Actively Recruiting
Letrozole in Uterine Leiomyosarcoma
Led by GOG Foundation · Updated on 2026-03-31
40
Participants Needed
25
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Letrozole in Uterine Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and authorization to release personal health information
- Histologically confirmed newly diagnosed uterine leiomyosarcoma limited to the uterus (FIGO 2009 Stage I)
- Tumors must show estrogen receptor positivity greater than 10% by immunohistochemistry
- Completed hysterectomy and bilateral salpingo-oophorectomy within 12 weeks before enrollment
- No measurable disease as defined by RECIST 1.1 within 6 weeks prior to enrollment
- ECOG performance status of 0, 1, or 2
- Adequate organ and marrow function including ANC ≥1500 cells/mcl, platelets ≥100,000 cells/mcl, hemoglobin ≥9.0 g/dL, serum creatinine ≤1.5 x ULN, AST and ALT ≤3.0 x ULN, serum albumin ≥2.5 g/dL
- At least 18 years old
- Able to swallow oral medication
You will not qualify if you...
- Mixed malignant mullerian tumors or non-pure uterine sarcomas
- Severe concurrent diseases including significant hepatic, renal, or gastrointestinal conditions
- Concomitant invasive malignancy or history of malignancy within past 3 years except specified exceptions
- History of any aromatase inhibitor use within the past 5 years
- Active or uncontrolled systemic infection
- History of uncontrolled cardiac disease including uncontrolled hypertension, unstable angina, recent myocardial infarction, uncontrolled congestive heart failure, significant arrhythmias, or cardiomyopathy with ejection fraction under 40%
- Currently receiving chemotherapy or radiation therapy
- Severe hepatic impairment or cirrhosis
- Gastrointestinal disorders interfering with oral medication absorption
- Known hypersensitivity to letrozole excipients
- Pregnant or breastfeeding
- Participation in another investigational drug study within 30 days prior to enrollment
- Currently using systemic estrogens including herbals and supplements with estrogenic properties (vaginal estrogen permitted if needed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Highlands Ranch Hospital
Highlands Ranch, Colorado, United States, 80129
Actively Recruiting
3
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
4
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
5
Winship Cancer Institute, Emory Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Endeavor Health - Kellogg Cancer Center
Evanston, Illinois, United States, 60201
Actively Recruiting
7
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
9
WK Physician Network-Gynecologic Oncology Associates
Shreveport, Louisiana, United States, 71103
Actively Recruiting
10
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Actively Recruiting
11
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Actively Recruiting
13
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89511
Actively Recruiting
14
Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
15
Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
16
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
17
East Carolina University Health Medical Center
Greenville, North Carolina, United States, 27834
Actively Recruiting
18
OhioHealth Arthur G.H. Bing, MD Cancer Center
Columbus, Ohio, United States, 43214
Actively Recruiting
19
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
20
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
21
OhioHealth Grant Medical Center
Columbus, Ohio, United States, 43215
Actively Recruiting
22
OhioHealth Marion General Hospital
Marion, Ohio, United States, 43302
Actively Recruiting
23
University of Oklahoma Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
24
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
25
Woman and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
Research Team
S
Sarin Chhab
CONTACT
S
Shanon Matkin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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