714	Endometrial Hyperplasia

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

ID	Term
D011374	Progesterone
D017258	Medroxyprogesterone Acetate
D007987	Gonadotropin-Releasing Hormone
C090784	ricin A-GnRH conjugate

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473