Randomized Study Comparing Daily Letrozole Treatment to Observation in Women with Early-Stage Uterine Leiomyosarcoma

What this Trial Is About

Researchers are evaluating letrozole treatment in women newly diagnosed with uterine leiomyosarcoma, a type of cancer limited to the uterus. This randomized phase II study compares daily letrozole to observation to see if letrozole can extend the time patients remain free from disease progression. The main goal is to measure progression-free survival up to three years from randomization. Participants will be randomly assigned to receive either 2.5 mg of letrozole orally once daily or no treatment observation. The study includes patients with early-stage disease FIGO 2009 Stage I who have completed surgery with hysterectomy and bilateral salpingo-oophorectomy within 12 weeks before enrollment. The study uses adaptive randomization to assign patients to either group. During the trial, participants will be monitored regularly to detect any disease progression or death. The main measurement is the time from enrollment until progression or death. Participants must meet specific health criteria, including no measurable disease at enrollment and adequate organ function. The study will continue until July 2029, with primary outcome data collected up to three years after randomization.

Letrozole in Uterine Leiomyosarcoma