Shenyang Women's and Children's Hospital, No. 87, Renao Road, Danan Street, Shenhe District, Shenyang, Liaoning, China.
Reprod Health. 2022 Nov 4;19(1):206. doi: 10.1186/s12978-022-01513-8.
Endometrial adenocarcinoma (EC) is the fifth most common cancer in women worldwide, standard treatment for EC includes hysterectomy, but it results in the loss of reproductive function. Thus, conservative treatment for these patients is strongly demanded, progestin therapy is widely accepted as the main fertility-sparing treatment for young women with endometrial hyperplasia with atypia (EHA) and well-differentiated endometrioid endometrial cancer. This trial will investigate the effectiveness of conservative treatment for obese women with early-stage EC.
This will be an open-label, 2-armed, randomized, phase-II single-center trial of LNG-IUD plus metformin or megestrol acetate (MA) plus metformin. A total of 88 participants will be randomly assigned into 2 treatment arms in a 1:1 ratio. Clinical, laboratory, ultrasound and radiology data, will be collected at baseline, and then at 3, 6, 9, 12, 18, and 24 months. EC biomarkers will be collected at baseline. The primary aim is to determine the efficacy of a levonorgestrel-releasing intrauterine device (LNG-IUD) plus metformin, or megestrol acetate (MA) plus metformin in achieving pathological complete response (pCR) at 12 months, as well as post-treatment pregnancy outcomes and recurrence rate. The secondary aims are to predict the response to an LNG-IUD plus metformin and MA plus metformin via clinical, blood, and tissue predictive biomarkers.
Prospective evidence for conservative treatment of EC is limited. New methods to achieve better CR rates with fewer side effects are needed. This trial will investigate the effectiveness of LNG-IUD plus metformin, and MA plus metformin, in obese women with early-stage EC, providing a non-surgical treatment option for these patients. Trial registration ChiCTR2200055624. The trial was registered at http://www.chictr.org.cn/listbycreater.aspx on January 15, 2022.
子宫内膜腺癌（EC）是全球女性中第五大常见癌症，EC 的标准治疗包括子宫切除术，但这会导致生殖功能丧失。因此，强烈需要为这些患者提供保守治疗，孕激素治疗被广泛接受为有非典型子宫内膜增生（EHA）和分化良好的子宫内膜样子宫内膜癌的年轻女性的主要保留生育力治疗。本试验将研究保守治疗肥胖早期 EC 患者的效果。
这将是一项开放标签、2 臂、随机、二期单中心试验，比较左炔诺孕酮宫内节育系统（LNG-IUD）加二甲双胍或醋酸甲地孕酮（MA）加二甲双胍。总共 88 名参与者将以 1:1 的比例随机分配到 2 个治疗组。临床、实验室、超声和影像学数据将在基线时收集，然后在 3、6、9、12、18 和 24 个月时收集。基线时收集 EC 生物标志物。主要目的是确定 LNG-IUD 加二甲双胍或 MA 加二甲双胍在 12 个月时达到病理完全缓解（pCR）的疗效，以及治疗后妊娠结局和复发率。次要目的是通过临床、血液和组织预测生物标志物预测对 LNG-IUD 加二甲双胍和 MA 加二甲双胍的反应。
EC 的保守治疗的前瞻性证据有限。需要寻找新的方法来实现更好的 CR 率，同时减少副作用。本试验将研究 LNG-IUD 加二甲双胍和 MA 加二甲双胍在肥胖早期 EC 女性中的疗效，为这些患者提供一种非手术治疗选择。试验注册 ChiCTR2200055624。试验于 2022 年 1 月 15 日在 http://www.chictr.org.cn/listbycreater.aspx 注册。
