Table 2.
Currently ongoing studies of different conservative management options in women with endometrial cancer.
| CT Identifier | Recruitment Criteria | Response Markers | Intervention | Status | Primary Completion |
|---|---|---|---|---|---|
| NCT03804463 | Women with EC up to 50 years of age, with EC Stage IA G1 or G2, normal CA125 | Histology and recurrence free survival | radical surgery vs. endometrectomy vs. histerectomy with ovarian preservation | Not yet recruiting | January 2019 |
| NCT03538704 | EC up to 40 years of age, Stage IA G1 or G2 | Complete pathological response and fertility, RFS | MPA or MPA + metformin | Recruiting | March 2020 |
| NCT02990728 | EC from 20–40 years of age, Stage IA G1, no imaging signs of adenomyosis or ovarian endometriosis, normal CA125 | Histology and markers: progesteron A and B receptors, estrogen, Ki7, PTEN, Bcl2 | Mirena vs. Mirena + Metformin | Unknown | March 2018 |
| NCT03567655 | EC from 20–40 years of age, Stage IA G1 or G2 with superficial invasion | Histology and recurrence free survival | MPA | Not yet recruiting | October 2022 |
| NCT04362046 | EC from 19–39 years of age and Stage IA G1, up to 1/3 of myometrial invasion and AEH | Local/distant disease and fertility outcomes | 6 months of high-dose progestin and then hysteroscopic resection | Not yet recruiting | May 2026 |
| NCT04008563 | EC from 18–41 years of age and Stage I, G1 or AEH and BMI ≥ 35, no signs of disease beyond uterus | Patient reported outcomes and complete response rate vs. LNG-IUS alone | Mirena and bariatric surgery vs. Mirena | Not yet recruiting | August 2022 |
| NCT04046185 | EC from 18–45 years of age and early EC | Histology and fertility outcomes | PD-1 inhibitor (toripalimab) every 3 weeks and megestrol acetate vs. megestrol acetate alone | Not yet recruiting | October 2022 |
| NCT03463252 | EC up to 40 years of age, Stage IA, G1 with positive progesterone receptors or AEH, no Lynch syndrome | Histology and fertility outcomes | randomized study of MPA only or MPA + LNG-IUS or GnRH-a + LNG-IUS or LNG-IUS only for EC or AEH | Recruiting | December 2019 |
| NCT01594879 [55] | EC up to 40 years of age, Stage IA, G1without myometrial invasion | Treatment response rate and diagnostic accuracy | Combined oral MPA/LNG-IUS treatment and evaluation of hysteroscopy vs. D&C for follow up | Unknown | December 2014 |
| NCT01686126 [56] | EC from 18 years of age wishing to retain fertility or unfit candidate for surgery due to comorbidity with Stage IA G1 EC or AEH, normal CA125 | Complete histological response, secondary: serum and molecular markers | LNG-IUS + Metformin, LNG-IUS + weight loss, LNG-IUS alone | Active, not recruiting | August 2020 |
| NCT03241914 | Stage I EC with no deep myometrial invasion in patients between 18 and 45 years of age | Pathological response rate | Megestrol acetate alone vs. megestrol acetate and LNG-IUS | Recruiting | July 2020 |
| NCT00788671 | Stage IA EC, G1 or AEH with fertility preservation wish or comorbidities preventing safe surgery | Pathological response rate, IHC, estrogen and Wnt signaling response | LNG-IUS placement | Active, not recruiting | November 2020 |
| NCT02035787 | Stage IA EC, G1 or AEH with fertility preservation wish or comorbidities preventing safe surgery | Pathological response | LNG-IUS + Metformin | Recruiting | December 2022 |
| NCT02397083 | Pre- and post-menopausal women with Stage IA EC, G1 or AEH | Pathological response | LNG-IUS alone or LNG-IUS with mTOR inhibitor everolimus | Recruiting | September 2026 |
Information valid as of 25 October 2020 based on ClinicalTrials.gov registry.