NCT07436793 · New Mexico Cancer Research Alliance
Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
Where
- Iowa City, Iowa
- Albuquerque, New Mexico
- Salt Lake City, Utah
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations