Progestins before surgery for endometrial cancer or precancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this adaptive, master protocol, women with newly diagnosed endometrioid endometrial cancer or atypical endometrial hyperplasia are randomized to receive either megestrol acetate or micronized progesterone for about three weeks before their planned hysterectomy. Tissue samples collected before and after treatment will be analyzed to identify biomarkers and molecular signatures associated with progestin response. The goal is to understand how these hormones affect the malignant endometrium and to guide future hormone-therapy strategies."

Why it matters

Who can join: the full rules

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

Where it's running

• University of Iowa/Holden Comprehensive Cancer Center
  Iowa City, Iowa, United States Recruiting
• University of New Mexico Cancer Center
  Albuquerque, New Mexico, United States Recruiting
• University of Utah Sugarhouse Health Center
  Salt Lake City, Utah, United States Not yet recruiting
• University of Virginia Cancer Center
  Charlottesville, Virginia, United States Not yet recruiting

Study contacts

• Principal investigator: Carolyn Y Muller — University of New Mexico Cancer Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.