NCT07436793 Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial
| NCT ID | NCT07436793 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | New Mexico Cancer Research Alliance |
| Condition | Endometrial Endometrioid Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2026-06-15 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial tests compares the effect of progestins, megestrol acetate to micronized progesterone, in treating patients with endometrial cancer and precancers of the uterus (atypical endometrial hyperplasia) before surgery. Progestins, similar to the natural hormone progesterone, are approved drugs used in birth control and hormone replacement pills, and some can treat uterine endometrial cancers. In the initial comparison of this rotating umbrella trial, megestrol acetate, a progestin, will be compared to micronized progesterone, a form of natural progesterone that is a hormone produced by body normally. Hormone therapy using megestrol acetate and micronized progesterone may be effective in treating patients with endometrial cancer or atypical endometrial hyperplasia before surgery, and understanding the tissue effects of each agent on the malignant endometrium will uncover novel mechanistic and biomarker data to understand how best to advanced hormone therapy for endometrial cancer.
Eligibility Criteria
Inclusion Criteria: * Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks prior to registration. Pathology reports should document adequate tissue from the biopsy and slides should be reasonable determined to be obtainable by the study team for study use * History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1) * Age ≥ 18 * The trial is open only to women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) who are planned and appropriate for primary surgical treatment to include removal of the uterine corpus via any surgical modality. The patient must be considered a suitable surgical candidate * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 within 28 days prior to registration * Formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage must be reasonably deemed available for submission along with the corresponding pathology report * Platelets ≥ 100,000/μl * Granulocytes (absolute neutrophil count \[ANC\]) ≥ 1,500/μl * Creatinine ≤ 1.6 mg/dl * Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \[ALT\]) ≤ 3 x upper limits of normal * Bilirubin within institutional normal limits * The patient must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry * Any patients of childbearing potential must have a negative pregnancy test Exclusion Criteria: * Patients with any non-endometrioid histology (such as serous, clear cell, or carcinosarcoma or mixed) * Patients who have received prior progestin or anti-estrogen therapy during the 3 months before the diagnosis of endometrioid adenocarcinoma of the uterine corpus is established. Estrogen therapy alone is allowed * Patients with ECOG performance status of 4 * Patients with history of deep venous thrombosis or pulmonary embolism within the past 2 years or ongoing thromboembolic disorders * Patients who have previously received systemic, radiation or other treatment for uterine cancer * Patients for whom formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage is scant or unavailable * Patients with a suspected or known peanut allergy * Patients with serious comorbidities or gastrointestinal obstruction that precludes taking oral medications or have malabsorptive disease
Contact & Investigator
Carolyn Y Muller
PRINCIPAL INVESTIGATOR
University of New Mexico Cancer Center
Frequently Asked Questions
Who can join the NCT07436793 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Endometrioid Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07436793 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07436793 currently recruiting?
Yes, NCT07436793 is actively recruiting participants. Visit ClinicalTrials.gov or contact New Mexico Cancer Research Alliance to inquire about joining.
Where is the NCT07436793 trial being conducted?
This trial is being conducted at Iowa City, United States, Albuquerque, United States, Salt Lake City, United States, Charlottesville, United States.
Who is sponsoring the NCT07436793 clinical trial?
NCT07436793 is sponsored by New Mexico Cancer Research Alliance. The principal investigator is Carolyn Y Muller at University of New Mexico Cancer Center. The trial plans to enroll 140 participants.