A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
GOG Foundation
Summary
This is a clinical trial to test letrozole in patients with uterine leiomyosarcoma. The main question is will treatment with letrozole extend progression-free survival in patients. Patients will receive 2/5 mg of letrozole daily.
Description
This is a randomized phase II study of letrozole (Femara) administered 2.5 mg orally daily to patients with newly diagnosed clinical stage I and II LMS. Using an adaptive randomization, patients will be assigned to either the treatment arm (letrozole group) or observation. The primary outcome for this trial is the time to progression.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information. 2. Patient must have histologically confirmed newly diagnosed uterine leiomyosarcoma with disease limited to the uterus (FIGO 2009 Stage I). Submission of pathology report documenting uterine leiomyosarcoma histology is required in the IRT Source Document Portal following randomization. 3. Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemist…
Interventions
- DrugLetrozole
Letrozole 2.5 mg PO daily
Locations (25)
- University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado
- Highlands Ranch HospitalHighlands Ranch, Colorado
- Broward Health Medical CenterFort Lauderdale, Florida
- Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
- Winship Cancer Institute, Emory HospitalAtlanta, Georgia
- Endeavor Health - Kellogg Cancer CenterEvanston, Illinois