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

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 produc

Trial Details

NCT ID
NCT07436793
Phase
PHASE2
Sponsor
New Mexico Cancer Research Alliance
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • Biopsy Procedure
  • Curettage Procedure
  • Hysterectomy
  • Megestrol Acetate
  • Progesterone Only Hormone Replacement Therapy
Locations (sample)
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Albuquerque, New Mexico, United States|35.08449,-106.65114
  • Salt Lake City, Utah, United States|40.76078,-111.89105
  • Charlottesville, Virginia, United States|38.02931,-78.47668

Key Eligibility Criteria

  • Patients must have a histologically proven diagnosis of endometrioid endometrial adenocarcinoma by endometrial curettage or biopsy within 8 weeks p…
  • History/physical examination within 42 +/- 5 days of planned surgical procedure (18-21 days from day 1)
  • The trial is open only to women with primary endometrioid adenocarcinoma of the uterine corpus (all histologic grades and stages) who are planned a…
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3 within 28 days prior to registration

For full eligibility, visit ClinicalTrials.gov.

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