Clinical trial · Interventional
Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer
Phase II Study of Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Stage I Endometrial Adenocarcinoma With Grade 2 Differentiation or Superficial Myomectomy Invasion
NCT03567655CI-TRIAL-00033434unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This registry aims to evaluate the efficacy of using high-dose oral progestin in young women with stage I endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Farlutal tab. 500mg/ Pfizer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single group
- description
- Farlutal tab. 500mg/ Pfizer to be administered
- interventionNames
- Drug: Farlutal tab. 500mg/ Pfizer
Primary outcomes (1)
- measure
- complete response rate
- timeFrame
- 12 months of taking oral MPA
- description
- Patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion or patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium or patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion are administered medroxyprogesterone Acetate(MPA) at a dosage of 500 mg/day for 12 months.
Secondary outcomes (3)
- measure
- disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion based on Magnetic resonance image(MRI) * Patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium based on MRI * Patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion based on MRI * Patients who desire to preserve fertility potential * Patients signed the written informed consent voluntarily Exclusion Criteria: * Patients who have severe underlying disease or complication * Under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy * Acute liver disease or kidney disease * Thrombosis or phlebothrombosis requiring treatment, Hyperlipidemia, Smoker
References
Publications (4)
- BACKGROUNDPark JY, Nam JH. Progestins in the fertility-sparing treatment and retreatment of patients with primary and recurrent endometrial cancer. Oncologist. 2015 Mar;20(3):270-8. doi: 10.1634/theoncologist.2013-0445. Epub 2015 Feb 11. PMID 25673106
- BACKGROUNDBokhman JV, Chepick OF, Volkova AT, Vishnevsky AS. Can primary endometrial carcinoma stage I be cured without surgery and radiation therapy? Gynecol Oncol. 1985 Feb;20(2):139-55. doi: 10.1016/0090-8258(85)90135-0. PMID 3972284
- BACKGROUNDKempson RL, Pokorny GE. Adenocarcinoma of the endometrium in women aged forty and younger. Cancer. 1968 Apr;21(4):650-62. doi: 10.1002/1097-0142(196804)21:43.0.co;2-p. No abstract available. PMID 5643760
- BACKGROUNDSkouby SO. The rationale for a wider range of progestogens. Climacteric. 2000 Dec;3 Suppl 2:14-20. PMID 11379382