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Progestins for the Treatment of Endometrial Cancer or Precancers of the Uterus Before Surgery, The Pro-Window Trial
Sponsor: New Mexico Cancer Research Alliance
Summary
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.
Official title: Evaluating Promising Progestins in Endometrial Cancer Through a Rotating Umbrella Surgical Window Trial - The PRO-WINDOW TRIAL for Endometrial Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-03-01
Completion Date
2031-06-30
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Biopsy Procedure
Undergo biopsy
Curettage Procedure
Undergo curettage
Hysterectomy
Undergo hysterectomy
Megestrol Acetate
Given PO
Progesterone Only Hormone Replacement Therapy
Given PO
Locations (4)
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
University of Utah Sugarhouse Health Center
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States