Table 1.
Current or ongoing clinical trials of conservative treatment for endometrial cancer (EC)
| ClinicalTrials. gov ID | Start date | Study title | Aims (primary objective) | Design/intervention | Institution | Participants |
|---|---|---|---|---|---|---|
| NCT02035787 | March 2014 | Metformin with the levonorgestrel-releasing intrauterine device for the treatment of complex atypical hyperplasia (CAH) and endometrial cancer (EC) in non-surgical patients | To compare the rate of CR at 6 months in non-surgical grade 1 EC and CAH patients receiving metformin + LNG-IUS to 50% | Open label/metformin 850 mg twice daily added to standard non-surgical treatment with LNG-IUS | Chapel Hill, NC, USA | 15 women 18 years or older with biopsy-proven complex atypical hyperplasia (n=15) or grade 1 EC |
| NCT01594879 | January 2012 | Treatment with medroxyprogesterone acetate plus LNG-IUS in young women with early stage endometrial cancer | To investigate the treatment efficacy of LNG-IUS plus MPA in young women with early stage EC | Phase 2 open label trial/Mirena® (LNG-IUD), oral MPA oral progestin + LNG-IUS | Korean Gynecologic Oncology Group Study | 39 patients <40 years of age with histologically confirmed as EC grade 1 that is confined to the endometrium based on the MRI evaluation |
| NCT00788671 | November 2008 | Levonorgestrel intrauterine device (IUD) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1EEC) | To learn the level of effectiveness of the Mirena® LNG-IUD in treating hyperplasia of the lining of the uterus and/or early-stage cancer of the lining of the uterus | Phase 2 open label trial/levonorgestrel IUD | M.D. Anderson Cancer Center, TX USA | 50 patients ≥18 with a diagnosis of complex atypical hyperplasia or endometrial biopsy within 3 months of study enrolment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma |
| NCT03241914 | July 2017 | Megestrol acetate plus LNG-IUS in young women with early endometrial cancer | To see if MA plus LNG-IUS will not be inferior to returning the endometrial tissue to a normal state than MA alone in patients with early EC | Phase 2 & 3 randomized trial/oral MA 160 mg/day vs. oral MA 160 mg/day + LNG IUS for at least 3 months | Fudan University, Shanghai | 40 patients 18-45 years of age; confirmed diagnosis of endometrioid EC based upon hysteroscopy; no myometrial invasion confirmed, extension beyond corpus, or enlarged lymph nodes confirmed by MRI |
| NCT02990728 | March 2016 | Mirena® ± metformin as fertility-preserving treatment for young Asian women with early endometrial cancer | To evaluate the efficacies of LNG-IUS, Mirena®, with or without metformin over ~6 month | Phase 2 randomized open label trial/Mirena® LNG-IUD vs. Mirena® LNG-IUD + Metformin | Chang Gung Memorial Hospital, Taiwan | 120 patients ≤40 years old with histologic confirmed grade 1 endometrioid EC; tumor confined to the endometrial cavity with no evidence of metastasis on MRI and/or TVUS |
| NCT02397083 | September 2015 | Levonorgestrel-releasing intrauterine system with or without everolimus in treating patients with atypical hyperplasia or stage IA grade 1 endometrial cancer | To estimate the efficacy of the LNG-IUS device alone and in combination with everolimus to treat complex atypical hyperplasia or stage Ia grade 1 endometrioid EC with response rate | Phase 2 randomized open label trial/LNG IUD vs. LNG IUS + everolimus | M.D. Anderson Cancer Center, TX USA | 270 patients ≥ 18 years of age with a diagnosis of CAH or grade1 endometrioid or focal grade 2 adenocarcinoma with predominantly grade 1 EC |
| NCT03463252 | April 2018 | Value of LNG-IUS as fertilitypreserving treatment of EAH and EC | To analyze the effectiveness of LNG-IUS (Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early EC, including pathology response and pregnancy outcome | Phase 2 & 3 randomized open label trial/MPA 250–500 mg/day vs. MPA+LNG-IUS vs. LNG-IUS only; patients with contraindication to oral MPA is allocated to GnRH-agonist | West China Second University Hospital | 224 patients ≤40 years old with a grade 1 endometrioid EC limited to the endometrium on MRI; and a strong desire for fertility preservation |
| NCT03077698 | June 2017 | An endometrial cancer study for women with recurrent or persistent endometrial cancer | To investigate the efficacy of sodium cridanimod in conjunction with progestin therapy in patients with recurrent or persistent EC, who have failed progestin monotherapy or who have been identified as PrR negative | Phase 2 open label multi-center trial/sodium cridanimod in conjunction with MA therapy | Xenetic Biosciences, Inc | 72 patients ≥18 years of age with histologically confirmed serous carcinoma or endometrioid type of EC; recurrent or persistent progressive disease that is refractory to established treatments |
| NCT03538704 | January 2015 | Effect of fertility-sparing therapy of early endometrial cancer | The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer | Randomized open label trial/BMI ≥25 kg/m2 given MPA 250 mg/day plus Metformin 1–1.5 g/day vs. MPA 250 mg/day only | Peking University People’s Hospital | 80 patients 18 to 40 years old with FIGO stage 1a grade 1 with lesion confined to the endometrium; strong desire to preserve fertility |
| NCT01968317 | October 2013 | Megestrol acetate plus metformin to megestrol acetate in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma | To evaluate efficacy of MA plus metformin in returning the endometrial tissue to a normal state than MA alone in patients with endometrial atypical hyperplasia or early stage EC | Phase 2 randomized open label/oral metformin 500 mg third daily + MA 160 mg/day vs. MA 160 mg/day for 3 months | Fudan University, Shanghai | 150 patients 18–45 years old with a confirmed diagnosis of endometrial atypical hyperplasia or low grade EC; desire for reproductive function or uterus |
| NCT04008563 | August 2019 | Bariatric surgery for fertilitysparing treatment of atypical hyperplasia and grade 1 cancer of the endometrium (B-FiERCE) | To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥40% recruitment rate is achieved patients’ reasons for participation or non-participation will be recorded | A pilot randomized controlled trial to assess the feasibility of a full-scale randomized trial. participants will be randomized 1:1 to bariatric surgery plus pIUD or standard pIUD alone | University Health Network, Toronto | 36 patients 18–41 years old with grade 1 endometrioid EC or complex atypical hyperplasia, and BMI ≥35 kg/m2, no evidence of metastatic disease, a desire for fertility preservation and no contraindications to pIUD |
BMI, body mass index; CR, complete response; EC, endometrial cancer; EAH, atypical endometrial hyperplasia; FIGO, International Federation of Gynecology and Obstetrics; CAH, complex atypical hyperplasia; GnRH, gonadotropin-releasing hormone; PrR, progesterone receptor; LNG-IUS, levonorgestrel-releasing intrauterine system; LNG-IUD, levonorgestrel-releasing intrauterine device; MA, megestrol acetate; MPA, medroxyprogesterone acetate; MRI, magnetic resonance imaging; IUD, intrauterine device; pIUD, progestin intrauterine device.