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โ† Trials
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Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial

RecruitingPhase 2Ages 18 Years - anyFemaleNew Mexico Cancer Research Alliance
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In plain words

What the trial is, and whether it could suit you

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 nove

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 100,000/ฮผl * Granulocytes (absolute neutrophil count \[ANC\]) โ‰ฅ 1,500/ฮผl * Creatinine โ‰ค 1.6 mg/dl * Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \[ALT\]) โ‰ค 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
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What it tests

  • Biopsy Procedure
  • Curettage Procedure
  • Hysterectomy
  • Megestrol Acetate
  • Progesterone Only Hormone Replacement Therapy
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Where

4 sites
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, United States
University of New Mexico Cancer Center
Albuquerque, United States
University of Utah Sugarhouse Health Center
Salt Lake City, United States
University of Virginia Cancer Center
Charlottesville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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