Clinical trial · Interventional
Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer
The Effect of Megestrol Acetate on Grade 2 Endometrioid Endometrial Cancer in Patients Waiting for Definitive Surgery, a Prospective Trial
NCT05332483CI-TRIAL-00071048MA-EECterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow enrollment
Summary
Brief summary (as posted)
This is a single centre, single arm, open label, preoperative window of opportunity study. Grade 2 endometrioid endometrial carcinoma patients awaiting surgery will be prospectively recruited to receive a pre-operative progestin therapy course. Therapy response will be histologically evaluated and correlated with clinical and molecular data by comparison of responders vs. non-responders pre- and post-treatment tumor samples.
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 |
|---|---|---|---|
| Megestrol Acetate | Drug | Megestrol | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1 - Megestrol
- description
- All study participants will receive Megestrol acetate, 160 mg daily (two 40mg tablets twice a day), for a minimum of 18 days.
- interventionNames
- Drug: Megestrol Acetate
Primary outcomes (1)
- measure
- Overall response rate of patients with biopsy grade 2 endometrioid endometrial cancer treated preoperatively with Megestrol acetate for a minimum of 21 days.
- timeFrame
- 2 years
- description
- Tumor response will be strictly histologically defined. Surgical specimens of each patient will be grossed in the pathology department as per standard of care. The degree of tumor response will be defined as follows: * Complete response: resolution of both cytologic atypia and architectural complexity to resemble non-tumorous endometrium. * Partial response: resolution of cytologic atypia and/or decrease in tumor grade (ie. From FIGO grade 2 to FIGO grade 1) * No response: persistence of the original lesion or progression to higher tumor grade.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult female patient 18 years of age or older. * Confirmed diagnosis of FIGO grade 2 endometrioid endometrial cancer on preoperative endometrial biopsy read by a pathologist with a subspecialty in gynecologic pathology. * Stage 1 endometrioid endometrial cancer on preoperative endometrial biopsy. * P53 wild type immunohistochemistry on preoperative endometrial biopsy. * Patients eligible for primary staging surgery for definitive treatment for their cancer. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Required Initial Laboratory Values obtained within 3 days of enrolment following standard of care protocols: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet Count ≥ 100,000/mm3; eGFR ≥ 60 mL/min/1.73m2; Total Bilirubin ≤ 1.5 x upper limit of normal (ULN); AST / ALT ≤ 2.5 x upper limit of normal (ULN). * Informed consent for this study is obtained and signed by the participant or have an acceptable Substitute Decision Maker (SDM) capable of signing the informed consent form on behalf of the participant. Exclusion Criteria: * Patients cannot be receiving systemic or hormonal therapy for treatment of the endometrial cancer. * Prior radiation therapy for treatment of the endometrial cancer is not allowed. * Stage 2 or 3 endometrioid endometrial cancer on preoperative endometrial biopsy. * Abnormal p53 immunohistochemistry on preoperative endometrial biopsy. * History of an allergic reaction to medroxyprogesterone acetate. * History of venous thromboembolic event (including previous deep vein thrombosis or pulmonary embolism). * Family history of venous thromboembolic event. * Have a \>20 pack-year smoking history. * Patients unwilling or unable to follow the study protocol schedule.
References
Publications (0)
Data not yet available
No reference posted for this study.