NCT07436793RecruitingPhase 2
Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial
Evaluating Promising Progestins in Endometrial Cancer Through a Rotating Umbrella Surgical Window Trial - The PRO-WINDOW TRIAL for Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- New Mexico Cancer Research Alliance
- Diseases
- Endometrial cancer
- NCT number
- NCT07436793
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 15 Jun 2026 to the primary completion date, 30 Jun 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who have previously received systemic, radiation or other treatment for uterine cancer
Other illness
- Patients with history of deep venous thrombosis or pulmonary embolism within the past 2 years or ongoing thromboembolic disorders
- Patients with a suspected or known peanut allergy
- Patients with serious comorbidities or gastrointestinal obstruction that precludes taking oral medications or have malabsorptive disease
Other
- Patients with any non-endometrioid histology (such as serous, clear cell, or carcinosarcoma or mixed)
- Patients with ECOG performance status of 4
- Patients for whom formalin-fixed, paraffin-embedded tumor tissue from the biopsy or curettage is scant or unavailable
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Not yet recruiting |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| University of Utah Sugarhouse Health Center Coordinator of this site? Confirm its status | Salt Lake City | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.