Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

Официальное название

Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma

Обзор

Primary end points: This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome. Second end points: To analyze the appearances of side-effects.

Вмешательства

• Препарат Progesterone
  MPA oral 250mg-500mg qd for 3 months per cycle
• Устройство Mirena®
  levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle
• Препарат GnRH agonist
  GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle

Первичные конечные точки

• Pathologic Response [Срок оценки: 6-12 months]
• Pregnancy Rate [Срок оценки: 7-144 months]
• Live Birth Rate [Срок оценки: 16-144 months]

Вторичные конечные точки (1)

• Side-Affects Rate [Срок оценки: 1-144 months]

Критерии участия

For Patients With Endometrial Cancer：

Критерии включения

• ≤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.

Критерии исключения

• 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：

Критерии включения

• ≤ 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Second University Hospital — Чэнду

Публикации

• 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) PMID 17602085
• Rodolakis A, Biliatis I, Morice P, Reed N, Mangler M, Kesic V, Denschlag D. European Society of Gynecological Oncology Task Force for Fertility Preservation: Clinical Recommendations for Fertility-Sparing Management in Young Endometrial Cancer Patients. Int J Gynecol Cancer. 2015 Sep;25(7):1258-65. doi: 10.1097/IGC.0000000000000493. PMID 26186070
• Minig L, Franchi D, Boveri S, Casadio C, Bocciolone L, Sideri M. Progestin intrauterine device and GnRH analogue for uterus-sparing treatment of endometrial precancers and well-differentiated early endometrial carcinoma in young women. Ann Oncol. 2011 Mar;22(3):643-649. doi: 10.1093/annonc/mdq463. Epub 2010 Sep 28. PMID 20876910
• KELLEY RM, BAKER WH. Progestational agents in the treatment of carcinoma of the endometrium. N Engl J Med. 1961 Feb 2;264:216-22. doi: 10.1056/NEJM196102022640503. No abstract available. PMID 13752346
• Zhang Q, Qi G, Kanis MJ, Dong R, Cui B, Yang X, Kong B. Comparison among fertility-sparing therapies for well differentiated early-stage endometrial carcinoma and complex atypical hyperplasia. Oncotarget. 2017 May 3;8(34):57642-57653. doi: 10.18632/oncotarget.17588. eCollection 2017 Aug 22. PMID 28915701
• Wildemeersch D, Andrade A, Goldstuck N. Femilis((R)) 60 Levonorgestrel-Releasing Intrauterine System-A Review of 10 Years of Clinical Experience. Clin Med Insights Reprod Health. 2016 Aug 9;10:19-27. doi: 10.4137/CMRH.S40087. eCollection 2016. PMID 27547046
• Karimi-Zarchi M, Dehghani-Firoozabadi R, Tabatabaie A, Dehghani-Firoozabadi Z, Teimoori S, Chiti Z, Miratashi-Yazdi A, Dehghani A. A comparison of the effect of levonorgestrel IUD with oral medroxyprogesterone acetate on abnormal uterine bleeding with simple endometrial hyperplasia and fertility preservation. Clin Exp Obstet Gynecol. 2013;40(3):421-4. PMID 24283179
• Gallos ID, Shehmar M, Thangaratinam S, Papapostolou TK, Coomarasamy A, Gupta JK. Oral progestogens vs levonorgestrel-releasing intrauterine system for endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010 Dec;203(6):547.e1-10. doi: 10.1016/j.ajog.2010.07.037. PMID 20934679

Идентификаторы

NCT: NCT03463252 · ZHENG Ying

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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