RECRUITING

Letrozole in Uterine Leiomyosarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Phase II Study of Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

Quick Facts

Study Start:2024-07-17

Study Completion:2029-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05649956

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient must have histologically confirmed uterine leiomyosarcoma with disease limited to the uterus (FIGO stage 1 or 2). 2. Tumors must express ER positivity by immunohistochemistry (ER expression greater than or equal to 10% by immunohistochemistry). 3. Must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from initiation of therapy 4. All patients must have no measurable disease within 6 weeks of initiation of therapy. Measurable disease is defined by RECIST version 1.1. 5. Patient must be able to swallow oral medications. 6. Patient must have an ECOG performance status of 0 to 2. 7. Patients must have adequate organ and marrow function as defined below 8. Patients must have signed an approved informed consent and authorization permitting release of personal health information. 9. Patients must be at least 18 years of age.	1. Patients who have a history of taking any aromatase inhibitor. 2. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors). 3. Patients with active or uncontrolled systemic infection 4. Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past two years. Patients are also excluded if their previous cancer treatment contraindicates this protocol. 5. Patients who are pregnant or breast-feeding. 6. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing. 7. 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. 8. Patients with history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction under 40%. 9. Patients currently receiving chemotherapy or radiation therapy. 10. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication 11. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion

Inclusion Criteria

Exclusion Criteria

1. Patient must have histologically confirmed uterine leiomyosarcoma with disease limited to the uterus (FIGO stage 1 or 2).
2. Tumors must express ER positivity by immunohistochemistry (ER expression greater than or equal to 10% by immunohistochemistry).
3. Must have completed hysterectomy and bilateral salpingo-oopherectomy no more than 12 weeks from initiation of therapy
4. All patients must have no measurable disease within 6 weeks of initiation of therapy. Measurable disease is defined by RECIST version 1.1.
5. Patient must be able to swallow oral medications.
6. Patient must have an ECOG performance status of 0 to 2.
7. Patients must have adequate organ and marrow function as defined below
8. Patients must have signed an approved informed consent and authorization permitting release of personal health information.
9. Patients must be at least 18 years of age.

1. Patients who have a history of taking any aromatase inhibitor.
2. Patients who do not have pure uterine sarcomas (i.e., no mixed malignant mullerian tumors).
3. Patients with active or uncontrolled systemic infection
4. Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past two years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
5. Patients who are pregnant or breast-feeding.
6. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 30 days prior to dosing.
7. 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.
8. Patients with history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction under 40%.
9. Patients currently receiving chemotherapy or radiation therapy.
10. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
11. Patients deemed otherwise clinically unfit for clinical trial per investigators discretion

Contacts and Locations

Study Contact

Jennifer Klein, MEd

CONTACT

2158540770

jklein@gog.org

Principal Investigator

Bradley Corr, MD

STUDY_CHAIR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045

United States

Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

United States

WK Physician Network-Gynecologic Oncology Associates

Shreveport, Louisiana, 71103

United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89106

United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89511

United States

Collaborators and Investigators

Sponsor: GOG Foundation

Bradley Corr, MD, STUDY_CHAIR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17

Study Completion Date2029-07-30

Study Record Updates

Study Start Date2024-07-17

Study Completion Date2029-07-30

Terms related to this study

Additional Relevant MeSH Terms

Uterine Leiomyosarcoma