Uterine LeiomyosarcomaPhase 2NCT05649956
Letrozole in Uterine Leiomyosarcoma
A Phase 2 study testing Letrozole in people with Uterine Leiomyosarcoma, run by GOG Foundation at 34 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Leiomyosarcoma
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 34 sitesUnited States
- Study dates
- 17 Jul 2024to 30 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.
- 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.
- Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of ER status testing in the IRT Source Document Portal.
- Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.
- All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI.
- Patients must have an ECOG performance status of 0, 1, or 2.
Show all 19Show fewer
- Patients must have adequate organ and marrow function as defined below:
- NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN
- Bone marrow function:
- Absolute neutrophil count (ANC) greater than or equal to 1500 cells/mcl
- Platelet count greater than or equal to 100,000 cells/mcl
- Hemoglobin greater than or equal to 9.0 g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the Investigator. Initial treatment must not begin earlier than the day after erythrocyte transfusion).
- Renal function:
- Serum creatinine less than or equal to 1.5 x ULN
- Hepatic function:
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) less than or equal to 3.0 x ULN
- Serum albumin greater than or equal to 2.5 g/dL
- Patient must be at least 18 years of age.
- Patient must be able to swallow oral medication.
Who cannot join
- Exclusion Criteria 1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors are permitted).
- 2. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
- 3. Patients with concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
- 4. Patients who have a history of taking any aromatase inhibitor within the past 5 years.
- 5. Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled hypertension (defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm HR despite antihypertensive medications), unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure (NYHA Class II or greater), clinically significant cardiac arrhythmias, and cardiomyopathy with an ejection fraction under 40%.
- 7. Patients currently receiving chemotherapy or radiation therapy. 8. Patients with severe hepatic impairment and/or cirrhosis. 9. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication.
Show all 9Show fewer
- 10. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion.
- 11. Patients with known hypersensitivity to any of the excipients of letrozole. 12. Patients who are pregnant or breast-feeding. 13. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days of prior to enrollment.
- 14. Patients currently using systemic estrogens, including herbals and supplements with estrogenic properties. The use of vaginal estrogen is permitted if symptoms are refractory to moisturizers and lubricants.
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shanon Matkin contact
34 sites in 1 country
United States34 sites, 34 recruiting
- Recruiting
ProMedica Charles and Virginia Hickman Hospital,
Adrian, Michigan, 49221
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
Mollie Dedig, mdedig@salud.unm.edu
Carolyn Muller
- Recruiting
Winship Cancer Institute, Emory Hospital
Atlanta, Georgia, 30322
Ashley Trumbull, ashley.lynn.trumbull@emory.edu
Susan Modesitt, MD
- Recruiting
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
Bradley Corr, MD
- Recruiting
OhioHealth Arthur G.H. Bing, MD Cancer Center
Columbus, Ohio, 43214
Aine Clements, MD, aine.clements@ohiohealth.com
Aine Clements, MD
- Recruiting
OhioHealth Research Institute
Columbus, Ohio, 43214
Aine Clements, MD, aine.clements@ohiohealth.com
Aine Clements, MD
- Recruiting
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
Aine Clements, MD, aine.clements@ohiohealth.com
Aine Clements, MD
- Recruiting
OhioHealth Grant Medical Center
Columbus, Ohio, 43215
Aine Clements, MD, aine.clements@ohiohealth.com
Aine Clements, MD
- Recruiting
ProMedica Defiance Regional Hospital
Defiance, Ohio, 43512
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
Endeavor Health - Kellogg Cancer Center
Evanston, Illinois, 60201
Michele Britto, mbritto@northshore.org
Endeavor Health - Kellogg Cancer Center Jenkins-Vodel, MD
- Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Linda Borus, lborus@browardhealth.org
Scott Jordan, MD
- Recruiting
ProMedica Fostoria Community Hospital
Fostoria, Ohio, 44830
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
ProMedica Memorial Hospital
Fremont, Ohio, 43420
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
East Carolina University Health Medical Center
Greenville, North Carolina, 27834
Logan Ivey, logan.Ivey@ecuhealth.org
Grainger Lanneau, MD
- Recruiting
Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
Bradley Corr, MD
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Grace Lander, glander@iu.edu
Lisa Landrum, MD
- Recruiting
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
Jacky Amador, jamador@wccenter.com
Nicola Spirtos, MD
- Recruiting
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89511
Shannon Pierpoint, spierpoint@cohreno.com
Peter Lim, MD
- Recruiting
OhioHealth Marion General Hospital
Marion, Ohio, 43302
Aine Clements, MD, aine.clements@ohiohealth.com
Aine Clements, MD
- Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Yvonne Enriquez-Nunez, yxe97@med.miami.edu
Brian Slomovitz, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jordan Mattson, MD, dkteoh@umn.edu
Jordan Mattson, MD
- Recruiting
ProMedica Monroe Regional Hospital
Monroe, Michigan, 48162
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
Atlantic Health System
