Actively Recruiting
A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
Led by GOG Foundation · Updated on 2026-03-31
40
Participants Needed
25
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating letrozole in patients diagnosed with uterine leiomyosarcoma, a type of cancer limited to the uterus. This randomized phase II study aims to determine if daily treatment with letrozole can extend the time patients live without their disease getting worse. The study compares patients receiving letrozole treatment to those under observation without active treatment. Participants will be randomly assigned to one of two groups: one receiving 2.5 mg of letrozole orally each day, and the other group undergoing observation without medication. The study focuses on patients with newly diagnosed stage I or II uterine leiomyosarcoma who have undergone surgery. Treatment is planned to continue with daily dosing and monitoring for disease progression. During the trial, participants will have regular assessments to monitor their health and cancer status, including evaluations of progression-free survival measured from enrollment up to three years. Researchers will also monitor safety and organ function through laboratory tests and clinical exams. Participants are followed closely for changes in their disease, with the goal of understanding how letrozole affects progression over time.
CONDITIONS
Brief Title
Letrozole in Uterine Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and authorization for release of personal health information
- Histologically confirmed newly diagnosed uterine leiomyosarcoma limited to the uterus (FIGO 2009 Stage I)
- Tumors must be estrogen receptor (ER) positive with over 10% expression by immunohistochemistry
- Completed hysterectomy and bilateral salpingo-oophorectomy within 12 weeks prior to enrollment
- No measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment
- ECOG performance status of 0, 1, or 2
- Adequate bone marrow, renal, and hepatic function as specified
- At least 18 years of age
- Able to swallow oral medication
You will not qualify if you...
- Presence of mixed malignant mullerian tumors or non-pure uterine sarcomas
- Severe concurrent diseases including significant liver, kidney, or gastrointestinal disorders
- History of invasive malignancy or prior cancer unless disease-free for at least three years
- Use of any aromatase inhibitor in the past 5 years
- Active or uncontrolled systemic infection
- Uncontrolled cardiac disease including hypertension, angina, recent heart attack, heart failure, arrhythmias, or low ejection fraction
- Current chemotherapy or radiation therapy
- Severe liver impairment or cirrhosis
- Gastrointestinal conditions interfering with oral medication absorption
- Known allergy to letrozole ingredients
- Pregnancy or breastfeeding
- Participation in another clinical trial with investigational drugs within 30 days prior to enrollment
- Current use of systemic estrogens including herbal or supplements with estrogenic properties (vaginal estrogen allowed if needed)
- Clinically unfit for trial as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years or until disease progression or discontinuation
Participants receive letrozole 2.5 mg orally once daily or are observed without active treatment, depending on random assignment.
Regular visits for medication dispensing and monitoring as per protocol
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
S
Shanon Matkin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here