Study on Progestins for Treating Endometrial Cancer or Precancers of the Uterus Before Surgery (The Pro-Window Trial)
Sponsor: New Mexico Cancer Research Alliance
ClinicalTrials ID:NCT07436793
This clinical trial is comparing two hormone treatments, megestrol acetate and micronized progesterone, to see how well they work in treating endometrial cancer and precancerous conditions of the uterus before surgery.
Patient Parameters
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Program Overview
This study is testing two hormone treatments, megestrol acetate and micronized progesterone, to see which is more effective in treating endometrial cancer and precancerous conditions of the uterus before surgery. Both treatments are similar to the natural hormone progesterone and are already used in birth control and hormone replacement therapies. The trial aims to understand how these treatments affect cancerous tissues and to gather information that could improve hormone therapy for endometrial cancer.
Description
The main goals of this study are to test the effectiveness of hormone treatments called progestins in women with newly diagnosed endometrial cancer or precancerous conditions of the uterus. Researchers will also look for specific markers in the tissue that show how well the treatments are working.
Participants will be randomly assigned to one of two groups:
- Group 1: Participants will have a biopsy or tissue sample taken and then take megestrol acetate by mouth twice a day for 21-24 days before having surgery to remove the uterus.
- Group 2: Participants will have a biopsy or tissue sample taken and then take micronized progesterone by mouth once a day for 21-24 days before having surgery to remove the uterus.
After the treatment, participants will have a follow-up visit 30-45 days after surgery to check on their recovery and the effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of endometrial cancer or precancerous condition through a biopsy within the last 8 weeks.
- Must have a physical exam within 42 days of planned surgery.
- Must be 18 years or older.
- Only women with primary endometrial cancer who are suitable for surgery to remove the uterus can participate.
- Must have a performance status score of 0, 1, 2, or 3, indicating varying levels of activity.
- Must have tumor tissue available from the biopsy for study purposes.
- Must have adequate blood cell counts and organ function as determined by specific tests.
- Must provide informed consent and agree to the study's requirements.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Cannot have other types of uterine cancer, such as serous or clear cell cancer.
- Cannot have had hormone treatments like progestins or anti-estrogens in the last 3 months.
- Cannot have a performance status score of 4, indicating severe disability.
- Cannot have had blood clots in the last 2 years or ongoing clotting disorders.
- Cannot have had previous treatments for uterine cancer.
- Cannot have insufficient tumor tissue available from the biopsy.
- Cannot have a peanut allergy.
- Cannot have serious health conditions that prevent taking oral medications.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Iowa/Holden Comprehensive Cancer Center | 52242 | Iowa City | Iowa |
| University of New Mexico Cancer Center | 87106 | Albuquerque | New Mexico |
| University of Utah Sugarhouse Health Center | 84106 | Salt Lake City | Utah |
| University of Virginia Cancer Center | 22908 | Charlottesville | Virginia |
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