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New treatment option for Endometrial Endometrioid Adenocarcinoma
Official title Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial
ClinicalTrials.gov ID: NCT07436793
What this study is testing
What is Megestrol Acetate?
Megestrol Acetate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for endometrial endometrioid adenocarcinoma.
Also referred to as 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate, 17.alpha.-Acetoxy-6-methylpregna-4,6-diene-3,20-dione.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks...
- 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...
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 within 28 days prior to registration
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
- Albuquerque, New Mexico, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States; Albuquerque, New Mexico, United States; Salt Lake City, Utah, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.