Morristown, New Jersey, 07960
Nana Tchabo, MD, nana.tchabo@atlantichealth.org
Nana Tchabo, MD
- Recruiting
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Carla Laborde, cscion@lsuhsc.edu
Tara Castellano, MD
- Recruiting
University of Oklahoma Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Laura Holman, laura-l-holman@ouhsc.edu
Laura Holman, MD
- Recruiting
Bay Park Hospital
Oregon, Ohio, 43616
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
ProMedica Laboratories Perrysburg
Perrysburg, Ohio, 43551
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
Woman and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Emma Locke, elocke@wihri.org
Matthew Oliver, MD
- Recruiting
WK Physician Network-Gynecologic Oncology Associates
Shreveport, Louisiana, 71103
Jennifer Cory, j.cory@trials365.org
Destin Black, MD
- Recruiting
Overlook Medical Center
Summit, New Jersey, 07901
Nana Tchabo, MD, nana.tchabo@atlantichealth.org
Nana Tchabo, MD
- Recruiting
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Anjalika Gandi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Anjalika Gandhi, MD, MS, Anjalika.Gandhi@ProMedica.org
Carissa Jock, Carissa.Jock@ProMedica.org
- Recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Ashley Douglas, ashley.douglas.2@jefferson.edu
Tommy Buchanan, MD
- Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
Cara Gregoire, Cara.gregoire@umassmed.edu
Susan Zweizig, MD
About this study
Official title: A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
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.
Read the detailed 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.
- Conditions
- Uterine Leiomyosarcoma
- Being tested
- Letrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Letrozole 2.5 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Experimental | Letrozole 2.5 mg orally Receives: Drug: Letrozole |
| Observation | No intervention | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: Measured from time of enrollment until date of progression or death up 3 years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start17 Jul 2024
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GOG Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Bradley Corr, MD, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649956
- Sponsor's protocol ID
- GOG-3088
- Status last verified
- Jul 2026
- First submitted
- 6 Dec 2022
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma
- ClinicalTrials.gov ID
- NCT05649956
- Acronym / sponsor ID
- GOG-3088
- Conditions
- Uterine Leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GOG FoundationResearch network
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Experimental | Drug: LetrozoleLetrozole 2.5 mg orally |
| Observation | No intervention | –Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.
- 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.
- Patient tumors must express ER positivity by immunohistochemistry (ER expression greater than 10% by immunohistochemistry). ER status test results must be provided at enrollment. Sites are required to report results of ER status testing in the IRT Source Document Portal.
- Patient must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from enrollment.
- All patients must have NO measurable disease as defined by RECIST 1.1 within 6 weeks of enrollment. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI.
Key exclusion criteria (9 listed)
- Exclusion Criteria 1. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors are permitted).
- 2. Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
- 3. Patients with concomitant invasive malignancy or a history of prior malignancy except non-melanoma skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
- 4. Patients who have a history of taking any aromatase inhibitor within the past 5 years.
- 5. Patients with active or uncontrolled systemic infection. 6. Patients with history of uncontrolled cardiac disease, i.e., uncontrolled hypertension (defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm HR despite antihypertensive medications), unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure (NYHA Class II or greater), clinically significant cardiac arrhythmias, and cardiomyopathy with an ejection fraction under 40%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleLetrozole 2.5 mg PO daily | Drug | Letrozole |
Primary outcome
Progression Free Survival
Time frame: Measured from time of enrollment until date of progression or death up 3 years from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Uterine Leiomyosarcoma
RecruitingPhase 2
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS
Uterine Leiomyosarcoma
Active, not recruitingPhase 2/3
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
Locally Advanced Uterine Corpus Leiomyosarcoma, Metastatic Uterine Corpus Leiomyosarcoma
RecruitingPhase 2
Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour
Leiomyosarcoma Uterus
Active, not recruitingPhase 2
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
Stage III Uterine Corpus Leiomyosarcoma AJCC v8, Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
RecruitingPhase 2
Ph 2 Elacestrant in ER Positive Uterine Sarcomas
Uterine Sarcoma, Uterine Leiomyosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanon Matkin contact
Bradley Corr, MD study chair
University of Colorado, Denver
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole in people with Uterine Leiomyosarcoma, run by GOG Foundation at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarin Chhab (2158540770, schhab@gog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Measured from time of enrollment until date of progression or death up 3 years from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.